Advances in Large-Scale Biopharmaceutical Manufacturing and Scale-Up Production (2nd Ed)

Summary

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This is the second edition of our extensive research into current advances in biopharmaceutical manufacturing and scale-up production. It has been updated as a result of requests from the industry to ensure a single resource that tracks and presents trends in this fast-changing scientific area. The study was undertaken, managed and coordinated by BioPlan Associates, Inc., a biopharmaceutical management and marketing research consulting firm in Rockville, MD, based on its 18 years experience and knowledge of the market segment. BioPlan surveyed the industry to identify required content, and then selected subject matter experts to author relevant chapters for this study.

The American Society for Microbiology, in recognizing the importance of applied sciences in biotechnology processes, has lent its name to this endeavor. ASM's mission is to promote research and research training in the microbiological sciences and to assist communication between scientists, policy makers, and the public to improve health, protect the environment, and foster economic well-being. This study provides a platform from which both basic and applied research scientists can share findings and novel technologies associated with biopharmaceutical manufacturing. The findings of this report may also support public, health and economic policy.

Each chapter provides a unique, unbiased view of the current state of the science and technology associated with biopharmaceutical manufacturing and scale-up production. While no single body of work can encompass all the advances being made in the field, this work offers the most comprehensive information to date on technologies and processes that will be leading the next decade.

Included are sections on biopharmaceutical manufacturing technologies for human therapeutics, including mammalian, microbial, and yeast systems, and other novel technologies. We have evaluated the entire production process, from early scale-up through purification and downstream production. Each chapter includes extensive technical information and quantifiable data, as well as including real-world situations and relevant case studies that provide context for the discussions.

The intended audiences are decision-makers at biopharmaceutical organizations, contract manufacturing organizations, suppliers to the industry, and international entities evaluating this market. As the industry progresses, we plan to keep this study current by providing regular updates as technologies evolve.

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