AGC Biologics has named Tadashi Murano, president of its AGC Life Science Company, as interim CEO while the company searches for a permanent CEO. Murano succeeded Patricio Massera, who stepped down June 30. Also in June, AGC completed an approximately $200 million, 19,000 square-meter (204,514 square-foot) manufacturing building at its Copenhagen campus, doubling the site’s single-use bioreactor capacity for mammalian services and allowing it to produce 150 more batches of drug product each year.
And Essential Pharma’s rare disease business signed a strategic agreement with AGC Biologics to produce Hu1418K322A (Hu14.18), a humanised monoclonal antibody for the treatment of high-risk neuroblastoma. The Danaher-owned provider of custom development and manufacturing services agreed in May to partner with Acuitas Therapeutics, which develops delivery systems for nucleic acid therapeutics based on lipid nanoparticles (LNPs).
The partnership is designed to help Aldevron expand its capabilities in messenger RNA (mRNA) LNP encapsulation by incorporating Acuitas’ proprietary LNP encapsulation platform, increasing Aldevron’s services and capabilities as an mRNA sequence-to-vial custom manufacturer. Aldevron is planning a $200 million-plus expansion of its building in Eden Prairie, MN, that would add 96,244 square feet to its existing 350,000-square-foot facility. The project, set for completion in 2026, would add to the company’s manufacturing, warehouse, and office space.
Avid Bioservces finished the fiscal year ending April 30 with record-high fourth quarter revenues of $139.911 million, which while down 6% from $149.266 million in FY 2023, included a record-high fiscal fourth quarter with revenues of $42.
975 million, up 8% year-over-year. The company credited the revenue jump primarily to a greater mix and scale of manufacturing runs and process development services, mainly due to new programs. Avid has offered investors optimistic FY 2025 revenue guidance of $160 million-$168 million, representing 17% growth year-over-year at the midpoint.
During FY 2024, Avid completed and launched a new cell and gene therapy manufacturing facility in Costa Mesa, CA. Taipei-based Bora Pharmaceuticals expanded into the U.S.
in January by acquiring generic drug manufacturer Upsher-Smith Laboratories for $210 million from its Japanese owners, key shareholders Sawai Group Holdings and Sumitomo Corporation of Americas. In June, Bora agreed to acquire the 87,000-square-foot Camden fill-finish drug product facility in Baltimore from Emergent BioSolutions for approximately $30 million. has clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.
The Camden facility’s approximately 350 Emergent employees are expected to join Bora upon completion of the transaction, which is expected in the third quarter. Charles River includes revenues from CDMO activity within its Manufacturing Solutions segment, which also includes revenue from Microbial Solutions and Biologics Testing businesses. The company does not break down the segment to furnish a CDMO revenue figure—but has announced several CDMO-related efforts in recent weeks.
Charles River launched a CDMO agreement with the FOXG1 Research Foundation (FRF) designed to advance development of gene therapies for rare diseases. Also in July, Charles River agreed to develop plasmid DNA for the Stargardt’s disease program (AAVB-039) of AAVantgarde, which developed the treatment through its AAV-intein platform, one of the company’s two AAV-based large gene delivery platforms. Charleroi, Belgium-based Exothera, a Univercells company, in March expanded into North America its nucleic acids service offering based on its NtensifyTM manufacturing platform, which according to the company is the world’s first continuous-batch RNA production platform.
Developed by Exothera’s sister company Quantoom Biosciences, Ntensify is designed to accelerate the production of RNA therapeutics by transitioning seamlessly from clinical to commercial-scale manufacturing, without process development or scale-up. Exothera has also launched an expedited research use only (RUO) mRNA synthesis service with a four-week turnaround time from order placement to delivery. In June, Lund, Sweden-based Asgard Therapeutics selected Exothera for process development up to clinical Phases I/II manufacturing of its off-the-shelf gene therapy candidate AT-108.
The biologics CDMO subsidiary of Nanjing, China-based GenScript in June opened a new 128,000-square-foot facility in Hopewell, NJ, that is the hub for the company’s North American operations and has, according to the company, significantly enhanced its capability to support the manufacturing of cell and gene therapies in North America. The facility’s office, laboratory, and manufacturing spaces have been outfitted with technology for process development and cGMP production of plasmid DNA and viral vectors, including AAV, lentivirus, and retrovirus. In February, GenScript ProBio signed a collaboration agreement with Cell Resources Corporation, a subsidiary of Alfresa Holdings, offering comprehensive CDMO services for preclinical development and GMP manufacturing of various cell therapies in Japan.
Viralgen inaugurated its new MSAT (Manufacturing, Science and Technology) laboratory in May at the Science and Technology Park of the Basque Country in Donostia, Spain. The €10 million (about $11 million) facility is designed to accelerate the development and delivery of treatments for rare genetic diseases by combining initial clinical activities with the production of AAVs. In February, Viralgen Vector Core, Viralgen Commercial Therapeutic Vector Core, TAAV Biomanufacturing Solutions, and Quality Advanced Therapies Research partnered to form the MAPAAV project, aimed at the development of a high-performance analytical platform to ensure the safety, purity, and efficacy of AAVs for gene therapy.
Viralgen was founded in 2017 by U.S. gene therapy developer Asklepios BioPharmaceutical (AskBio) and Columbus Venture Partners, a Spanish venture capital firm focused on biotech investment.
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