Bristol Myers reports shortage of chemo drug abraxane; Sartorius more than doubles capacity with Michigan expansion
Manufacturing delays have led to a shortage in abraxane, Bristol Myers Squibb says.
The announcement comes on the heels of the FDA shooting down a petition to stall generic version of the drug. Five years after the petition was filed, the FDA rejected it completely in July. The chemotherapy drug brought in more than $1.2 billion for Bristol Myers in 2020.
The shortage affects 100 mg vials of the intravenous lyophilized powder.
Stephen Liu, a thoracic medical oncologist and associate professor at Georgetown University, tweeted the announcement last week, wondering aloud if drug shortages are impending after supply chain issues.
Just learned that abraxane is on manufacturer backorder with no release date. Wondering if drug shortages are the downstream effect of supply chain issues and is this the start of something bigger. Hopefully it's just an isolated thing… pic.twitter.com/YjrOZYpYB0
— Stephen V Liu (@StephenVLiu) September 24, 2021
Sartorius blows out expansion plans in Michigan
German manufacturer Sartorius has announced an expansion in Michigan with the addition of a 130,000-square-foot plant in the Ann Arbor Research Park.
The project is set to go online by 2023 and is expected to create 150 jobs over the next three years. Sartorius has 22 sites across the world. The Michigan location will enable the company to scale up, and by 2025 the plan is to more than double its production capacity.
Sartorius Stedim Biotech acquired a majority stake in Germany-based CellGenix GmbH, the companies announced in June.. Sartorius has acquired 51% of the company for $118.3 million and announced the plan to acquire the remaining shares of the company at the beginning of 2023 and 2026. The company will expand the Freiburg site and establish it as a manufacturer of raw materials for cell and gene therapy.
Insulin facility in Malaysia handed Form 483
A Malaysian subsidiary of Biocon has landed in more hot water with the FDA after another Form 483 has flagged six more observations connected to drug substance, drug product and the devices facilities.
The problems stem from a September inspection. The site manufactures insulin aspart injection.
“We are confident of addressing these observations through procedural enhancements and an appropriate Corrective and Preventive Action Plan, which will be submitted to the US FDA in the stipulated time,” Biocon said in a statement. “We do not expect the outcome of this inspection to impact our commercialization plans for insulin Aspart in the US. Biocon Biologics remains committed to global standards of Quality and Compliance.”
Almac expands footprint in Ireland
Northern Ireland is getting a new manufacturing site that will bring another 60 jobs to the region.
Labs, storage spaces, and offices are all a part of the planned expansion, and the plan includes changes to access roads, parking lots and paths. Proposals have been submitted to Armagh City, Banbridge and Craigavon Borough Council for consideration, according to reports from Armagh I.
The new site will add another 42,000 square feet to the company’s footprint.