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NEWS FROM BIOPROCESS TECHNOLOGY CONSULTANTS
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LEVINE OF BIOPROCESS TECHNOLOGY CONSULTANTS TO HOLD BOOK SIGNING AT BIO
ACTON, MASSACHUSETTS, April 30, 2010 — Howard L. Levine, Ph.D., president and founder of BioProcess Technology Consultants, will hold a book signing at the 2010 BIO International Convention, May 3-6, in Chicago, Illinois.
Howard L. Levine, Ph.D., BioProcess Technology Consultants president and founder, will be signing the newly released report, The Development of Therapeutic Monoclonal Antibody Products, in the BIO Store from 1:00 PM – 2:30 PM on May 4 during the 2010 BIO International Convention, May 3-6, in Chicago, Illinois. The 334-page report is a comprehensive review and analysis of the Chemistry, Manufacturing, and Control (CMC) activities and regulatory requirements for the development of monoclonal antibody products from initial discovery through First-In-Human clinical trials. The report, authored by BioProcess Technology Consultants with critical input and review by GE Healthcare, also includes information on late-stage development and commercialization of these important biologic products and presents strategies for accelerating their development while minimizing risks and costs.
“Given the growing number of monoclonal antibody products in development, full knowledge and understanding of all aspects of development, manufacture, and quality control of these products is critical. This report offers essential strategic advice to senior executives and program managers on these critical issues and also provides a valuable technical and regulatory roadmap for the critical CMC activities required for the successful development of monoclonal antibody,” said Dr. Levine.
For more information or to order a copy of The Development of Monoclonal Therapeutic Antibody Products, go to http://www.bioprocessconsultants.com/mabreport.php, call 978-266-9114, or email info@bioprocessconsultants.com. The report is available in hard-copy format only for $1,595. Copies of the report will also be available for purchase at the BIO Store May 3-6, 2010.
About BioProcess Technology Consultants, Inc.
Founded in 1994, BioProcess Technology Consultants is the recognized worldwide leader in biologics CMC consulting, providing a full range of technical, regulatory, and strategic assistance to pharmaceutical and biotechnology companies in the development and commercialization of new biopharmaceutical products. The company specializes in helping clients develop manufacturing processes and strategies and assists in developing product discovery and process development programs that help speed products from clone to commercial.® BioProcess Technology Consultants also helps investors make informed decisions by providing technical and business evaluations of new products and technologies and product discovery, development, and commercialization plans of potential investments and existing portfolio companies. For more about BioProcess Technology Consultants, visit http://www.bioprocessconsultants.com.
BIOPROCESS TECHNOLOGY CONSULTANTS' LEVINE, JONES AND SEYMOUR TO SPEAK AT BIO
ACTON, MASSACHUSETTS, April 28, 2010 – Howard L. Levine, Ph.D., President, Susan Dana Jones, Ph.D., Vice President and Senior Consultant, and Patricia Seymour, Senior Consultant, of BioProcess Technology Consultants will be featured speakers at the 2010 BIO International Convention, May 3-6, in Chicago, Illinois.
Dr. Levine will chair the panel discussion, “Disruptive Technologies for the Future of Biomanufacturing,” in the Exciting Science Session of the main conference at 8:00 AM on Tuesday, May 4. The panel will address recent developments in biomanufacturing technology that may transform the global biologics and vaccines industries, including revolutionary technologies that could disrupt the current cell culture-based manufacturing paradigm. Dr. Levine will also be interviewed by Laura Bush, Editor of BioPharm International, on Wednesday, May 5, on “The State of the Art of Process Development and Manufacturing Technologies for Monoclonal Antibodies” at the BioPharm Vidcasting & Networking Theatre Booth in the BIO Exhibition Hall. He will cover highlights of BioProcess Technology Consultants’ recent report, The Development of Therapeutic Monoclonal Antibody Products.
Dr. Jones will be interviewed on Wednesday, May 5, by Jim Miller, President of PharmSource, about “How Outsourcing Can Accelerate Early CMC Development” at the BioPharm Vidcasting & Networking Theatre Booth in the BIO Exhibition Hall. She will draw upon her experience and case studies to address the benefits of using third party organizations to perform some or all aspects of development.
Ms. Seymour will discuss “The Challenges of Demonstrating Comparability of Biosimilar Products,” at 11:30 AM on Wednesday, May 5, at the BioProcess International BioProcess Zone, Booth #5038 in the BIO Exhibition Hall. She will discuss the CMC issues of cell line development, process development, analytical methods development, and manufacturing critical in developing a biosimilar product and demonstrating its comparability with the innovator reference.
“The BIO International Convention is the foremost global gathering of the industry’s innovators, business leaders, and decision makers, and we are pleased attendees will be able to benefit from our insight and experience in the development and manufacturing of biologic products,” said Dr. Levine. For more details, see the BIO conference website at http://convention.bio.org.
In addition to these presentations and interviews, several BioProcess Technology Consultants reports will be available for sale in the BIO Store throughout the conference. The Development of Therapeutic Monoclonal Antibody Products (February 2010) is a comprehensive review and analysis of the Chemistry, Manufacturing, and Control (CMC) activities for the development of monoclonal antibody products, from discovery through First-In-Human clinical trials. Good Manufacturing Practice, Good Laboratory Practice, and Good Clinical Practice guides analyze the latest GxP regulations and guidances in the US, Canada, the European Union, and Japan.
About BioProcess Technology Consultants, Inc.
Founded in 1994, BioProcess Technology Consultants is the recognized worldwide leader in biologics CMC consulting, providing a full range of technical, regulatory, and strategic assistance to biopharmaceutical and biotechnology companies in the development and commercialization of biopharmaceutical products. The company specializes in helping develop manufacturing processes and strategies and assists in developing product discovery and process development programs to speed products from clone to commercial.® BioProcess Technology Consultants also helps investors make informed decisions by providing technical and business evaluations of new products and technologies and product discovery, development, and commercialization plans of potential investments and existing portfolio companies. For more about BioProcess Technology Consultants, visit http://www.bioprocessconsultants.com.
BIOPROCESS TECHNOLOGY CONSULTANTS RELEASES UPDATED REGULATORY COMPLIANCE GUIDES
ACTON, MA, April 13, 2010 — BioProcess Technology Consultants announces the publication of an updated series of guides to the US and international regulations governing the research, development, and manufacture of biotechnology and pharmaceutical products, commonly referred to as the “GxP Regulations.”
The three guides, Good Manufacturing Practice, Good Laboratory Practice, and Good Clinical Practice, present an up-to-the-minute analysis of all the regulations covered, summarizing the latest GxP regulations and guidances issued by regulatory authorities in the US, Canada, the European Union, and Japan.
