Just before the start of the new year, Novo Nordisk revealed its supply of obesity med Wegovy was low and that it would not be able to meet demand in the US until the second half of 2022.

Thanks to a Form 483 from the FDA, we now know that issues at Catalent’s flagship syringe filling site in Brussels, Belgium, was the reason for the delay, BioProcess International reported.

The site is 265,000 square feet and has been handed 12 483s in nine FDA visits, a source told BioProcess, though it is believed that this is the first that has halted production.

A Philadelphia Catalent site will get an increase in cold-chain packaging capabilities to gear up for any future increases in gene and cell therapies.

The site will be expanded by 20,000 square feet and add an additional seven temperature-controlled processing suites. Those suites can either be in refrigerated or frozen conditions to match the needs of the drugs handled. There will also be more storage space, and the suites are designed for small-scale batches of commercial products.

The manufacturing process to make biosynthetic heparin, a drug used for preventing blood clots, is not a particularly clean one.

In a slaughterhouse, someone must remove the intestine casings from a pig. The mucosal linings are then scraped. The steps to get heparin are enormous, and the process is complicated.

“It’s not like you kill a pig and you have heparin,” Ohio-based Optimvia CEO Keith Kleeman told Endpoints News in an interview. “It’s a filthy, disgusting place for a medication to start. I can’t think of a more disgusting place for an important medicine to start.”

A Pennsylvania CDMO specializing in cell and gene therapy manufacturing is receiving a big influx of cash from a South Korean drugmaker — and it has plans for a major hiring spree.

SK, the holding company of SK bioscience, will invest $350 million of equity financing into the Center for Breakthrough Medicines, with plans to add an additional 2,000 employees as part of a redux at the CDMO’s King of Prussia, PA facility.

In a bid to expand R&D and manufacturing capabilities, Shanghai-based ZhenGe Biotech netted a $100 million Series C Tuesday.

With offices in Shanghai and the US, the transpacific CDMO garnered the support of Goldman Sachs Asset Management, who co-led the financing round with Sofina. Other investors joined in the round, including Novo Holdings, Qiming Venture Capital, and several other firms.

The series brings the company up to $225 million raised since it was founded in 2017. As part of the raise, ZhenGe named Kevin Xu, a managing director at Goldman Sachs Asset Management, to its board.

It’s been six months since the last incident, but 2021 ended with the tally resetting back to “zero days.”

Viona Pharmaceuticals is recalling 33 lots of metformin hydrochloride after finding traces of NDMA, a known probable human carcinogen with cancer-causing potential. It’s a much larger recall than the two lots of 750 mg extended-release tablets it recalled in June.

Metformin is used to help improve glucose control in adults with type 2 diabetes, and is packaged in bottles of 100 tablets. The drug can be identified by its capsule-shaped, uncoated off-white color tablets that feature a “Z” and a “C” on one side and “20” on the other.