The trend towards outsourced buffer manufacturing in biopharmaceuticals

Buffers, the compounds or compound mixtures used to control pH in drug manufacturing, are a vital component to maintain the stability of both small molecule and biologic drugs during production and in their final form. Today, with rising interest in cell and gene therapies (CGTs) for diseases ranging from cancer to inherited diseases, and the growing need for the manufacturing of vaccines. Biopharmaceutical companies are increasingly looking to outsource the development and production of buffers for both their drug development programs and therapeutics manufacturing.

Whether constrained by physical space, requirements for higher titers, lack of resources, or a preference for lean operations, the economics of make-v-buy when it comes to buffers is leaning to buy. Growth in CGT, as well as changes in the small molecule market, have made the production and use of buffers more specialized and more challenging. As a result, large and small biopharmaceutical companies alike are increasingly relying on third parties to source their buffers.