The series, now in its fourth edition, is intended to aid companies seeking information and practical advice on efficiently establishing full GxP regulatory compliance. Guides provide simple and concise interpretation of regulations and outline effective solutions for their implementation in the nonclinical, manufacturing, and clinical environments. They include templates for SOPs, and other forms that can be copied and used directly. “In addition to being stand-alone references to the complex GxP regulations, these guides can also serve as manuals for in-house training courses,” said Patricia Seymour, BioProcess Technology Consultants Senior Consultant and co-author of the guides. “Several top-tier companies have used previous editions for training, and we expect others to do the same with these updated versions,” added Ms. Seymour.
“These guides provide clear recommendations for full GxP compliance with the global regulatory requirements and will be a valuable tool whether you are an academic, start-up company or well-establish commercial entity,” commented BioProcess Technology Consultants president and founder Howard L. Levine, Ph.D.
Each report is available through BioProcess Technology Consultants in hard copy for $499 and purchasers buying all three guides will receive a discount on the overall purchase price. For detailed information and to order, visit http://www.bioprocessconsultants.com/regulatorycomplianceguides.php.
About BioProcess Technology Consultants, Inc.
Founded in 1994, BioProcess Technology Consultants is a worldwide leader in biologics CMC consulting, providing a full range of technical, regulatory, and strategic assistance to pharmaceutical and biotechnology companies in the development and commercialization of new biopharmaceutical products. The company specializes in helping clients develop manufacturing processes and strategies and assists in developing product discovery and process development programs that help speed products from clone to commercial.® It helps investors make informed decisions by providing technical and business evaluations of new products and technologies and product discovery, development, and commercialization plans of potential investments and existing portfolio companies. It regularly assists clients in developing GxP compliant systems and also provides GxP auditing services. For more about BioProcess Technology Consultants, visit http://www.bioprocessconsultants.com.
BIPROCESS TECHNOLOGY CONSULTANTS LAUNCHES THE BIOPROCESS BLOG
ACTON, MASSACHUSETTS, April 1, 2010—BioProcess Technology Consultants, Inc., a leader in biologics CMC (Chemistry, Manufacturing and Control) consulting, has launched The BioProcess Blog (http://www.bioprocessblog.com) a new website for sharing information and ideas on biopharmaceutical product development and related issues.
Howard L. Levine, Ph.D., founder and president of the company, will head the blog, which will cover everything from issues related to process development and manufacturing strategies to current topics in the regulation of biopharmaceuticals to the commercialization of biopharmaceutical products. “The BioProcess Blog will expand the information already available on our website [http://www.bioprocessconsultants.com] and provide a forum for discussing current trends, challenges, and opportunities in the biopharmaceutical industry,” said Dr. Levine. “There are issues and questions on everyone’s mind regarding the technical, strategic, and regulatory aspects of biopharmaceutical development and commercialization. The goal of the BioProcess Blog is to help clients, colleagues and others in the field find the answers.”
Aside from Dr. Levine, all members of the BioProcess Technology Consultants staff will contribute to blogs posted on the BioProcss Blog. In addition, BioProcess Technology Consultants will periodically post invited blogs from other industry experts. “By including blogs from recognized leaders in the biotechnology industry, we hope to make the BioProcess Blog a valuable resource and provide an outlet for discussion of important trends and issues in our industry,” said Dr. Levine.
Dr. Levine founded BioProcess Technology Consultants in 1994, and has grown it into a global leader in consulting for the pharmaceutical and biotechnology industries. Before that, he was Vice President of Manufacturing Operations at Repligen Corporation and has held positions in process development and manufacturing at Genentech, Amgen, and Xoma. He is a member of the Editorial Advisory Boards of BioPharm Magazine and Bio/Pharmaceutical Outsourcing Report, the Scientific Advisory Boards of Pall Corporation and Biologics Process, Inc., and the Board of Directors of Protein Sciences Corporation. Dr. Levine holds a Ph.D. in chemistry from the University of Chicago and completed a post-doctoral fellowship at Harvard University.
About BioProcess Technology Consultants, Inc.
Founded in 1994, BioProcess Technology Consultants is a worldwide leader in biologics CMC consulting, providing a full range of technical, regulatory, and strategic assistance to pharmaceutical and biotechnology companies in the development and commercialization of new biopharmaceutical products. The company specializes in helping clients develop manufacturing processes and strategies and assists in developing product discovery and process development programs that help speed products from clone to commercial.® BioProcess Technology Consultants helps investors make informed decisions by providing technical and business evaluations of new products and technologies and product discovery, development, and commercialization plans of potential investments and existing portfolio companies. The company also assists clients in developing GxP compliant systems and also provides GxP auditing services. For more about BioProcess Technology Consultants, visit http://www.bioprocessconsultants.com.
BIOPROCESS TECHNOLOGY CONSULTANTS PUBLISHES REPORT ON DEVELOPMENT OF THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS
ACTON, MA, February 11, 2010 – BioProcess Technology Consultants, Inc. announces publication of The Development of Therapeutic Monoclonal Antibody Products, a 334-page comprehensive review and analysis of the Chemistry, Manufacturing, and Control (CMC) activities and regulatory requirements for the development of monoclonal antibody products, from initial discovery, through First-In-Human clinical trials. The report, by BioProcess Technology Consultants, and produced with critical input and review by GE Healthcare, also includes information on late-stage development and commercialization of these important biologic products and presents strategies for accelerating their development while minimizing risks and costs.
“Drawing on our extensive knowledge of all aspects of monoclonal antibody development and manufacture, this report offers essential strategic advice to senior executives and program managers on the critical issues associated with monoclonal antibody development and also provides a valuable technical and regulatory roadmap for the critical CMC activities required to bring these products to market,” said BioProcess Technology Consultants president and founder Howard L. Levine, Ph.D. “At a time of increasing attention on monoclonal antibodies as a class of therapeutic products, we provide decision makers with in-depth analysis and recommendations for early stage product development, including detailed information on cell culture and purification process development, manufacturing, quality control, and analysis of full-length single-specificity monoclonal antibody products and the current regulatory requirements for these products.”
Dr. Günter Jagschies, Senior Director, BioTechnologies R&D, GE Healthcare, said: “In addition to the technical and regulatory requirements for monoclonal antibody product development, the report also discusses manufacturing economics from the production of early stage clinical trial material through large-scale commercial manufacturing. Senior management will find the analysis of manufacturing costs useful in evaluating manufacturing options and strategies, minimizing the cost of manufacturing mature products, analyzing production demand and financial priorities, and implementing technical options for performance improvement.”
For more information or to order a copy of The Development of Monoclonal Therapeutic Antibody Products, go to http://www.bioprocessconsultants.com/mabreport.php, email info@bioprocessconsultants.com, or call 978-266-9114. The report is available in hard-copy format only for $1,595.
About BioProcess Technology Consultants, Inc.
Founded in 1994, BioProcess Technology Consultants is the recognized worldwide leader in biologics CMC consulting, providing a full range of technical, regulatory, and strategic assistance to pharmaceutical and biotechnology companies in the development and commercialization of new biopharmaceutical products. The company specializes in helping clients develop manufacturing processes and strategies and assists in developing product discovery and process development programs that help speed products from clone to commercial.® BioProcess Technology Consultants also helps investors make informed decisions by providing technical and business evaluations of new products and technologies and product discovery, development, and commercialization plans of potential investments and existing portfolio companies. For more about BioProcess Technology Consultants, visit http://www.bioprocessconsultants.com.
