The new 375,000-square-foot Mebane facility, which is a carbon neutral site, will produce up to 40 million pipette tips per week, according to the company.
The review extension follows FDA observations at a former Catalent facility now owned by Novo Nordisk, which handles final preparation and packaging of Eylea HD.
The Chinese CRDMO attributed the results in the first half of 2025 to operational efficiency gains, technology platform expansion, and facility ramp-ups in Europe.
The expansion adds aseptic lines for syringes and vials, formulation and R&D capacity, and commercial-scale packaging capabilities at its Brooksville, Florida site.
The Dundalk facility includes 6,000 liters of perfusion capacity and 48,000 liters of fed-batch capacity, making it a key hub in the Chinese CRDMO’s global network.
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.
