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BioProcess Technology Consultants Introduces Two Essential New Tools for the Biopharma Industry

bioTRAK® reports keep drug makers up-to-date on biomanufacturing capacity and products; new edition of book provides the latest on monoclonal antibody CMC and regulatory topics

Woburn, Mass., June 7 (Business Wire) – BioProcess Technology Consultants Inc. announces two important new products to help life science companies stay at the forefront of biomanufacturing trends and advances in product development: a subscription report series based on the extensive biomanufacturing information in BPTC’s proprietary bioTRAK® database, and a completely revised 2nd edition of BPTC’s earlier book on the development of monoclonal antibody products.

“The bioTRAK® report subscription series is unique in the industry,” said Thomas C. Ransohoff, vice president and principal consultant at BPTC, the leading provider of Chemistry, Manufacturing and Controls Services in the global life sciences industry. “The bi-annual reports included in this subscription product will help life science leaders stay current on worldwide biomanufacturing capacity, demand for manufacturing capacity for individual biopharmaceutical products, and industry trends that may impact overall capacity utilization.”

Each bioTRAK® subscription report includes:

• Biomanufacturing supply capacity statistics for mammalian cell culture and microbial fermentation facilities.
• Biomanufacturing capacity distribution by geography, number and size of bioreactors, facility status, and company type.
• Detailed analysis of demand for biopharmaceutical products, including development phase, product name, sponsor, type of molecule, and indication and estimated current and future manufacturing requirements for each.

Samples of the most recent bioTRAK® subscription report and subscription terms will be available at BPTC’s booth #1124 in the Bio Process Zone within the BIO Exhibition Hall at BIO 2017 in San Diego from June 20-June 22.

BPTC also announced the publication of the second edition of its indispensable book, “The Development of Therapeutic Monoclonal Antibody Products: A Comprehensive Guide to CMC Activities from Clone to Clinic.”

This newly expanded and updated book provides an in-depth review of the critical CMC activities necessary to successfully develop monoclonal antibody products. The book includes sections on Quality by Design, new perspectives on cell line development and engineering, and a fresh look at process validation in line with current regulatory practice. The book is edited by Howard L. Levine, Ph.D., president and CEO and Brendan Cooney, associate consultant of BPTC, and includes contributions from BPTC consultants recognized as experts in monoclonal antibody development.

“‘The Development of Therapeutic Monoclonal Antibody Products’ is essential reading for biotech executives from the C-suite to senior operations personnel,” said David de Graaf, Ph.D., president and chief executive officer of Syntimmune, a clinical stage biotechnology company developing antibody therapeutics for a variety of autoimmune diseases. “It gives a clear, concise, and authoritative overview of the many CMC challenges that must be addressed to produce an antibody treatment that will meet regulatory muster and advance through clinical trials to ultimately help patients. Our regulatory and production team, comprised of leaders in the development of antibody therapeutics for autoimmune disease, refers often to this book.”

“BPTC is to be applauded for this new, expanded edition of ‘The Development of Therapeutic Monoclonal Antibody Products,’” said Anthony J. Sinskey, Sc.D., professor of microbiology and engineering systems at the Massachusetts Institute of Technology and co-founder of several biotechnology companies, including Genzyme. “In addition to providing companies with useful information that will enable them to speed their drug candidates through the many chemistry and manufacturing issues that will arise on the road to commercialization, the book will be an invaluable reference and teaching tool for those new to the field of monoclonal antibody development.”

To preview the book or to order your copy, please visit http://www.bptc.com/product/development-therapeutic-monoclonal-antibody-products/. In conjunction with the upcoming BIO industry conference, BPTC is also announcing a 10% discount to those who purchase the book before July 31, 2017. To obtain a coupon for this limited time offer, visit BPTC’s booth #1124 in the Bio Process Zone within the BIO Exhibition Hall at BIO 2017 in San Diego from June 20-June 22.

About BioProcess Technology Consultants

Founded in 1994, BioProcess Technology Consultants is the recognized worldwide leader in biologics Chemistry, Manufacturing, and Controls (CMC) consulting, providing a full range of technical, regulatory, and strategic assistance to pharmaceutical and biotechnology companies in the development and commercialization of biopharmaceutical products. The company works with clients globally to find and apply solutions to the challenges of biopharmaceutical product development from clone to commercial®. BPTC helps develop manufacturing processes and strategies that enhance the overall value of client companies and accelerate the advancement of new products from clone to clinic®. BPTC 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 information about BPTC, visit http://www.bptc.com. Follow us on Twitter at @bptcGlobal and LinkedIn at https://www.linkedin.com/company-beta/510782.