Three biomanufacturers are joining forces to spotlight how starting material quality drives scalability and consistency in cell and gene therapy production.
S-RACMO, a subsidiary of Tokyo-based Sumitomo Chemical, has completed its third facility and has plans for a fourth as demand for cell therapy CDMO services grows.
The 200,000-square-foot facility in New Windsor, Orange County will be the world’s largest producer of chlorhexidine, a disinfectant and antiseptic used in hospitals.
Becton, Dickinson and Company said the expansion at the Columbus site will allow it to produce hundreds of millions of additional units annually to meet growing demand.
The agency’s new two-phase regulatory framework seeks to strengthen domestic supply chain and reduce foreign dependence on active pharmaceutical ingredients.
The Chinese CRDMO’s newest GMP-compliant facility in Wuxi adds seven million vials of annual capacity, expanding its bioconjugate drug product network.
The collaboration will embed AI-driven modeling into Repligen’s tangential flow filtration systems to speed process development, according to the companies.
The expansion will make the Aachen, Germany-based biotech the largest producer of Human Platelet Lysate and create new skilled jobs in the region, according to the company.
The CDMO’s retroviral vector will be used to manufacture AvenCell’s investigational dual-targeted therapy for B cell malignancies and autoimmune diseases.
The 200,000-square-foot facility will serve as a regional hub, offering increased production capacity and local support for pharmaceutical customers in Asia.
The company said it is expanding its cGMP manufacturing footprint and AI-powered development systems to strengthen domestic production of essential medicines.
The new platform will support formulation development for poorly soluble drug candidates and create research and development jobs in Killorglin, said the company.
