BioProcess Technology Consultants

EXPERIENCE

BioProcess Technology Consultants is the recognized world leader in biologics CMC consulting on technical, business, and strategic matters. We have helped clients bring their product candidates from research into clinical trials and have provided expertise in the commercialization of more than 10 different licensed biologic products.

CLIENTS
The company has served hundreds of clients for projects ranging from early stage discovery research through development and commercialization. We value our client relationships and are pleased to continue to work with many of our original clients.

Our clients include:

Pharmaceutical companies
Start-up biotechnology companies
Virtual companies
Development organizations
Large and multi-national companies
Discovery companies with no development expertise
Investment banks and venture capitalists
Professional organizations
Vendor and service companies
Commercial Real Estate companies

With the increasingly global nature of the biopharmaceutical industry, our work extends worldwide. Our consultants have served clients in Europe, the Middle East, the Far East and Pacific Rim countries, India and Canada.

Technologies and Services
Our technical, operational, quality, and regulatory experience ranges
from expert technical input on specific issues to oversight and management of entire manufacturing development programs; and from bulk drug production from a recombinant host to labeling and distribution to the clinical trial sites. We have written multiple regulatory submissions, including INDs, IMPDs, BLAs, MAs, and others.

We have had extensive experience with technologies and products that include:

Antibodies
Recombinant proteins
Peptides- natural and synthetic
Oligonucleotides
Gene and cell therapy
Conjugates
Natural products
Vaccines
Biotherapeutics in medical devices
Diagnostics

BioProcess Technology Consultants has executed numerous projects entailing due diligence (technical, business, and compliance) and market and cost analysis of technologies, companies, programs, and products. The company has also assisted leading companies in the marketing and value utilization assessments of manufacturing facilities.

In addition, BioProcess Technology Consultants has helped leading operational companies achieve greater success and efficiencies in their CMC activities and supply chain by helping them to achieve proper organizational alignment with strategic and tactical objectives and by assisting with formulation of focused and practical CMC strategies and tactics.