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Pfizer mulls facility sale; GSK penalized in South Korea for administrative breach

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Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more.

Pfizer is considering selling a facility it bought from Abzena in North Carolina in 2023 after its gene therapy candidate for Duchenne muscular dystrophy failed to clear a Phase 3 trial in June. The building had already started initial operations and was scheduled to open by year’s end, according to an emailed statement to Endpoints News. No buyer has been identified yet.

GSK received two penalties from South Korea’s Ministry of Food and Drug Safety for failing to report a change in the main ingredient in an asthma product, and for confusing the drug’s manufacturing number and expiration date, according to a report in Korea Biomedical Review. The UK drugmaker said in an emailed statement to Endpoints that it notified authorities as soon as it was aware of the issue and accepts the Korean regulator’s decision.

EuroAPI reported its half-year results on Wednesday, stating that it had a 9.6% decline in net sales to €448.7 million ($484.6 million). The drop was driven by a “strong decrease” in volumes from Sanofi and a pause in work at EuroAPI’s site in Brindisi, Italy. That facility’s GMP license has now been reactivated and it should gradually start production this quarter.

Cytovance Biologics and Celltheon are joining forces to create a “US-based platform solution” for monoclonal antibodies and other proteins that are difficult to express. The service will combine Celltheon’s CHO-K1-based cell line development platform with Cytovance’s CDMO services. The financial terms of the partnership deal were not disclosed.

Repligen’s second-quarter revenues were down 3% from the same period last year to $154 million, but orders were up by more than 20% both sequentially and year-over-year, the company said on an earnings call Tuesday.

Piramal Pharma Solutions’ revenue from innovation programs surpassed revenue from its generics arm for the first time in the company’s history, according to a Tuesday press release.

Charles River Laboratories is working with FOXG1 Research Foundation to help the patient advocacy group advance treatments for rare diseases. Charles River will provide the group access to its cell and gene therapy expertise and help generate materials for clinical trials.

Fourteen staffers were injured when a fire broke out due to an explosion on Monday at the BASF chemical plant in Germany, according to a report by Reuters. The fire was extinguished the same day.

Porton Advanced and Geneseed Biotech have inked a collaboration focused on providing drug development services for circRNA therapies. The financial terms of the deal were not disclosed.

VGXI has been selected as a member of the US government’s Rapid Response Partnership Vehicle, which is working to support BARDA to address “biological threats” such as pandemic influenza and emerging infectious diseases.


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