Thursday, October 27, 2022 Daily Archives

Andelyn opens CGT manufacturing plant in Ohio

CDMO Andelyn Biosciences has opened a clinical and commercial manufacturing facility in Columbus, Ohio to support cell and gene therapy (CGT) development. Contract development manufacturing organization (CDMO) Andelyn has opened a manufacturing facility in Ohio, which it has named the Andelyn Corporate Center (ACC). The firm says that the 200,000 square-foot gene therapy production plant has the capability to support any scale of gene therapy viral vector manufacturing. “We built the ACC in response to increasing customer demand for regulatory-compliant, high…

Another FDA inspection ends in 483 for Catalent in Belgium

A US FDA inspection of a fill/finish facility in Brussels has landed Catalent with another Form 483, this time with nine observations. The Form 483 followed the inspection of the drug product, run by contract development and manufacturing organization (CDMO) Catalent, in August and September this year. Deficient air supply in aseptic areas, unexplained batch discrepancies, unestablished control procedures, and inappropriately designed equipment make up the first four observations cited by the US Food and Drug Administration (FDA). “Control over…

Fujifilm Diosynth breaks ground on $300m single-use plant

Fujifilm has begun construction on a facility in Texas described as the largest single-use CDMO production campus in North America. Fujifilm Diosynth Biotechnologies announced the expansion of its College Station, Texas facility December 2021, but work finally began yesterday with the contract development manufacturing organization (CDMO) holding a groundbreaking ceremony. Once operational – by 2024, according to the firm – the $300 million expansion will add 138,000 square feet to the existing 300,000 square feet campus, providing space for multiple…

VectorBuilder raises $57m in China for gene therapy delivery

Chicago-based VectorBuilder, a gene therapy delivery CDMO, raised $57 million in a Series C round from China investors. VectorBuilder develops and optimizes gene delivery products for research institutions and pharma companies. Earlier this year, the contract development and manufacturing organization (CDMO) announced plans to build a $500 million gene delivery manufacturing and research campus in Guangzhou, China. The C round was co-led by Legend Capital, Suikai Investment (55% owned by state-owned firm Guangzhou Development District Investment Group) and Yuexiu Industrial…