Global CDMO Update

U.S. CDMO Updates:

• SK pharmteco to Expand Capabilities with Acquisition of Controlling Interest in Center for Breakthrough Medicines, the announcement is less than two years after an initial $350 million capital investment in 2022 and comes on the heels of SK pharmteco’s acquisition of Yposkesi, a French viral vector CDMO, in March 2021. Once the new deal is finalized, SK pharmteco will have a controlling stake in CBM, and the operations of CBM will be integrated with Yposkesi to establish a global CGT business unit with unprecedented capabilities and capacity (PR)

• MilliporeSigma Invests $25M to Expand Cell Culture Media Production in Kansas by 98,000sf. Cell culture media is an essential raw material used in the manufacture of therapies and in processes for vaccines, gene therapy, and mAb manufacturing. (genengnews)

• Lonza and Vertex Celebrate the groundbreaking of the Cell Tx Manufacturing Facility on Lonza’s campus in Portsmouth, NH. The large-scale facility is a co-investment of both companies and it will support the development and commercialization of the Vertex type 1 diabetes cell therapy portfolio. Operated by Lonza, the 130,000sf facility will employ 300 employees at peak capacity, in areas including manufacturing operations, quality assurance, and quality control. (PR)

• Senti Bio extends cash runway through a $38m sublease deal with GeneFab – a newly formed CDMO backed by private equity firm Celadon Partners. The company’s former chief technology officer and co-founder Philip Lee has assumed the role of GeneFab’s CEO. (bioprocessintl)

• Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing, has secured $255 million in Series C funding. The company plans to use the money to launch the world’s first commercial-scale IDMO Smart Factory, which seamlessly integrates advanced robotics, purpose-built technology, and interconnected software. The 118,000-square-foot IDMO Smart Factory, located in Bridgewater, NJ will be capable of producing 40,000 cell therapy batches per year. The funding was Led by new investor Koch Disruptive Technologies and participated by Bristol Myers Squibb DFJ Growth, Willett Advisors, Eclipse, Decheng Capital, and 8VC.

• BlueWhale Bio Founded with $18M Financing led by Danaher Ventures to Accelerate Cell Therapy Manufacturing. BlueWhale Bio Science Team led by world-renowned immunotherapy pioneers Carl June and James Riley of University of Pennsylvania.

• AGC Biologics expanded its cell therapy facilities at its Longmont campus in Colorado. The capacity update includes three new Grade B cell therapy suites, with over 30,000 sf of additional space (RegMedNet)

• CordenPharma has increased commercial peptide production capacity with newly upgraded facilities at their Boulder, CO facility the largest Solid-Phase Peptide Synthesis (SPPS) Manufacturing facility worldwide (PR)

• Renaissance Lakewood, LLC, a pharmaceutical CDMO, expanded its quality control spray/particulate laboratory and both analytical and formulation R&D laboratories in Ocean County, NJ (contractpharma)

• NexPoint Announces Co-investment in NexPoint Life Sciences II DST, Continuing Commitment to Life Sciences with a Focus on CDMOs and cGMP Facilities. The DST acquired the two properties earlier this year. The properties, located in Philadelphia, PA, are occupied by a subsidiary of Adare Pharmaceuticals, Inc., a CDMO focused on oral dosage forms for the pharmaceutical industry (PR)

• PackGene Biotech and Kudo Bio have partnered to provide high-quality, customized mRNA manufacturing services for drug and vaccine development. The global collaboration provides end-to-end coverage of mRNA development, from gene to mRNA, lipid nanoparticle (LNP) formulation development and encapsulation, through to fill-finished drug product, under GMP guidelines (PR)

Europe CDMO Updates:

• MaaT Pharma and CDMO Skyepharma unveil bespoke, and potentially largest, microbiome facility in Europe, . Completed in 12 months, the 17,200 sf facility in France was designed from scratch to specifically house the manufacturing of MaaT’s microbiome cancer therapies (endpts)

• Almac Group Opens Custom Built GMP Warehouse. The new custom-built facility will consolidate the existing warehouses to support all manufacturing and laboratory activities (contractpharma)

• FUJIFILM Diosynth Biotechnologies Announces New Darlington, UK Viral Vector Gene Therapy Facility is cGMP Ready for Manufacturing (PR)

• Rentschler Biopharma’s ATMP facility in Stevenage, UK, receives MHRA approval, UK site now set for clinical production of adeno-associated virus (AAV) vectors for gene therapy (PR)

• Recipharm, and Spanish Biotech Ahead Therapeutics Partner on Rare Autoimmune Disease Therapy. Recipharm will provide analytical and process development capabilities to support toxicology studies, as well as GLP manufacturing of lipid nanoparticles (contractpharma)

• Active pharmaceutical ingredients manufacturer EuroAPI has agreed to acquire BianoGMP, a contract development and manufacturing organization (CDMO) specializing in oligonucleotides. Biano is to become a EuroAPI company but retain its corporate brand (chemmanager)

• Charles River Laboratories International, have announced a High Quality (HQ) plasmid manufacturing collaboration with Fondazione Telethon. The rare disease organisation will leverage Charles River’s market leading cell and gene CDMO expertise in High Quality plasmid DNA production, and Good Manufacturing Practice- (GMP) compliant plasmid DNA batches to manufacture HQ plasmid DNA for Fondazione Telethon’s lentivirus production that will be used in ex vivo cell and gene therapy (pharmaceuticalmanufacturer)

• Rentschler Biopharma agreed to collaborate with Cell and Gene Therapy Catapult and Refeyn to develop and apply novel process analytical technologies (PAT) to improve the process and efficiency of AAV manufacture (genengnews)

APAC CDMO Updates:

• Australia's AcuraBio winds up CDMO business a year after PE takeover. In September 2022, private equity firm Ampersand Capital Partners acquired LuinaBio. A year on, the renamed CDMO AcuraBio has folded (BPI)

• Samsung Biologics adds to BMS manufacturing partnership with new $242M antibody agreement (fiercepharma)

• Porton Advanced announced a strategic partnership with BRL Medicine. Collaboration will enhance the cell and gene therapy pipelines from BRL Medicine from clinical trials to further expedite the commercialization of innovative therapies (PR)

• Samsung Biologics invests and signs collaborations with Korean biotech AimedBio. The ADC company is multi-omics and AI-driven big data analysis of patient samples, AimedBio specializes in the discovery and development of medicines for severe neurological diseases, such as brain cancer, Alzheimer’s disease, and Parkinson’s disease (contractpharma)

• Mabwell and WuXi XDC Sign Long-Term ADC Strategic Collaboration to Accelerate Global Layout of Innovative Biologics (PR)

• Biocon arm Syngene to invest Rs 800 crore in mega expansion of Hyderabad research & innovation campus (timeofindia)

• Eminence Opens GMP Cell Culture Media Manufacturing Facility in Suzhou Industrial Park. Aims to address the rapidly growing demand for high-quality media in the fields of vaccines, gene, cell therapies, antibodies, and recombinant proteins (contractpharma)

• ST Pharm breaks ground on 2nd oligonucleotide manufacturing plant in South Korea (koreabiomed)

• Sanner, a German contract manufacturing and development organization (CDMO), is expanding its production capacity in the Asia-Pacific region with the opening of a second manufacturing facility in Kunshan, China (chemanager)

• Large Molecule CDMO Canton Biologics Completes Over 300 Million Yuan Series C Financing, Led by SDIC Venture Capital (biospace)

• HK inno.N said it has signed a contract manufacturing agreement (CMO) with Brexogen, a company specializing in exosome therapeutics, to produce cell lines for exosome therapeutics derived from stem cells (KBM)