--- title: 'Manufacturing Daily Summary: What Happened on November 2, 2026' headline: Drug sponsors remain accountable when manufacturing is outsourced description: European biotech companies are weighing integrated contract services against specialist providers. Product-level life-cycle data could also inform sustainability choices in oral drug delivery. url: https://thebench.bio/news/manufacturing/2026-11-02 topic: manufacturing date: '2026-11-02' covers: - '2026-11-02' date_published: '2026-11-02T12:02:11Z' date_modified: '2026-11-02T12:02:11Z' tags: - Industry - Manufacturing sources: 2 publisher: TheBench.Bio --- # Manufacturing Daily Summary: What Happened on November 2, 2026 **Drug sponsors remain accountable when manufacturing is outsourced** European biotech companies are weighing integrated contract services against specialist providers. Product-level life-cycle data could also inform sustainability choices in oral drug delivery. ## 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] ## The day in numbers - **CHF 1.46 billion**: Samsung Biologics’ cash bid for PolyPeptide. [1] - **CHF 2.3 billion**: Enterprise value of Lonza’s Capsules & Health Ingredients division transaction. [1] - **40%**: Lonza’s retained ownership stake in the division. [1] ## Sources 1. [Europe ­rethinks the CRO-CDMO model](), European Biotechnology, 2026-11-02 2. [Making oral drug delivery more sustainable with measurable product-level data](), PharmaVoice, 2026-11-02 --- TheBench.Bio wrote this from the reporting cited above, with a language model drafting and editing. [1]: [2]: