Biotech manufacturing news summary, 2

Today in brief

Xspray Pharma disclosed another FDA rejection of its HyNap-Dasa application, after the agency cited unresolved observations at contract manufacturer NerPharMa.1 The company said the FDA had not questioned the clinical data, bioequivalence or stability, and that responsibility for resolving the observations rests with NerPharMa’s new owner, Benta Group.1

Outsourcing leaves sponsors accountable for manufacturing quality

The FDA rejected Xspray Pharma’s HyNap-Dasa application in 2023 and 2024, citing dosing information, label comprehension and manufacturing-site issues.1 In October 2025, the agency issued another complete response letter citing manufacturing practice observations at NerPharMa, the contract manufacturer responsible for HyNap-Dasa.1

On August 19, 2026, Xspray disclosed another rejection, with the FDA citing outstanding site observations and requesting data from additional consecutive commercial-scale batches.1 Xspray said the observations did not involve the production line used for its product and that the FDA had not questioned clinical data, bioequivalence or stability.1 The company said resolving the observations now falls to NerPharMa’s new owner, Benta Group.1

Sponsors remain responsible for manufacturing quality and reliability when contractors do the work.1 Cornelius Klöck says dividing connected manufacturing steps among providers can cost teams context and blur accountability.1 Martin Krauss says using too many specialists adds interfaces, while relying heavily on one provider can limit flexibility and create dependency.1

Companies use different outsourcing models: FGK keeps core clinical development in-house, while Rentschler uses Coriolis Pharma for formulation and Vetter for aseptic filling.1 Rezon Bio says it separated its contract development and manufacturing organization business from its biosimilar pipeline to avoid competing with clients.1 Its Warsaw-Duchnice site received FDA approval for commercial biosimilar manufacturing in February 2026.1

Samsung Biologics made a CHF 1.46 billion cash bid for PolyPeptide.1 Lonza agreed to sell control of its Capsules & Health Ingredients division to Lone Star Funds at an enterprise value of CHF 2.3 billion, while retaining a 40% stake.1 The transaction is expected to release CHF 1.7 billion for growth, acquisitions and share repurchases.1

Also worth knowing

Auditable life-cycle assessment data could help guide sustainability decisions for oral drug delivery, according to a PharmaVoice article.2