With the FDA tightening its guidance around the production of nonbacterial beta-lactam drugs, Swedish CDMO Recipharm is touting new efforts to stay in compliance—and a new partnership.
Juggling a mix of customer demand and new regulations, Recipharm says it has built out a new facility in Bengaluru, India, to produce nonbacterial beta-lactam tablets. The new plant has been designed to satisfy both U.S. FDA and European Medicines Agency standards, the CDMO explained in a Jan. 26 press release.
By commissioning the new facility, Recipharm says it has lassoed up a “major partnership” with an unnamed, “leading innovative biopharmaceutical company” to help produce the partner's nonbacterial beta-lactam tablets.
Under the partnership, Recipharm has further committed to install new specialized manufacturing capabilities at its Bengaluru site, noting that the expansion will not only help with its current team-up but could also service future collaborations around beta-lactam production, too.
Recipharm says it set to work on the new plant in response to final FDA draft guidance around nonbacterial beta-lactam drugs issued in June 2022. The new FDA standards instruct drugmakers to, among other measures, manufacture nonbacterial beta-lactam compounds in a way that fully eliminates the risk of cross-contamination with other products. The guidance hinges on safety concerns, as even “trace exposure” to the beta-lactam compounds can trigger allergic reactions in certain patients, Recipharm explained.
Concerns regarding beta-lactam cross-contamination came to the fore in September 2023 when Scynexis—which had enlisted in a licensing deal with GSK around its antifungal drug Brexafemme—revealed that a review of its manufacturing process by GSK triggered a recall of the drug and a pause of all clinical trials testing the medicine.
GSK’s concerns mainly came down to the fact that Brexafemme, approved to treat vaginal yeast infections, was manufactured on equipment that was also used to produce non-antibacterial beta-lactam drug substance, which can trigger hypersensitivity or allergic reactions in some people, according to a prior Scynexis securities filing (PDF). The FDA ultimately lifted a 19-month clinical hold on Brexafemme—tied to the beta-lactam production concerns—last May.
For its part, Recipharm did not go into specifics about the capacity its has brought online at the new plant or the amount invested in the facility.
“Regulatory change should not become a barrier to innovation or patient access,” Greg Behar, Recipharm’s CEO, said in a statement. “Our role as a CDMO is to adapt to our customers’ need and how the market is regulated. We evolve our manufacturing capabilities so our partners can focus on what matters the most to them: researching and developing new drugs.”
Recipharm boasts 17 facilities across nine countries, noting online that all of its international sites are equipped for manufacturing and development of drug substance, drug product and more innovative projects for advanced therapies.
The Bengaluru site features four large standalone facilities offering production for solid, semisolid and oral liquid dose forms, Recipharm explains on its website.