Wednesday, May 31, 2023 Daily Archives

eXmoor to become CGT CDMO with $35m funding

The funding will support the launch of a CGT facility in Bristol, UK and cement the firm’s CDMO status, says eXmoor pharma. Cell and gene therapy (CGT) firm eXmoor said the expansion, funded by a $35 million Series A financing round, will complete its movement into a full-service CGT contract development and manufacturing organization (CDMO). “eXmoor has been supporting the CGT industry for the last 15 years developing right first time CMC strategies and manufacturing facilities (via our translation and…

UCB hit with Form 483 at Belgium drug product facility

Quality control issues have landed UCB Pharma a Form 483 following an inspection of its facilities in Braine-l’Alleud, Belgium. UCB Pharma underwent an inspection of its manufacturing facilities in April, resulting in the issuance of a Form 483 by the regulatory authority. A Form 483 is a document used by the US Food and Drug Administration (FDA) to notify a company of observed deviations from Good Manufacturing Practices (GMP) during an inspection. During the inspection, the FDA identified certain deviations…