The connected manufacturing environment is meant to enable manufacturers to scale production to commercially viable levels without replacing existing processes.
The expanded collaboration adds commercial-compliant packaging and distribution for MCO-010, an optogenetic gene therapy targeting retinal degenerative diseases.
The collaboration with the CDMO covers Phase 3 clinical supply and commercial manufacturing for Arcturus Therapeutics’ investigational cystic fibrosis therapy.
Three facilities passed a five-day inspection with zero findings, enabling end-to-end commercial manufacturing of anti-PD-L1 monoclonal antibody for Brazilian market.
The CDMO said the expanded services are intended to reduce supply chain complexity by minimizing manufacturing handoffs and providing integrated project management.
The deal installs solvent-free amorphous solid dispersion technology at facilities in Bend, Oregon and Cincinnati, Ohio to support late-phase and commercial manufacturing.
The CRDMO’s facility passed an on-site regulatory inspection under stricter contract manufacturing requirements introduced by Chinese drug regulators in 2025.
The collaboration combines gene delivery and cell engineering capabilities to support scalable manufacturing of cell therapies, including CAR-T, CAR-NK, and iPSC.
The agreement will establish GMP lipid nanoparticle production in Abu Dhabi as an initial step toward fully integrated gene-editing therapy manufacturing.
The MFG17 facility at the company’s Shanghai Fengxian site in China adds 9,000 liters of single-use bioreactor capacity supporting 80 to 100 batches annually.
The 128,000-square-foot Andover, Massachusetts facility will serve as the company’s U.S. manufacturing site, supporting development of its targeted alpha therapy pipeline.
The collaboration will combine CDMO capabilities with consulting and supply chain expertise to support complex therapy development and commercialization.
The acquisition of the Hanau production site for pharmaceutical ingredients is meant to complement ProChem’s capabilities in chemical production and analytics.
The CDMO is moving its corporate headquarters from San Diego to Blue Ash, Ohio, and adding a multi-purpose injectable fill-finish line at its West Chester facility.
The Bohumil site will initially produce supportive proteins for next-generation diabetes and obesity medicines as part of Novo Nordisk’s global manufacturing network.
The inspection supported EU marketing authorization applications for 19 biologics spanning antibodies, enzymes and fusion proteins from 13 clients, according to company.
The tool is designed to analyze the CDMO’s data to accelerate root cause analysis and corrective action development for deviations and complaints across its network.