Manufacturing

Lupin has agreed a “long-term strategic alliance” with CDMO PolyPeptide that the firm says will bolster its supply chain for peptide APIs.

Industry warns healthcare infrastructure – not manufacturing – may be the real bottleneck as cell therapies eye mass-market diseases.

“There's a lot of third-party audit information out there. Could we take that and apply it into our inspectional planning process?” says Office of Dietary Supplement Programs Director Cara Welch.

After years of regulatory setbacks, Amphastar has secured FDA approval for its first pen device combination product, targeting a $585m Forteo market.

Sandoz said it was “asserting biosimilars leadership” as it announced the completion of a deal to acquire Just-Evotec Biologics’s Toulouse development and manufacturing site as well as an indefinite licence to the firm’s continuous manufacturing technology.

Cuban argues that user fees under the GDUFA program are deterring domestic production of generics, according to reports.

Partnership aims to improve yields, cut development time, and bring data-driven control to bioprocessing.

FDA says Teresa Michele, in CDER nonprescription drugs program leadership roles since 2013, was being moved to another position in the agency.

Cellafa Bioscience, an Astellas-Yaskawa joint venture, uses Maholo robotic automation and AI to standardize cell therapy manufacturing, targeting GMP compliance within two years and global expansion.

In an exclusive interview, Generics Bulletin spoke to a trio of experts who argue that biosimilar cell and gene therapies are technically within reach but demand unprecedented regulatory clarity, manufacturing evolution and economic alignment before they become reality.

Executives leading the commercialization of cell and gene therapies are informing how the industry approaches everything from manufacturing strategy to physician education.

During the first GDUFA IV negotiation session, industry representatives were unsure whether the FDA’s idea to create pathways for onshoring incentives fit the scope of the generic drug user fee program.