July 27, 2018
Alexion sells its troubled plant to Rubius; Samsung BioLogics receives its first US license to make a Mab drug product; WuXi Biologics completes a GMP run at its Shanghai facility. Welcome to Insider’s facility round-up.
Earlier this month, BioProcess Insider reported newly public Rubius Therapeutics had pledged to invest US$155 million (€133 million) to purchase, renovate and customize a facility in Smithfield, Rhode Island.
At the time, the firm refused to divulge who they bought the facility from, but in a note filed with the SEC it has revealed the seller is Alexion Pharmaceuticals, to whom Rubius is paying $8 million.
Rare drugmaker Alexion announce it was closing the 135,000 square foot facility in September last year, cutting 250 jobs at the site.
The plant had been used to make the active pharmaceutical ingredient (API) for Alexion’s immunosuppressant Soliris (eculizumab) as well as the finished product, but fell subject to US Food and Drug Administration (FDA) criticism.
The Agency issued Alexion with a warning letter in 2013 after inspectors spotted a number of deviations from current good manufacturing practices (cGMP), including the detection of “residues in already-cleaned equipment.” Two subsequent reinspections of the plant ended with Alexion receiving Form 483s.
Over to South Korea now, and biologics contract development and manufacturing organization (CDMO) has received US FDA approval to make the drug product for an undisclosed monoclonal antibody at its plant number 1.
The facility has European and Japanese approvals to make end-to-end products but this is the first drug product approved for the US market.
The first plant at the Songdo, Incheon site offers 30,000 L of stainless steel biomanufacturing capacity, while a second facility boasts 152,000 L. The first monoclonal antibody drug substance FDA approval at the second plant was received last October.
A third plant with 180,000 L of bioreactor capacity – set to be the largest single plant in the world – was mechanically completed last November, and is expected to be validated by the fourth quarter this year.
Staying in Asia, fellow CDMO WuXi Biologics completed the first GMP run at its manufacturing facility in Shanghai, China.
The facility, known as MFG3, boasts 5,200 L of single-use fed-batch bioreactor capacity, and 1,500 L of perfusion bioreactors, and will be used for clinical manufacturing.
“With this newly added capacity, WuXi Biologics will be able to enable 60 IND projects and 3 BLA projects per year, which showcases our unparalleled capacities,” said CEO Chris Chen.
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