Large Molecule / QRM Tools

Biomanufacturing Consortium

By Karen Langhauser, Chief Content Director

Mar 07, 2016

Launched in 2013, National Institute of Standards and Technology’s (NIST) Advanced Manufacturing Technology Consortia (AMTech) program is a competitive grants program intended to establish new or strengthen existing industry-driven consortia that address high-priority research challenges impeding the growth of advanced manufacturing in the United States.

Considering about one in every four drugs introduced to the market is a biopharmaceutical, a key consortium in this program is the Biomanufacturing Science and Technology Consortium. Launched in June 2015, the two-year BSTC project brings together industry, government and academic leaders to develop a dynamic technology roadmap for the biopharmaceutical manufacturing industry’s challenges of improving quality and safety of biopharmaceuticals and securing significant cost savings.

The development of the biomanufacturing consortium will foster and support the fast-growing biopharma industry and the sustained leadership of the U.S. in that area. It is imperative to have a consortium of leaders to spearhead a “roadmap” for next-generation technology that will help to ensure future growth and stability of the industry. Regional meetings will be organized by the consortium in order to bring together leading experts to:

• Discuss the challenges and driving factors in upstream and downstream biopharmaceutical processing

• Identify the major technological, operational and regulatory barriers in biopharmaceuticals

• Develop a technology roadmap for biomanufacturing industry’s next generation

• Define a pre-collaborative workspace for companies, academia and regulatory authorities

Through a workshop-guided effort, the consortium aims to lay the foundation for a sustained partnership among the members that will foster U.S. competitiveness in the global market. Major participants include: Biogen, Genzyme, Shire, Genentech, Lonza, GSK, GE, EMD-Millipore, MLSC, Pfizer and Quincy College.

According to AMTech, “Without a roadmap, the industry’s current challenges cannot be transformed, innovative biomanufacturing systems cannot be pioneered, new technological standards cannot be set, and sustained global leadership of the U.S. biomanufacturing industry cannot be guaranteed.”