The extension builds upon an existing long-term collaboration for end-to-end ADC manufacturing, including payload, monoclonal antibody (mAb) manufacturing and bioconjugation
The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
The investment will help the company meet soaring demand for user-friendly oral dosage form development and manufacturing
InvaGen has received 5 inspectional observations in Form 483
The inspection was a cGMP Inspection and had ended with NIL observations
The company will develop and produce premixes for human nutrition applications
The facility has a potential for capacity expansion up to 2 billion tablets/capsules per year
Exothera will manufacture Meissa’s MV-012-968 vaccine candidate under CGMP regulations to supply Phase 2 clinical trials
Under the terms of the collaboration, Vertex and Lonza will partner in the process development and scale-up for the manufacturing of the product portfolio and co-invest to build a dedicated new facility in Portsmouth, New Hampshire (US)
Carbogen Amcis Manchester won the industry award in recognition of its efficiency improvement program implemented in response to increased demand for its products
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