Biotech Manufacturers Explore Global Access and Supply Chain Hurdles

Industry is joining with academia and global health leaders to examine new approaches to biotech manufacturing that can help expand access to important therapeutics around the world. A Global Health Initiative involving collaboration between CASSS, the separations society, and the Massachusetts Institute of Technology Center for Biomedical Innovation (MIT–CBI) will explore new technologies and production approaches with potential to ensure a reliable and sustainable supply of affordable vaccines and therapeutics to treat diseases prevalent in developing countries.

At a workshop sponsored by MIT–CBI and CASSS during the WCBP Symposium in Washington, D.C. in January 2016, participants examined factors limiting third-world access to biotech products and innovations likely to overcome these roadblocks. Steve Hadley of the Bill and Melinda Gates Foundation discussed how projected demand for treatments in all regions are overwhelming current manufacturing capacity, illustrating the need for more productive cell cultures able to produce high volumes of low-cost drug substances. Gates is investing in the development of high yield cell lines, innovative fill-finish technologies, and mRNA vaccines, and in projects to establish platforms for low-cost monoclonal antibodies (mAbs) and alternative host production.

Dean Pettit, founder of Just Biotherapeutics of Seattle, described efforts to use product engineering and in-silico techniques to design biotherapeutics that not only demonstrate clinical activity, but also manufacturability and affordability. The firm is involved in designing a low-cost science park in China and is collaborating with Gates and with Merck to develop new biotherapeutics manufacturing processes that will support broader access to crucial protein therapeutics.

Difficulties in ensuring sustainable supplies in less developed regions of essential biologics, such as clotting factors to treat Hemophilia A, require new manufacturing approaches that optimize production, explained James Leung of CBI–MIT. Leung noted that product prices are only one part of the sustainable access issue, and that costs to supply and administer products to patients also are crucial factors in ensuring sustainable supplies.

The session, which was co-chaired by John Frenz of Alnylam Pharmaceuticals, recently named president of the CASS Board of Directors, and William Hancock of the Barnett Institute at Northeastern University, stimulated discussion about how CASSS could work with CBI–MIT to address global biopharmaceutical needs. A key issue is the viability of distributed vs. centralized manufacturing systems. This assessment may be affected by manufacturing knowledge, compliance requirements, cold-chain infrastructure, and potential impact of new technology. Workshop participants noted that a range of political factors, such as government price controls on vaccines or the ability of local manufacturers to comply with international standards, are important in weighing the risks and benefits of different production models. 

A collaborative group from CASSS and MIT plans to further examine these and other issues related to global access to biologics with an eye to mapping out a plan for action. Specific topics are technology needs, reliable raw material supplies for local manufacturing, and whether there are sufficiently reliable and cost-effective quality manufacturing systems around the world able to provide formulations that fit current supply chain and delivery system requirements.