The new site in Hopewell will provide scalable, end-to-end adeno-associated virus production capabilities in a single U.S.-based location, according to the company.
The Waltham, Massachusetts facility met nine system criteria under the Initiative for Certification of Manufacturing Capabilities program, the company said.
The investment is part of the drugmaker’s previously announced plan to invest more than $10 billion in its U.S. manufacturing operations over the next 10 years.
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.
