The Situation We Faced: Aaron Cowley, CSO, Recipharm Advanced Bio, Discusses Vision to Cut Biomanufacturing Timelines, Transform Continuous Manufacturing

A unified field theory for Process Analytic Technologies (PAT) from Recipharm Advanced Bio seeks to disrupt the traditional off-line analytics testing and manual data entry systems. These systems currently cost the industry precious time, and between $6 billion to $8 billion dollars in 2025 spending figures (of an approximately $13 billion total addressable market for PATs).

Recipharm Advanced BIO is spinning out a new corporate structure, looking to raise investment funds, just-in-time for the JP Morgan Healthcare Conference. This is founded on a close relationship with FDA and a pilot proof of concept initiative housed at MIT, which itself was based on an earlier continuous manufacturing process pilot partnership between MIT, FDA, and Novartis.

The "Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century--A Risk Based Approach" initiative was announced by the FDA in August 2002 to improve and modernize pharmaceutical manufacturing-facilitated adoption of process analytical technology by the pharmaceutical industry.¹

Fast forward to April 2023 and FDA, in an unusual move,plunked down $82 million to spur development of a continuous manufacturing process for mRNA drug products, to better prepare for future pandemics.

“Arranta Bio, part of Recipharm’s biologics business, has signed a contract with MIT to develop a continuous manufacturing technology for mRNA therapeutics. The contract is part of the FDA’s initiative to have a fully integrated, continuous manufacturing production line for mRNA vaccines, which the agency is funding through a contract to MIT—one of the largest awards from the FDA’s CBER office. Enabling rapid manufacturing capacity will provide faster readiness and reaction to new pandemic threats.”²

Peter Marks, head of FDA’s CBER at that time, said that in relation to mRNA developments post Covid-19—and why there was the need for a new advocacy group, such as the Alliance for mRNA medicines (AMM)—he noted that “When a group such as [AMM] is formed, it floats all boats,” but he particularly emphasizes, “it’s very helpful to have a single unified voice to streamline engagement of expert working groups, build consensus, and relay authoritative guidance, fundamental facts (and constraints), to both the general public and also the pertinent governmental agencies. I look forward to regular working discussions with AMM—and other participants—in this field.”³

So having a single unified PAT system deployed all around the globe, is clearly something of high utility for not only the FDA, but as it turns out, the Gates Foundation, whose mission is to help provide the same quality standards of healthcare and medicine no matter where you are on the globe. The Gates Foundation has also financially supported this initiative.

According to Cowley in this discussion, their team has been able to “dramatically reduce the number of expert team members needed to test and release biological modalities, reduce process development timelines, manufacture and release timelines by up to 50%, heading in the near future to the neighborhood of 70% for some modalities.”

Sources

1. Rathore, A, Bhambure, R, Ghare, V, Process analytical technology (PAT) for biopharmaceutical products, Anal Bioanal Chem, May 2010
2. Arranta Bio, A Recipharm Company, Signs Contract With MIT To Develop Rapid Manufacturing Of mRNA Therapeutics, April 2023, OutSourced Pharma
3. Spivey, C, Government gets its arms around advanced therapy medicinal products early: government provides a spoonful of sugar, and genuine leadership, for good medicines, biopharma International August 2023, MJH Lifesciences.