BIOPROCESS TECHNOLOGY CONSULTANTS' LEVINE, JONES AND KANAREK FEATURED AT BIO INTERNATIONAL CONVENTION
ACTON, MASSACHUSETTS, May 11, 2009 – Howard L. Levine, Ph.D., President, Susan Dana Jones, Ph.D., Vice President and Senior Consultant, and Alex Kanarek, Ph.D., Senior Consultant, of BioProcess Technology Consultants will be featured speakers at the 2009 BIO International Convention, May 18-22, in Atlanta, Georgia.
Dr. Levine will chair a roundtable session in the Manufacturing Breakout Session of the main conference at 2:00 PM on Monday, May 18, and will speak on “A World of Biomanufacturing: Shortages or Global Glut?” He will highlight the fast-changing economics and range of global models emerging for biomanufacturing and how these new approaches impact the global supply and demand for biomanufacturing capacity. On Wednesday, May 20, Dr. Levine will also be interviewed by Jim Miller of PharmSource Information Services at the BioPharm Vidcasting & Networking Theatre Booth #2851 in the BIO Exhibition Hall. He will talk on “Outsourcing Capacity & Decision-Making,” covering the many strategic manufacturing decisions required throughout product development, the pros and cons of alternate manufacturing systems, and updates on cell culture and microbial fermentation capacity.
Dr. Jones will discuss “Challenges in Vaccine Production and Rapid Scale-Up to Meet Emerging Pandemic Threat,” at 10:30 AM on Wednesday, May 20, including alternative production methods for influenza vaccines that could speed up response to potential pandemics and improve the economics of vaccine manufacturing. Dr. Kanarek will provide an analysis of the 2008 FDA Draft Guidance on Process Validation in his presentation “Process Validation for the 21st Century” at 10:30 AM on Thursday, May 21. Dr. Jones and Dr. Kanarek will speak at the BioProcess International BioProcess Product Focus Zone, Booth #5113 in the BIO Exhibition Hall. They are both on the Editorial Advisory and Peer Review Board of BioProcess International.
“The BIO International Convention is the foremost gathering of the industry’s innovators, business leaders, and decision makers, and we are pleased to be a part of this global event,” said Dr. Levine. “Our presentations will provide valuable information to conference attendees, allowing them to benefit from our insight and experience in the development and manufacturing of biologic products.”
Further details on the presentations and interview may be found at the BIO conference website at http://convention.bio.org.
About BioProcess Technology Consultants, Inc.
Founded in 1994, BioProcess Technology Consultants provides a full range of strategic, technical, business, and regulatory assistance to pharmaceutical and biotechnology companies in the development and commercialization of new biopharmaceutical products. The company specializes in helping clients to develop manufacturing processes and strategies and assists in developing product discovery and process development programs that help speed products from clone to commercial®. BioProcess Technology Consultants also helps investors make informed decisions by providing technical and business evaluations of new products and technologies and product discovery, development, and commercialization plans of potential investments and existing portfolio companies. For more about BioProcess Technology Consultants, visit http://www.bioprocessconsultants.com.
HOWARD L. LEVINE ELECTED TO BOARD OF PROTEIN SCIENCES, SWINE FLU VACCINE DEVELOPER
ACTON, MASSACHUSETTS, May 6, 2009 – Howard L. Levine, Ph.D., President of BioProcess Technology Consultants, Inc., has been elected to the Board of Directors of Protein Sciences Corporation, developer of FluBlok® seasonal influenza vaccine and PanBlok® vaccine for the new H1N1 swine flu and other potential pandemic influenza viruses.
Dr. Levine is an international expert in biologics development and manufacturing and provides strategic, technical, and regulatory consulting services to biopharmaceutical companies to help accelerate the development and commercialization of new biopharmaceutical products.
“Dr. Levine’s expertise in cell culture scale-up, plus his knowledge and experience with flu vaccine manufacturing make him a valuable addition as we rapidly scale up to be able to manufacture PanBlok vaccine for the potential swine flu pandemic by early to mid-June,” said Daniel D. Adams, Protein Sciences President, CEO, and newly elected Chairman of the Board of Directors. The company expects its FluBlok vaccine to receive FDA approval in 2009.
Before founding BioProcess Technology Consultants, Dr. Levine was Vice President of Manufacturing Operations at Repligen Corporation, and has held positions in process development and manufacturing at Genentech, Amgen, and Xoma. He is a member of the Editorial Advisory Boards of BioPharm Magazine and Bio/Pharmaceutical Outsourcing Report and is on the Advisory Boards of Acretia Inc., and Nexbio, Inc. He holds a Ph.D. in chemistry from the University of Chicago and completed a post-doctoral fellowship at Harvard University.
"Protein Sciences’ innovative protein expression technology shows great promise in battling the new strain of swine flu," said Dr. Levine. “I’m pleased to join their Board at this pivotal time.”
About BioProcess Technology Consultants, Inc.
Founded in 1994, BioProcess Technology Consultants provides a full range of technical, business, and operations assistance to pharmaceutical and biotechnology companies in the development and commercialization of new biopharmaceutical products. The company specializes in helping clients to develop manufacturing processes and strategies and assists in developing product discovery and process development programs that help speed products from clone to commercial.® BioProcess Technology Consultants also helps investors make informed decisions by providing technical and business evaluations of new products and technologies and product discovery, development, and commercialization plans of potential investments and existing portfolio companies. For more about BioProcess Technology Consultants, visit http://www.bioprocessconsultants.com. For information on Protein Sciences Corporation, go to http://www.proteinsciences.com.
PATRICIA SEYMOUR OF BIOPROCESS TECHNOLOGY CONSULTANTS EARNS CSCSP CERTIFICATION
ACTON, MA, March 23, 2009 – Patricia Seymour, Senior Consultant at BioProcess Technology Consultants, has been certified as a supply chain professional (CSCP) by the Association for Operations Management (APICS), recognizing her proficiency in supply chain management.
“This is a tremendous accomplishment for Patti which we are proud to acknowledge,” said Howard L. Levine, Ph.D., President of BioProcess Technology Consultants. “The APICS CSCP designation represents a commitment to supply chain excellence and demonstrates Patti’s dedication to providing the highest quality support and service to our clients in this area as well as other related CMC activities.”
Candidates who receive the APICS CSCP designation must have significant previous experience in supply chain management, complete a rigorous course of study, and pass a comprehensive examination demonstrating their ability to effectively manage the integration of these activities to maximize a company’s value chain.
Ms. Seymour has been with BioProcess Technology Consultants since 2006. She has more than 20 years of experience in the development and manufacture of biologics and small molecule drugs, has extensive experience in supply chain strategy and management, and has assisted many BioProcess Technology Consultants clients in the areas of CMC strategy planning, project management and supply chain management.
