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SPECIAL REPORTS
BioProcess Technology Consultants offers unique, actionable information resources for the biopharmaceutical industry. The insightful analysis in our reports is designed to help decision makers build and put to work comprehensive business and technical strategies for the complicated topics covered. Browse the Table of Contents for each report to see how it can help your company.
The Development of Therapeutic Monoclonal Antibody Products
Now Available
The report provides a detailed analysis of the technical and regulatory requirements necessary to successfully develop therapeutic monoclonal antibody products from discovery through first-in-man clinical trials and also gives an overview of the strategic and regulatory considerations for late-stage development and commercialization of these products, including a detailed discussion of such important issues as process validation, Quality by Design, manufacturing economics, and the risks and benefits associated with the use of platform processes.
Regulatory Compliance Guide Series (GxP Guides)
Available February 2010
This three-part series, Good Manufacturing Practice, Good Laboratory Practice, and Good Clinical Practice, provides clear recommendations for full compliance with the global regulatory requirements. The series includes templates for SOPs and other forms that can be copied and used directly. Each guide includes chapters and appendices covering:
Summary of the Regulatory Compliance Guide Series
Mammalian Cell Culture Supply and Demand Report
This report provides an extensive analysis of the supply/demand balance of the mammalian cell culture market, forecasting demand and supply requirements from 2008 to 2014, and summarizes the key drivers and variables for this capacity.
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