Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more.
Vedanta Biosciences will lay off 12 workers from its CMC team, and a “similar number” of staffers in other positions, as the company is “coming off a peak of manufacturing campaigns that supplied several mid and late-stage clinical studies,” CEO Bernat Olle wrote Friday on LinkedIn.
Kincell is acquiring Imugene’s cell therapy manufacturing facility for up to $6 million upfront along with milestone payments. Kincell will continue to make Imugene’s Azer-cel asset as it moves through clinical trials, the companies announced on Tuesday.
Evergreen Theragnostics has raised $26 million to expand its CDMO capabilities and advance its radiopharmaceutical pipeline to clinical trials. The raise was funded by investors Petrichor and LIFTT, as well as existing shareholders, according to a Tuesday release.
Africa’s Centres for Disease Control and Prevention communicated its “disappointment” in Moderna halting its vaccine manufacturing site build in Kenya. “To blame Africa and Africa CDC [for reduced vaccine demand] only serves to perpetuate the inequity that characterized the response to the Covid-19 pandemic,” the agency said in a Monday release.
Sun Pharmaceutical received a Form 483 after an FDA inspection of its site in Dadra, India, in December. The agency made six observations, including failure to investigate batch discrepancies and equipment that was not properly cleaned. The letter was published on the FDA website on Wednesday.
Eugia Steriles was also issued a Form 483 after an inspection at its site Anakapalli, India. The inspection, which took place between March 28 and April 4, found three observations, including computer records not checked for accuracy and workers not following procedures to prevent microbial contamination.
CDMO Curida is speeding up its facility expansion plans through investment from private equity firm Signet Healthcare Partners. Financial details were not disclosed. Curida also said it is appointing Anders Larsson, who previously served as COO, as its new CEO. Larsson will start the new role in May. Larsson’s predecessor, Ole Dahlberg, will move to chairman of the board, according to a Tuesday release.
AGC Biologics is adding two of Cytiva’s manufacturing platforms at a new site in Yokohama, Japan, for clinical and commercial production of mRNA vaccines, drug substances and monoclonal antibodies. Cytiva will also supply additional equipment for cell therapy manufacturing. The Yokohama facility will have cell therapy services online in 2025, and the rest of the site will be operational in 2026, as per a Thursday release.
Ypsomed is partnering with the CDMO ten23 health. Both companies are investing in infrastructure and technology to advance Ypsomed’s patch injector, as announced on Tuesday.
BioHarvest is leasing an 80,000-square foot facility in Yavne, Israel, for $5.5 million and will furnish 12 clean rooms for $3.6 million, the company said on Tuesday.
SK pharmteco and Ferring Pharmaceuticals are partnering to scale up commercial manufacturing capacity for Ferring’s gene therapy Adstiladrin, the companies announced on Thursday.