About BioProcess Technology Consultants, Inc.
Founded in 1994, BioProcess Technology Consultants provides a full range of technical, business, and operations assistance to pharmaceutical and biotechnology companies in the development and commercialization of new biopharmaceutical products. The company specializes in helping clients to develop manufacturing processes and strategies and assists in developing product discovery and process development programs that help speed products from clone to commercial.® BioProcess Technology Consultants also helps investors make informed decisions by providing technical and business evaluations of new products and technologies and product discovery, development, and commercialization plans of potential investments and existing portfolio companies. For more about BioProcess Technology Consultants, visit http://www.bioprocessconsultants.com.
PHARMSOURCE AND BIOPROCESS TECHNOLOGY CONSULTANTS ANNOUNCE PUBLICATION OF NEW MARKET REPORT, "CELL CULTURE MANUFACTURING CAPACITY: TRENDS AND OUTLOOK THROUGH 2013"
Pre-release price available through December 15, 2008
FAIRFAX, VA and ACTON, MA, December 2, 2008 — Major biopharmaceutical companies with substantial internal mammalian cell culture capability are forecast to have adequate internal manufacturing capacity. Contract mammalian cell culture manufacturers (CMOs) however, are likely to feel the pressure of increased utilization rates. For these CMOs and biopharmaceutical companies depending on them, understanding critical demand drivers, market factors and manufacturing trends is instrumental to making effective strategic supply decisions.
“Cell Culture Manufacturing Capacity: Trends and Outlook through 2013” provides a timely and detailed examination of these issues. In this definitive report, foremost experts BioProcess Technology Consultants and PharmSource Information Services provide an extensive supply and demand analysis in addition to in-depth recommendations for the cell culture industry. Detailed data points include: product pipeline analysis, probable product success rates, time to market, API requirements, current and planned capacity, process yields and the potential impact of technology advances including biosimilars.
“This report offers valuable strategic insight to support critical 'make or buy' decisions for mammalian cell culture manufacturers, key recommendations for capital investments and clear pricing strategy direction for the biologics contract manufacturing industry,” comments BioProcess Technology Consultants president and founder Howard L. Levine, Ph.D. PharmSource president and founder, Jim Miller, concurs, “At a time of so much uncertainty in the biopharmaceutical industry, this analysis provides decision makers with the in-depth understanding they need to may critical API supply decisions.”
The $4,950 report will be offered at the $700 pre-order discount price of $4,250 through December 15, 2008. For more detailed information and ordering instructions visit:
http://www.pharmsource.com/forms.cfm?id=32.
About the Authors
Founded in 1994, BioProcess Technology Consultants, Inc. is the leading provider of strategic, technical, operational, and regulatory consulting services to the biopharmaceutical industry and the industry’s foremost expert on cell culture manufacturing. The company specializes in helping clients speed their products from clone to commercial®. Visit BioProcess Technology Consultants on the web at http://www.bioprocessconsultants.com or contact them at 978-266-9113.
PharmSource Information Services, Inc. is a respected provider of contract drug development and manufacturing intelligence. Since 1996 PharmSource has assisted biotechnology and pharmaceutical companies with the implementation and management of sourcing strategies and tactics through insightful publications, analyses and intelligence services. Visit PharmSource on the web at http://www.pharmsource.com or contact them at 703-383-4903.
BIOPROCESS TECHNOLOGY CONSULTANTS APPOINTS KANAREK, FULTON, AND CONWAY AS CONSULTANTS
ACTON, MA, September 18, 2008 — BioProcess Technology Consultants, Inc., a leading provider of technical and regulatory services to the biopharmaceutical industry worldwide, announced the appointment of Alex Kanarek, Ph.D., and Scott P. Fulton as Senior Consultants, and Robert Conway, Ph.D., as Consultant and Director, Business Development.
Dr. Kanarek, Senior Consultant, brings expertise in large-scale manufacturing, regulatory compliance, and quality assurance. He is an expert in vaccine development and manufacture and was formerly Director of Product Development at Connaught Laboratories Ltd. (now sanofi pasteur). He has authored numerous books and reports on regulatory compliance, including Guides to Good Manufacturing Practice and Good Laboratory Practice. In 1993, Dr. Kanarek established an independent consulting practice. He has worked with the company as a subcontractor since 2006. He holds a Ph.D. from Cambridge University.
Mr. Fulton, Senior Consultant, has an extensive background in large-scale purification technology, biomolecule analysis, economic modeling of biopharmaceutical manufacturing, transgenic production, and business strategies. He was Vice President of Program Management at Genzyme Transgenics (now GTC Biotherapeutics) and has held senior management positions at Amicon and PerSeptive Biosystems. Mr. Fulton is also the founder of BioSystem Development and remains CEO and a member of the company’s board of directors. He holds dual B.S. degrees in physics and applied biology and an M.S. degree in biomedical engineering, all from MIT.
Dr. Conway, Consultant and Director, Business Development, has extensive experience in membrane filtration of biological and small molecule pharmaceuticals and has held positions with both technical and commercial responsibilities. He was previously at 3M-Cuno, Inc. as Director of Marketing and Associate Director of Scientific Applications Support Services. Previously, he held senior positions in marketing and technical services at Pall Corporation. Dr. Conway holds a Ph.D. in microbiology from Emory University School of Medicine.
“Together, Dr. Kanarek, Mr. Fulton and Dr. Conway broaden our experience in all aspects of biologics development and manufacturing,” said Howard L. Levine, Ph.D., founder and president of the company. “They know the complex issues facing biopharmaceutical companies on their way to commercialization and can provide our clients with the insights they need to succeed in the global economy. We’re delighted to have them on our team.”
About BioProcess Technology Consultants, Inc.
Founded in 1994, BioProcess Technology Consultants provides a full range of strategic, technical, business, and regulatory assistance to pharmaceutical and biotechnology companies in the development and commercialization of new biopharmaceutical products. The company specializes in helping clients to develop manufacturing processes and strategies and assists in developing product discovery and process development programs that help speed products from clone to commercial.® BioProcess Technology Consultants also helps investors make informed decisions by providing technical and business evaluations of new products and technologies and product discovery, development, and commercialization plans of potential investments and existing portfolio companies. For more about BioProcess Technology Consultants, visit http://www.bioprocessconsultants.com.>back to top
BIOPROCESS TECHNOLOGY CONSULTANTS' LEVINE AND JONES FEATURED AT BIO EXHIBITION
ACTON, MASSACHUSETTS, June 6, 2008 – Howard L. Levine, Ph.D., President, and Susan Dana Jones, Ph.D., Vice President and Senior Consultant of BioProcess Technology Consultants, will be featured speakers at the 2008 BIO International Convention, June 17-20, in San Diego, California.
Dr. Levine and Dr. Jones will both speak at BioProcess International’s BioProcess Product Focus Zone. The BioProcess Product Focus Zone, which features industry experts presenting the latest information about developing processes and products, will be held at Theater Booth #2438 in the BIO Exhibition Hall. Dr. Jones is on the editorial board of BioProcess International.
