Industry News

The UK’s Medicines and Healthcare products Regulatory Agency clears two sites in Wuxi, China, for commercial ophthalmic biologic manufacturing and packaging.

The agreement adds a single-plasmid lentiviral vector manufacturing option at AGC’s Milan cell and gene therapy site.

The acquisition of the Tempe, Arizona facility will expand U.S.-based drug delivery device capacity and support the company’s $10 billion manufacturing investment.

The new Leiden-based facility will serve as European headquarters and support regional cell therapy manufacturing as programs move toward commercial supply.

The new facility in Winter Park, Florida aims to optimize delivery of cancer treatments across the southeastern United States.

The integrated platform combines cell line development, process development, and GMP support for early clinical programs.

The agreement gives Sidewinder access to a site-specific ADC platform to support development of next-generation bispecific antibody-drug conjugates.

The effort will evaluate automated manufacturing to advance an investigational CAR-T program targeting glioblastoma toward clinical trials.

Manufacturing for coagulation therapy will shift to the CDMO’s U.S. site in Milford, Massachusetts as the program advances toward Phase III and commercialization.

The expansion, part of a $100 million investment in its global network, will more than double aseptic fill-finish capacity with a new automated isolated filling line.

The agreement supports GMP manufacturing of Nouveau’s lead oncology candidate as it advances toward clinical development.

The assessment could support future capacity expansion as demand grows for Autolus’ approved CD19 CAR-T therapy.

The agreement covers cell line development, process development, and GMP manufacturing for a lead Fc-fusion candidate targeting Type 1 diabetes.

The acquisition adds to Title21’s digital capabilities for healthcare and life sciences organizations across the cell and gene therapy ecosystem.

Skye has licensed Halozyme’s drug delivery technology to enable evaluation of higher-dose subcutaneous administration of an investigational antibody.

The certification reflects the company-wide integration of sustainability into supplier management and follows the CRDMO’s continued expansion of its manufacturing network.

The new Toyama plant adds single-use bioreactor capacity and anchors Fujifilm’s Asia biomanufacturing strategy.

The expanded collaboration supports GMP manufacturing and process development for a stem cell–derived, cell-free therapy entering Phase Ib trials.

The acquisition gives the South Korean CDMO its first U.S.-based manufacturing facility and expands domestic biologics capacity to meet rising demand.

The milestone supports a Phase III cancer immunotherapy program and marks a capacity expansion aimed at late-stage and commercial supply at its Stirling, Scotland site.

The collaboration combines Chinese hamster ovary cell line development with GMP media manufacturing to improve productivity and scalability in biologics production.

The teaming focuses on improving lentiviral and AAV delivery technologies to support more scalable and cost-effective cell and gene therapy manufacturing.

The new automated isolator line expands vial and lyophilization capacity at the CDMO’s Research Triangle Park campus.

The new equipment is expected to support smoother scale-up from development to commercial solid-dose manufacturing.

The investment is expected to expand siRNA capacity, reduce production costs, and support future RNAi product launches.

The Fishers campus expansion is expected to significantly increase sterile fill-finish output and support nearly 1,000 employees by the end of the decade.

The new media are designed to improve plasmid DNA and recombinant protein production while simplifying microbial bioprocessing workflows.

The new financing supports the development of artificial intelligence models meant to enhance molecule design and expedite pathways to first-in-human studies.

The 700,000-square-foot, multi-site project is part of the company’s broader effort to expand domestic production capacity and strengthen U.S. pharmaceutical supply chains.

The agreement focuses on integrating ambient temperature biosample preservation with advanced 3D organoid models to support preclinical research and biotech developers.