The deal, worth $700,000 plus a royalty stream of 12.5%, covers Australia and New Zealand.
HALIX, a Dutch contract development and manufacturing organization (CDMO) focused on clinical and commercial proteins and viral products, has marked the interim completion of a new cGMP facility that will specialize in developing and producing biopharmaceutical drug substances.
Firms believe combined expertise will speed development of new APIs.
Agency chides BI for not sufficiently investigating and correcting “significant" API, finished-product violations.
The facility is expected to have the same annual output as a conventional facility but in a single building.
The cellular factories that churn out recombinant proteins may adopt their own version of lean manufacturing: intensify everything that adds value and curtail everything else. To date, yeast and other tiny protein factories have...
Fidaxomicin is part of a new class of antibiotics called macrocycles.
Agreement covers liquid handling platforms, ELISA analyzer, microplate readers, and microplate washers.
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