Dr. Levine’s presentation at 3:45 PM on Tuesday, June 17, will be “Efficient Project Management of Biopharmaceutical Development: Ensuring On-Time and Compliant Development Programs.” He will present project-management tools to help identify critical path items, ensure proper allocation of resources, and orchestrate the interplay and dependencies of wide-ranging CMC activities with preclinical and clinical activities to maximize the probability of successful product development.
Dr. Jones will speak at 3:30 PM on Thursday, June 19, on “Challenges in Scaling Up Newly Developed Microbial Manufacturing Processes,” and will describe an approach to streamlined development and scale-up of a microbial manufacturing process developed at small scale in an E. coli production host. The parameters for scaled-up production were based on multiple process demonstration runs at smaller scale. Fermentation scale-up directly from laboratory scale to the 1,000-L scale was seamless in most parameters because of a wealth of information obtained at the small scale. Dr. Jones will review and discuss some operations that did not transfer perfectly in order to identify small-scale activities and approaches that can increase the success rate of scale-up.
Dr. Levine will also be featured in a live podcast at 2:15 PM on Thursday, June 19, on “Trends in the Development of Fc-Fusion Proteins.” He will give an overview of this increasingly important class of biopharmaceutical products and compare and contrast the development and manufacturing requirements and costs of these products with conventional monoclonal antibodies.The podcast interview will be conducted in the Lobby outside Exhibit Hall A.
Further details on the presentations and podcast may be found at the BIO conference website at www.bio2008.org.
About BioProcess Technology Consultants, Inc.
Founded in 1994, BioProcess Technology Consultants provides a full range of strategic, technical, business, and regulatory assistance to pharmaceutical and biotechnology companies in the development and commercialization of new biopharmaceutical products. The company specializes in helping clients to develop manufacturing processes and strategies and assists in developing product discovery and process development programs that help speed products from clone to commercial.® BioProcess Technology Consultants also helps investors make informed decisions by providing technical and business evaluations of new products and technologies and product discovery, development, and commercialization plans of potential investments and existing portfolio companies. For more about BioProcess Technology Consultants, visit http://www.bioprocessconsultants.com
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BIOPROCESS TECHNOLOGY CONSULTANTS EXPANDS IN EUROPE THROUGH L&K BIOSCIENCES ALLIANCE
ACTON, MA, April 7, 2008 – BioProcess Technology Consultants, a leading international biopharmaceutical technical, strategic, and CMC (Chemistry, Manufacturing, and Controls) regulatory consulting group, has announced a strategic alliance with L&K Biosciences (L&K) of Copenhagen, Denmark to expand its CMC consulting services throughout Europe.
The two companies will jointly market their services worldwide. Clients of both companies will have access to the full range of technical, operations, and regulatory services of both BioProcess Technology Consultants and L&K Biosciences.
“This alliance will enable us to expand our operations and provide seamless oversight of development and manufacturing programs worldwide,” said Howard L. Levine, Ph.D., President of BioProcess Technology Consultants. “We are excited to combine our expertise and long-term success with L&K’s European presence and extensive experience in the biopharmaceutical industry.”
“We are pleased to be associated with one of the premier CMC consulting firms in the world and look forward to expanding our business and collaborating with BioProcess Technology Consultants to provide value added solutions to biopharmaceutical companies world-wide,” said Lars Skriver, Ph.D., Managing Director and Co-Founder of L&K.
BioProcess Technology Consultants’ clients will also gain access to the L&K Process Guide (www.bioprocessguide.com) for biopharmaceutical drug development and manufacture, a key reference tool for scientists and engineers involved in process development and scale-up.
“We are fortunate to have expert input from BioProcess Technology Consultants to enrich the next generation of the Process Guide as we continue to build this definitive source of information on the development and manufacture of biologic drug substances and products,” said Kim Hejnaes, Partner and Co-Founder of L&K.
The two companies will also integrate their current project management programs and develop sophisticated new tools to monitor all CMC activities throughout the product development lifecycle. These new tools will be designed to improve the efficacy of drug development programs by continuously tracking program activities, budgets, and timelines, and help expedite electronic regulatory submissions through the use of multi-level linked documents and reports.
About BioProcess Technology Consultants, Inc.
Founded in 1994, BioProcess Technology Consultants provides a full range of technical, business, and operations assistance to pharmaceutical and biotechnology companies in the development and commercialization of new biopharmaceutical products. The company specializes in helping clients to develop manufacturing processes and strategies and assists in developing product discovery and process development programs that help speed products from clone to commercial.® BioProcess Technology Consultants also helps investors make informed decisions by providing technical and business evaluations of new products and technologies and product discovery, development, and commercialization plans of potential investments and existing portfolio companies. For more about BioProcess Technology Consultants, visit http://www.bioprocessconsultants.com
About L&K Biosciences
L&K Biosciences is a consulting company offering advisory services and management of development and manufacturing of biopharmaceutical drugs. Since it was founded in 1998, L&K Biosciences has assisted more than 45 pharmaceutical and biotech companies in the execution of agreed technical and commercial strategies enabling timely delivery of key business milestones. For more about L&K Biosciences, visit http://www.lk-biosciences.dk
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BIOPROCESS TECHNOLOGY CONSULTANTS NAMES RANSOHOFF AND JONES VICE PRESIDENTS
ACTON, MA, January 17, 2008 -- BioProcess Technology Consultants, specialists in providing development, manufacturing, quality, and regulatory services to pharmaceutical and biotechnology companies, announced the promotions of Thomas C. Ransohoff and Susan Dana Jones, Ph.D., to vice presidents.
Both Mr. Ransohoff and Dr. Jones joined the company in 2002. In these newly formed executive positions, they will assist in expanding the business through strategic and operational leadership and will continue to head and manage client projects as senior consultants. In addition, Mr. Ransohoff will continue to lead and expand the company’s proprietary Supply and Demand databases for biopharmaceutical manufacturing capacity and related information while Dr. Jones will be responsible for launching the company’s new special topics report service.
“Both Tom and Susan have helped shape the company and have contributed to the growth of our business. We value their expert knowledge and extraordinary experience and are pleased they have accepted these greater leadership roles in the organization,” said Howard L. Levine, Ph.D., founder and president of the company.”
Mr. Ransohoff's areas of expertise include development and scale-up of biopharmaceutical processes; separations and purification technologies; cGMP manufacturing; and process economics. Prior to joining BioProcess Technology Consultants, he held senior positions at TranXenoGen, Inc., Dyax Corp, and Repligen Corporation. He has a Bachelor's degree from MIT and a Master's degree from UC-Berkeley, both in Chemical Engineering.
