Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider.

Featuring: Dr. Ger Brophy, Executive Vice President, Biopharma Production, Avantor.

Avantor has expanded its biopharmaceutical capabilities significantly over the past year. In addition to opening facilities in The Netherlands and Massachusetts for manufacturing and distribution of single-use systems, respectively, the company has broken ground on sites in Ireland and Singapore. Avantor also acquired Masterflex, a manufacturer of peristaltic pumps and fluid-handling solutions.

Brophy explained that such activity exemplifies Avantor’s efforts to increase the resilience of its supply chains. Even before the COVID-19 pandemic, companies in many industries recognized the need to invest in regional centers for manufacturing and distribution. Pandemic-related supplychain disruptions compelled biopharmaceutical vendors to accelerate their expansion projects. For instance, Avantor hastened plans to secure additional pathways for raw material inputs, establish redundant manufacturing capacity in multiple regions, and evaluate capital investments.

When asked about whether COVID-related expansions would create overcapacity, Brophy noted that significant needs remain for SARS-CoV-2 vaccine manufacturing, particularly for low and middle-income countries. Thus, vaccine companies continue to order bioproces consumables in large volumes. Brophy expected high demand to persist for the foreseeable future. Demand also is strong for components related to production of monoclonal antibodies (MAbs) and other “traditional” biologics despite capacity diversions for mRNAbased products and increasing interest in advanced therapies.

Brophy noted that Avantor has established new facilities in different regions, in part, to address diverse customer needs quickly and flexibly. It also is introducing products designed for emerging therapeutics. He highlighted his company’s new reagent for lysis of HEK293 cells used in gene therapy applications. Avantor’s partnership with GeminiBio similarly seeks to provide gene therapy developers with custom hydrated solutions and cell culture media.

Brophy expected demand for cell and gene therapies to increase despite recent diversions of funding and capital to research and development (R&D) for therapies based on mRNA, antisense oligonucleotides (ASOs), and RNA interference (RNAi). He cited US Food and Drug Administration (FDA) approval of Yescarta (axicabtagene ciloleucel, Gilead), a chimeric antigen receptor (CAR) T-cell therapy, as a second-line treatment for large B-cell lymphoma. CAR-T and gene therapies finally are gaining clinical acceptance, Brophy explained. That development will bolster candidate advanced therapies in the clinical pipeline and influence subsequent regulatory approval processes.

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