Monday, March 16, 2020 Daily Archives

Grist for the MIL: CDMO Cognate making cell therapies for WindMIL

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WindMIL Therapeutics has upped a contract with Cognate BioServices to make its marrow-infiltrating lymphocyte (MIL) cell therapies but says it is developing plans to eventually build in-house manufacturing capabilities. WindMIL, a cancer immunotherapy firm developing autologous cell therapies based on its marrow-infiltrating lymphocytes (MILs), initially began working with contract development and manufacturing organization (CDMO) Cognate last year. Now the firm has expanded the contract to add extra clinical manufacturing capacity. “We are securing one additional manufacturing suite at Cognate’s Memphis,…

March 16, 2020

Autolus hires MolMed to add vector flexibility

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Autolus Therapeutics says hiring MolMed as a contractor for its CAR-T programs was about adding flexibility. The biotech announced contracted MolMed to develop and manufacture vectors for its candidate CAR-T cancer therapy programs this week. Under the deal MolMed will make viral vectors to support Autolus’ various clinical trial programs. An Autolus spokeswoman told us “MolMed is a future supplier. “The MolMed relationship is Autolus taking the normal and prudent step to build flexibility and parallel supply for vector.†The…

March 16, 2020

Compounders complain they can’t make these four drugs once they’re deemed biologics

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After 23 March, the US FDA won’t allow any more bulk compounding of four oft-compounded drug substances, disrupting patient care, compounders say. Major disruptions in patient access to compounded versions of four bulk drug substances may result from the US Food and Drug Administration’s (FDA’s) decision, announced 5 March, to regulate them beginning 23 March as biologics licensed under the Public Health Service Act, drug compounding industry groups say. The announcement said outsourcing facilities complained four substances on the FDA’s preliminary list would be…

March 16, 2020