Dr. Jones has significant experience in discovery, product development, and strategic planning. She co-founded two biotechnology companies and has managed development programs in multiple disease areas. She previously held senior positions at Serenex Inc, Waratah Pharmaceuticals, and Dyax Corp. Dr. Jones received her Bachelor's degree from Harvard University and her Ph.D. from the University of California, San Francisco. Dr. Jones is also an Adjunct Associate Professor at the Massachusetts College of Pharmacy and Health Sciences.
About BioProcess Technology Consultants, Inc.
Founded in 1994, BioProcess Technology Consultants provides a full range of technical, business, and operations assistance to pharmaceutical and biotechnology companies in the development and commercialization of new biopharmaceutical products. The company specializes in helping clients to develop manufacturing processes and strategies and assists in developing product discovery and process development programs that help speed products from clone to commercial.® BioProcess Technology Consultants also helps investors make informed decisions by providing technical and business evaluations of new products and technologies and product discovery, development, and commercialization plans of potential investments and existing portfolio companies. For more about BioProcess Technology Consultants, visit http://bioprocessconsultants.com.
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BIOPROCESS TECHNOLOGY CONSULTANTS APPOINTS TURNER, SEYMOUR AND STOCK
ACTON, MA, MAY 22, 2006 -- BioProcess Technology Consultants has appointed Brian G. Turner, Ph.D., Patricia M. Seymour, and Rick Stock, Ph.D. as consultants, expanding to offer more in-depth technical, business and operations services for the development and commercialization of biopharmaceutical products.
Brian Turner joins as a Senior Consultant, Patricia Seymour as a Consultant, and Rick Stock as an Associate Consultant.
“These seasoned consultants add valuable experience and expertise to our fast-growing team,” said Howard L. Levine, Ph.D., founder and president of the company. “Dr. Turner has an impressive record in product commercialization, Ms. Seymour brings her insight into supply-chain management and outsourcing, and Dr. Stock is expert in computer modeling related to manufacturing costs and industry capacity. Their many talents will enrich our existing consulting services and allow us to offer even broader and more complete services to our clients. We are delighted to have them aboard.”
Dr. Turner was most recently Director of Process Sciences for Abbott Bioresearch Center (formerly BASF Bioresearch Corporation) where he led the Global CMC Team that enabled the successful registration of Humira. He holds a B.S. from University of Massachusetts in chemical engineering, and an M.S. and Ph.D. in chemical engineering from Purdue University.
Ms. Seymour was, prior to joining the company, Senior Director of Global Investigational Supply Operations at Millennium Pharmaceuticals, Inc., where she worked with other senior leaders to develop and implement CMC strategies including outsourcing. She has a Bachelor's degree from Villanova University and an M.B.A. from Boston University
Dr. Stock most recently specialized in computer modeling of biological and biomanufacturing systems at BioPharm Services, Inc., and has been assistant director of a pilot biotechnology manufacturing facility at Worcester Polytechnic Institute (WPI). He has a B.S in chemical engineering from The Ohio State University, and an M.S. in chemical engineering and a Ph.D. in biochemical engineering from WPI.
About BioProcess Technology Consultants, Inc.
Founded in 1994, BioProcess Technology Consultants provides a full range of technical, business, and operations assistance to pharmaceutical and biotechnology companies in the development and commercialization of new biopharmaceutical products. The company specializes in helping clients to develop manufacturing processes and strategies and assists in developing product discovery and process development programs that help speed products from clone to clinic.® BioProcess Technology Consultants also helps investors make informed decisions by providing technical and business evaluations of new products and technologies and product discovery, development, and commercialization plans of potential investments and existing portfolio companies. For more about BioProcess Technology Consultants, visit http://bioprocessconsultants.com.
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BIOPROCESS TECHNOLOGY CONSULTANTS TO LEAD WORKSHOP AT CONTRACT MANUFACTURING FORUM
ACTON, MA, May 16, 2006 – Patricia Seymour of BioProcess Technology Consultants will lead the workshop, “Successfully Managing Biopharmaceutical Manufacturing Outsourcing” on May 22 and will co-present with Jason Bertola of Carbogen-Amcis,, “Supplier/Sponsor Relationship: How to Get it Right from the Beginning” on May 24 at the 4th Annual Contract Manufacturing Forum presented by IQPC in San Diego, California.
Ms. Seymour is a Consultant of the Acton, Massachusetts, firm providing manufacturing, process development, quality control and quality assurance assistance to biopharmaceutical clients.
The workshop will focus on critical issues involving the management of contract manufacturers (CMOs) in biopharmaceutical development activities, including process development, formulation development, stability testing, and fill/finish. It will also suggest best practices and proven strategies that attendees can implement when they return to the office.
The presentation will cover the different perspectives a sponsor and supplier bring to the outsourcing relationship and how to balance and optimize them for successful outcomes.
“While qualified CMOs can reduce the time companies need to spend on outsourced activities, sponsors must plan for enough resources to oversee each supplier and each activity outsourced,” said Ms. Seymour. “A dedicated program manager, either from within the sponsor company or an outside consultant, must efficiently manage the supplier and flow of information, the SOPs, and the material in order to stay on time and within budget.”
More information about the workshop and presentation may be found at www.iqpc.com/pharmaIQ.
About BioProcess Technology Consultants, Inc.
Founded in 1994, BioProcess Technology Consultants provides a full range of technical, business, and operations assistance to pharmaceutical and biotechnology companies in the development and commercialization of new biopharmaceutical products. The company specializes in helping clients to develop manufacturing processes and strategies, and assists in developing product discovery and process development programs that help speed products "from clone to clinic.™" BioProcess Technology Consultants also helps investors make informed decisions by providing technical and business evaluations of new products and technologies and of product discovery, development, and commercialization plans of potential investments and existing portfolio companies. For more about BioProcess Technology Consultants, visit http://bioprocessconsultants.com.
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2005 BIOPHARMACEUTICAL MANUFACTURING RERPORT AVAILABLE
ACTON, MA and ROCKVILLE, MD, September 15, 2005 - BioProcess Technology Consultants, Inc., and BioPlan Associates, Inc., have released the 3rd Annual Survey of Biopharmaceutical Manufacturing Capacity and Production, summarizing an industry-wide survey of 187 executives in biopharmaceutical manufacturing and contract manufacturing organizations (CMO).
The study’s findings include estimates that average capacity utilization has decreased approximately 11% since 2003, from 79% to 70%. According to the report, this is probably due to the recent industry-wide expansion of installed mammalian cell culture bioreactor capacity as well as some unexpected product failures. However, the study finds that manufacturing capacity will continue to expand over the next five years.
The 100-page study may be purchased by contacting PSI Fulfillment by calling 800-218-8313 (U.S. only) or 512-288-5021, by fax at 512-288-5055, or online at https://www.psifulfillment.com/orderform.asp?S=PSIPhoneOrder&ID=154
Dr. Howard L. Levine, President of BioProcess Technology Consultants and internationally recognized expert on biopharmaceutical manufacturing, helped prepare the report. Dr. Levine will be presenting the opening lecture at the IBC BioProcess™ International Conference, September 19-22, 2005, in Boston, MA, where he will summarize some of the data in the report. Eric Langer, President of BioPlan Associates, a leading expert on industry trends and the survey director, will also be presenting results of the report in his lecture at the IBC conference.
