Supplier news: Siegfried, Vetter, Made Scientific & more. The latest from cdmos, cmos, and suppliers featuring Siegfried, Vetter, Made Scientific, OrganaBio, Thermo Fisher Scientific, Piramal Pharma Solutions, Hovione, Andelyn Biosciences and Avid Bioservices. Chemicals/Chemical API Manufacturing Siegfried Completes Acquisition of Noramco, Extractas Biosciences Siegfried, a CDMO of drug substances and drug products, has completed its previously announced acquisition of three drug-substances sites of Noramco, Extractas Biosciences, and Purisys (a Noramco subsidiary) from affiliates of the private-equity firm, SK Capital Partner. The acquired businesses include three small-molecule drug-substances sites with approximately 400 employees. The acquisitions included: (1) Noramco's commercial-scale manufacturing site in Wilmington, Delaware; (2) Purisys' clinical active pharmaceutical ingredient (API) development and manufacturing facility in Athens, Georgia; and (3) Extractas Bioscience, a manufacturer of purified products based in Westbury, Tasmania, Australia. Following the closing, SK Capital retains ownership of Halo Pharmaceuticals, a CDMO of drug products purchased by Noramco in 2023. Going forward, Lee Karras and Alan Majewski, CEO and CFO, respectively, of the Noramco Group, will remain with Halo Pharmaceuticals and continue to lead the business in their current roles. Piramal Pharma Solutions Opens ADC Suite Piramal Pharma Solutions, a CDMO of active pharmaceutical ingredients and drug products, has opened a new payload-linker development and manufacturing suite at its Riverview, Michigan drug-substance facility. The launch is a key element of the company's broader $90-million investment plan to extend US-based manufacturing capabilities, announced in 2025. In addition to the payload-linker suite, the plan will add new technology and enhanced commercial-scale manufacturing capabilities at the company's dedicated sterile injectables facility in Lexington, Kentucky. Biologics Manufacturing Made Scientific, Roosterbio Partner for Stem-Cell Mfg Made Scientific, a Princeton, New Jersey-based cell-therapy CDMO, and RoosterBio, a supplier of human mesenchymal stem cells (MSCs), engineered bioprocess media, and bioprocess development services, have announced a strategic partnership integrating RoosterBio's MSC and extracellular vesicle (EV) manufacturing platforms into Made Scientific's CDMO service offering, which spans from initial process development through commercial-scale GMP manufacturing. Under the agreement, Made Scientific will incorporate RoosterBio's off-the-shelf MSCs, proprietary MSC expansion and EV collection media across its GMP operations. Organabio Acquires Excellos OrganaBio, a manufacturer of GMP cells and blood products and provider of cell isolation and cryopreservation services, has acquired substantially all of the operating assets of San Diego-based Excellos to create a cell-therapy CDMO. Newly formed OrganaBio subsidiary Excellos Labs will be responsible for San Diego operations going forward. The company's combined platform consists of multiple facilities across the US. OrganaBio's Miami headquarters anchors the East Coast with adult leukapheresis (via its HemaCenter subsidiary), birth tissue and cord blood sourcing (via its GaiaGift subsidiary), ISO 7 cGMP cleanrooms, process development, QC/analytical testing, PBMC isolation, and cryopreservation. On the West Coast, OrganaBio operates cell-processing and cryopreservation labs in San Francisco and Irvine, California, and now adds Excellos' downtown San Diego facility, with five ISO 7 cGMP cleanroom suites supporting autologous and allogeneic cell-therapy manufacturing, cell isolation and enrichment, expansion, and fill-finish. Thermo Fisher Launches Cell-Therapy Mfg Platform Thermo Fisher Scientific has launched its new Gibco CTS DynaXS single-use bioreactor, an expansion platform designed to help cell-therapy developers scale manufacturing. Andelyn Biosciences Launches Lentiviral Vector Mfg Platform Andelyn Biosciences, a CDMO of cell and gene therapies, has announced the launch of its LVV curator platform, a standardized lentiviral vector (LVV) manufacturing solution built on the same modular approach that supports clinical and commercial adeno-associated virus (AAV) programs. Formulation Development/Drug Product Manufacturing Vetter Breaks Ground on New Injectable Mfg Facility Vetter, a CDMO of drug product development, clinical, and commercial aseptic filling and packaging, has started construction on its new site in Saarlouis, Germany. During the first construction phase, the company will build a facility for the commercial production of injectable drugs on the 95-acre industrial site. In total, Vetter will invest almost half a billion euros in the site by the planned commissioning in 2031. Once operational, the facility will create 400 to 500 new jobs. In the first expansion phase, Vetter will build a 50,000-square-meter manufacturing site, along with production-related facilities including laboratories and warehouses. Initially, three cleanrooms are planned for the aseptic production of innovative and complex drug products: two for filling pre-sterilized syringes and one for filling vials. Hovione Announces Leadership Transition, Interim Co-CEOs Hovione, a CDMO of drug substances and drug products, reports that Jean Luc Herbeaux, the company's Chief Executive Officer (CEO), will be stepping down from his role as CEO for personal reasons, effective May 21, 2026. He will continue with the company until September 30, 2026, to facilitate a smooth transition The company's Board has initiated a succession process to appoint the company ́s new CEO. In the interim, the Board has appointed António Almeida, currently Chief Financial Officer, and Dr. Marco Gil, currently Senior Vice President, Sales & Marketing) as co-Chief Executive Officers, effective May 21, 2026. Separately, Hovione and Industrial Design Consultancy (IDC), a global product development company, have announced that their intranasal drug delivery platform has reached a new milestone, with its lead single-use nasal dry-powder device available for commercial partnerships. The companies have completed the device design and established initial device manufacturing and supply capability, Appointments Avid Bioservices Names New Chief Commercial Officer Avid Bioservices, a biologics CDMO, has announced the appointment of Kerri McCullough Wood, formerly Chief Commercial Officer at TAPI, a division of Teva, as Chief Commercial Officer. She is a seasoned biopharma executive with nearly three decades of experience across API, CDMO, and drug-product services. She joins Avid following her role as Chief Commercial Officer at TAPI, where she led a global organization spanning 15 countries and was responsible for executing commercial strategy, accelerating growth initiatives, building strong partnerships with global pharmaceutical companies, and enhancing organizational performance across the business.

Cell therapy weekly: UK MHRA launches gene therapy consultation. 14 May 2026 This week: The UK's Medicines and Healthcare products Regulatory Agency (MHRA; London, UK) has launched a nationwide consultation to modernize gene therapy regulation, OrganaBio LLC (FL, USA) has acquired Excellos Inc.'s (CA, USA) operating assets and Fractyl Health, Inc. (MA, USA) has received Clinical Trial Application authorization in the Netherlands to initiate a Phase I/II study of a gene therapy for type 2 diabetes. The news highlights: UK MHRA launches gene therapy consultation. In partnership with Northern Ireland's Department of Health (Belfast, Northern Ireland), the UK MHRA has launched a consultation to update the legal definition of gene therapy medicinal products, which has remained unchanged for over a decade. The proposed changes aim to modernize the definition to reflect recent advances in gene therapy, synthetic biology and gene editing by classifying products based on mechanism of action rather than outdated criteria. The update will not alter approval processes, affect licensed products or change safety standards, but it will provide greater regulatory clarity, ensure consistent regulation across biologically and synthetically created therapies, and support innovation. "This proposal reflects how fast-paced scientific progress can be and ensures our regulatory framework remains robust, clear and fit for the future," commented MHRA Deputy Director InnovativeMedicines Jon Beaman. "Our teams have carefully designed these updates to ensure that patient safety remains at the center of any change, while also giving developers, researchers and clinicians greater regulatory certainty, while supporting innovation across the industry." The consultation, running from 11 May-22 June 2026, primarily targets developers, manufacturers, researchers, regulatory professionals and clinical experts, though anyone may respond. It seeks feedback on five key proposals: * Removing the requirement for gene therapies to be biological in origin * Clarifying when synthetic or recombinant nucleic acids fall within scope * Ensuring sequence-specific genome-editing products are regulated as GTMPs * Maintaining the exclusion of infectious disease vaccines from GTMP definitions * Proposing updates to the Human Medicines Regulations 2012 to support these changes Formation of a comprehensive cell therapy service provider. OrganaBio has acquired substantially all the operating assets of Excellos, creating a bicoastal cell therapy contract development and manufacturing organization that combines complementary capabilities and expands geographic coverage to deliver more comprehensive cell therapy services. The newly formed Excellos Labs, LLC will oversee San Diego operations going forward. "This acquisition is the best of both worlds, ensuring continuity for Excellos' customers as we move into our next phase while adding critical redundancy, expanded geographical reach, and access to additional services and material including cord blood," explained Tom VanCott, CEO of Excellos. First gene therapy to enter clinical development for type 2 diabetes. Fractyl Health, Inc. has received Clinical Trial Application authorization in the Netherlands to begin the Phase I/II first-in-human study of RJVA-001, marking what the company believes is the first adeno-associated virus-based gene therapy to enter clinical development for type 2 diabetes. RJVA-001 is a one-time, beta-cell-targeted gene therapy designed to enable nutrient-responsive GLP-1 expression within the pancreas through a minimally invasive endoscopic infusion, potentially avoiding the high drug levels and side effects associated with systemic GLP-1 therapy. "For decades, we have managed [type 2 diabetes] as a chronic, progressive disease that inevitably worsens over time. With this authorization, we are preparing to test, for the first time in humans, whether a one-time, pancreas-targeted gene therapy delivered via a routine endoscopic procedure could provide durable metabolic control by enabling physiologic, nutrient-responsive GLP-1 expression at the source of disease," elaborated Jacques Bergman, Principal Investigator of the RJVA-001 first-in-human study. "Patients who remain inadequately controlled despite maximally tolerated GLP-1 receptor agonists (GLP-1RAs) and multiple oral agents represent a population with significant unmet need. If successful, RJVA-001 could transform how we think about [type 2 diabetes], from a chronic disease you manage every day to one that could potentially be treated once." The open-label, multicenter study will evaluate safety, tolerability and efficacy in adults across three escalating dose cohorts (three participants in each cohort), with an optional expansion cohort of up to 20 additional participants. Participants will undergo 12-month monitoring for safety, glucose control, immune response and GLP-1 expression, followed by long-term follow-up for up to 5 years.

OrganaBio, a Miami-based manufacturer of GMP cells and blood products, has acquired substantially all operating assets of San Diego-based Excellos to create a bicoastal cell therapy contract development and manufacturing organisation. Financial terms were not disclosed. The acquisition establishes coast-to-coast operations spanning multiple US facilities. OrganaBio's Miami headquarters anchors East Coast operations with leukapheresis, birth tissue sourcing, ISO 7 cGMP cleanrooms and analytical testing. West Coast operations now include cell processing labs in San Francisco and Irvine, plus Excellos' San Diego facility featuring five ISO 7 cGMP cleanroom suites. The combined platform serves many of the top 20 global pharmaceutical companies and numerous biotechnology developers, supporting cancer and autoimmune therapeutic programmes. Full integration is expected within 12 months whilst maintaining existing operations for all customers.