About BioPlan Associates
BioPlan Associates, Inc., Rockville, MD, has been providing marketing research, planning services, and management training to biopharmaceutical and healthcare companies since 1989. It publishes reports and studies on manufacturing capacity, including Advances in Large-scale Biopharmaceutical Manufacturing and Scale-up Production. http://bioplanassociates.com/
About BioProcess Technology Consultants
Bioprocess Technology Consultants, Inc., Acton, MA, provides technical, business, and operations assistance to pharmaceutical and biotechnology companies in the development and commercialization of new biopharmaceutical products. It is expert in all aspects of chemistry, manufacturing, and control (CMC). http://bioprocessconsultants.com/
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BIOPROCESS TECHNOLOGY CONSULTANTS’ HOWARD LEVINE TO CO-CHAIR BIOPROCESS INTERNATIONAL CONFERENCE
ACTON, MASSACHUSETTS, September 13, 2005 – Howard L. Levine, Ph.D., president, and Tom Ransohoff, senior consultant, of BioProcess Technology Consultants, will be featured at IBC’s BioProcess™ International Conference, September 19-22, 2005, in Boston, MA, with Dr. Levine serving as a co-chair and presenting the opening lecture in the Production and Economics module.
"We have been involved in the Production and Economics segment since the conference’s inception, and are pleased to see it grow into the preeminent conference covering all of the critical aspects of process development, scale-up, and GMP manufacturing of biopharmaceuticals," said Dr. Levine.
In the opening lecture, "The State of Biomanufacturing Capacity – Do We Finally Have Enough?" Dr. Levine will summarize BioProcess Technology Consultants’ most recent analysis of supply and demand for biomanufacturing capacity that indicates demand for cell culture manufacturing capacity will continue to increase, with supply roughly keeping up with demand as several companies bring new and/or renovated facilities online. He will discuss how access to and availability of capacity for companies seeking to outsource production may result in short-term constraints.
Mr. Ransohoff, will co-moderate the discussion group, "Protein Expression Systems: Alternative Ways to Make and Deliver Proteins" Wednesday, September 21. "The industry’s ability to efficiently utilize its manufacturing capacity and lower overall cost of goods is tied to improvements in expression technologies," said Mr. Ransohoff. "This discussion group will provide an interactive forum to review advances in this very important area."
Both Dr. Levine and Mr. Ransohoff serve on the Scientific Advisory Board of the BioProcess International Conference. Dr. Levine is also on the Editorial Board of BioProcess International.
The BioProcess International Conference, which anticipates more than 800 participants, has sought the participation of these senior members of BioProcess Technology Consultants because of the firm’s specialization in the development, scale-up, and manufacture of biotherapeutics. The firm provides a full range of technical, business, and operations consulting services that can accelerate biopharmaceutical development, increase likelihood of success at all stages, and help speed products from clone to clinic™. BioProcess Technology Consultants works closely with its clients to assess product discovery opportunities, design and execute product development strategies, develop and implement robust, cost-effective manufacturing processes, assist with regulatory filings, and oversee manufacturing operations. The company also helps investors make informed decisions by providing technical evaluations of new products and technologies and feasibility assessments of development and commercialization plans of both potential investments and existing portfolio companies.
More information on BioProcess Technology Consultants services is online at www.bioprocessconsultants.com. The BioProcess International Conference provides program details at www.IBCLifeSciences.com/BPI.
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SUSAN DANA JONES TO SPEAK AT BIO
ACTON, MA, June 14, 2005 – Susan Dana Jones, Ph.D., Senior Consultant of BioProcess Technology Consultants, will speak at the BIO 2005 Conference in Philadelphia on June 22, 2005, about the impact of recent changes in the European regulatory guidelines on the cost of biopharmaceutical production for early stage clinical trials.
The BIO (Biotechnology Industry Organization) Conference is the largest biotechnology conference in the US. Dr. Jones will speak in a 4:00-5:30 PM session chaired by Dave Patterson of Diosynth entitled The European Clinical Trial Directive–One Year after Implementation, which will focus on the effect of the European Union’s Clinical Trial Directive (EU CTD) on biopharmaceutical manufacturing strategies and costs. Dr. Jones’s presentation, Impact of European Union Clinical Trial Directive (EU CTD) on Cost of Manufacturing Products for Clinical Trial, will cover compliance issues facing companies wishing to conduct clinical trials in Europe. She will describe how higher costs of compliance may slow the growth of the biopharmaceutical industry in Europe and reduce the probability of discovering valuable new biologic compounds. She will also discuss the potential impact of the EU CTD on the cost of producing biopharmaceuticals for early clinical evaluation.
"The impact of the directive will depend on its interpretation by regulatory agencies. In the most conservative interpretation, it may result in increased costs of entering early clinical development in Europe, forcing these development activities to countries outside the EU," said Dr. Jones.
Howard L. Levine, Ph.D., President of BioProcess Technology Consultants, added, "The EU CTD may significantly affect manufacturing capacity for early stage clinical trial material, since facilities that have served this market in the past may not be equipped to meet the more stringent requirements."
Dr. Jones is a leading expert in the manufacture of clinical trial material and has assisted numerous small biotechnology companies in developing and executing cost-effective product development strategies. She has worked for several biotechnology companies, including two where she was a founder. She received a Bachelor's degree from Harvard University, a Ph.D. from the University of California, San Francisco, and performed post-doctoral research at the Dana-Farber Cancer Institute of Harvard Medical School.
About BioProcess Technology Consultants, Inc.
Founded in 1994, BioProcess Technology Consultants provides a full range of technical, business, and operations assistance to pharmaceutical and biotechnology companies in the development and commercialization of new biopharmaceutical products. The company specializes in helping clients to develop manufacturing processes and strategies, and assists in developing product discovery and process development programs that help speed products "from clone to clinic.™" BioProcess Technology Consultants also helps investors make informed decisions by providing technical and business evaluations of new products and technologies and of product discovery, development, and commercialization plans of potential investments and existing portfolio companies. For more about BioProcess Technology Consultants, visit http://bioprocessconsultants.com.
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BIOPROCESS TECHNOLOGY CONSULTANTS APPOINTS MAGIL CONSULTANT
ACTON, MA, May 16, 2005 -- BioProcess Technology Consultants, Inc., has appointed Sheila G. Magil, Ph.D., Consultant, focusing on product and method development, analytical technologies, and quality control.
“Sheila will strengthen our ability to provide clients with experienced CMC (Chemistry, Manufacturing and Control) management, and we are pleased to have her join us. As an experienced protein chemist, she has valuable expertise in the critical areas of analytical method development and formulation,” said Howard L. Levine, Ph.D., founder and president of the company.
Dr. Magil was previously senior manager at Biomeasure, Inc., in Milford, Massachusetts, where she headed the transfer of analytical methods and managed external analytical and quality control activities. She was also responsible for creating the Biologics Quality Control department. Prior to that, she held various positions in research, development, and quality control at Alkermes, Inc., Waratah Pharmaceuticals, Inc., and Bion Inc. As a development scientist at Alkermes, Dr. Magil worked on the formulation development of ProLease® form of human Growth Hormone as well as many other proprietary products. She was also Director of the Microchemical Facility at the Howard Hughes Medical Institute and the Massachusetts General Hospital overseeing protein and nucleic acid services provided to investigators at multiple institutions.
Dr. Magil holds a Bachelor’s degree in Chemistry from Carnegie-Mellon University and a Ph.D. in Biochemistry from the University of Minnesota.
About BioProcess Technology Consultants, Inc.
Founded in 1994, BioProcess Technology Consultants provides a full range of technical, business, and operations assistance to pharmaceutical and biotechnology companies in the development and commercialization of new biopharmaceutical products. The company specializes in helping clients to develop manufacturing processes and strategies and assists in developing product discovery and process development programs that help speed products from clone to clinic.™ BioProcess Technology Consultants also helps investors make informed decisions by providing technical and business evaluations of new products and technologies and product discovery, development, and commercialization plans of potential investments and existing portfolio companies. For more about BioProcess Technology Consultants, visit http://bioprocessconsultants.com.
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JAMES BLACKWELL JOINS BIOPROCESS TECHNOLOGY CONSULTANTS
ACTON, MA, April 18, 2005 -- BioProcess Technology Consultants announced that James V. Blackwell, Ph.D., has joined as a consultant, bringing more than 13 years of experience in manufacturing, cell culture and fermentation technologies, biopharmaceutical development, and commercial operations technical support.
"James is a key addition to the team and we’re delighted to have him join us. He has broad experience in process development and commercial technical operations, including in-depth knowledge of cell culture and fermentation. Our clients will benefit from his first-hand experience with several highly successful commercial products, and with tech transfer, quality, and regulatory issues," said Howard L. Levine, Ph.D., founder and president of the company.
Before joining BioProcess Technology Consultants, Dr. Blackwell was Senior Manager, Technical Operations at Abbott Laboratory’s Bioresearch Center in Worcester, MA. He headed site technical support of commercial operations, including for the bulk manufacturing of the arthritis drug HUMIRA®. Prior to that, he provided technical support for major commercial and clinical projects at Genzyme Corporation. As a research scientist at Genzyme and Repligen Corporations, Dr. Blackwell worked in the area of cell culture and fermentation process development. He is past president of the Greater Boston Chapter of ISPE, a society for pharmaceutical manufacturing professionals, and serves on its Process and Product Development Committee at the Society’s international level.
Dr. Blackwell holds Bachelor’s and Master’s degrees from The Ohio State University in Chemical Engineering and Microbiology, respectively; a Doctorate degree in Chemical Engineering from Northeastern University; and dual Master’s degrees in Business Administration and Technology Management from the University of Maryland.
About BioProcess Technology Consultants, Inc.
Founded in 1994, BioProcess Technology Consultants provides a full range of technical, business, and operations assistance to pharmaceutical and biotechnology companies in the development and commercialization of new biopharmaceutical products. The company specializes in helping clients to develop manufacturing processes and strategies and assists in developing product discovery and process development programs that help speed products from clone to clinic.™ BioProcess Technology Consultants also helps investors make informed decisions by providing technical and business evaluations of new products and technologies and product discovery, development, and commercialization plans of potential investments and existing portfolio companies. For more about BioProcess Technology Consultants, visit http://bioprocessconsultants.com.
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HOWARD L. LEVINE JOINS ADVISORY BOARD OF NEXBIO
SAN DIEGO, CALIFORNIA, and ACTON, MASSACHUSETTS, January 10, 2005 – NexBio, Inc., a biopharmaceutical company developing drugs to prevent and treat life-threatening human respiratory infectious diseases, and BioProcess Technology Consultants, Inc., have jointly announced the appointment of biopharmaceutical expert Howard L. Levine, Ph.D., to NexBio’s Advisory Board, joining three other internationally recognized experts. Comprising leading experts from academic centers of excellence and the pharmaceutical industry, the Advisory Board provides regular and critical review of NexBio’s product development plans.
President of BioProcess Technology Consultants, Inc., Dr. Levine has 25 years of experience in the biopharmaceutical industry. Dr. Levine and BioProcess Technology Consultants have assisted in the development and/or commercialization of more than 20 different biological products.
NexBio’s product development pipeline features the recombinant drug Fludase® to prevent and treat influenza infection. Mang Yu, Ph.D., CEO of NexBio, said, "We are honored to welcome Dr. Levine to our Advisory Board. His range of knowledge and experience in biopharmaceutical development and commercialization will be of great value in moving Fludase to the next stage of development after our already significant progress in demonstrating activity of the product in animal studies."
"It’s a pleasure to join NexBio’s team," said Dr. Levine. "The company’s use of recombinant technology to produce a novel drug for preventing and treating multiple strains of flu could have enormous healthcare impact. I’m excited about helping to speed it through development."
Prior to founding BioProcess Technology Consultants, Dr. Levine was Vice President of Manufacturing Operations at Repligen Corporation where he was responsible for all process development and manufacturing activities. He previously held positions of increasing responsibility in process development and manufacturing at Genentech, Amgen, and Xoma. Dr. Levine has authored over 20 papers on recombinant protein and monoclonal antibody development and lectures extensively on manufacturing strategy, process development, and operations in biotechnology. Dr. Levine is also on the Strategic Advisory Board of Acretia, Inc, and a member of the Editorial Advisory Boards of Bio/Pharmaceutical Outsourcing Report, BioPharm International, and BioProcess International.He is also co-editor of a directory of biologics contract manufacturers. Dr. Levine holds a Ph.D. in chemistry from the University of Chicago and completed a post-doctoral fellowship at Harvard University.
About NexBio, Inc.
Located in San Diego, California, NexBio is a biotechnology company developing novel, broad-spectrum prophylaxis and therapeutics for the prevention and treatment of life threatening human respiratory infectious diseases. It is developing Fludase® and Viracidin™ biotherapeutics to provide comprehensive protection against the influenza viruses at various clinical stages of infection. For more information about NexBio, please visit the company’s website at http://www.nexbio.com.
About BioProcess Technology Consultants, Inc.
Founded in 1994, BioProcess Technology Consultants provides a full range of technical, business, and operations assistance to pharmaceutical and biotechnology companies in the development and commercialization of new biopharmaceutical products. The company specializes in helping clients to develop manufacturing processes and strategies and assists in developing product discovery and process development programs that help speed products from clone to clinic.™ BioProcess Technology Consultants also helps investors make informed decisions by providing technical and business evaluations of new products and technologies and product discovery, development, and commercialization plans of potential investments and existing portfolio companies. For more about BioProcess Technology Consultants, visit www.bioprocessconsultants.com.
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