Monday, June 28, 2021 Daily Archives

Horizon acquires Irish facility for $65m

by

Horizon says it is the right time to add inhouse manufacturing capabilities as it acquires a facility from EirGen Pharma. Horizon Therapeutics will pay OPKO health’s EirGen Pharma $65 million for the 44,000 square-foot drug product manufacturing facility located in Waterford, Ireland. The facility includes a filling line, lyophiliser or freeze dryer, which can be used for the firm’s commercial medicines such as Tepezza (teprotumumab-trbw), Krystexxa and Uplizna (inebilizumab-cdon) plus other drugs in its pipeline. The successful launch of Tepezza,…

June 28, 2021

Genezen breaks ground on lentiviral vector facility

by

CDMO Genezen will build a lentiviral vector manufacturing facility to support clients and early-stage clinical trials. Gene therapy contract development manufacturing organization (CDMO) Genezen Laboratories will construct a 75,000+ square-foot lentiviral vector production facility in Indianapolis, US. The investment contributes to Genezen’s lentiviral and retroviral vector production, which enables the CDMO to support current and future clients to supply early phase clinical trials. “Lentiviral vectors are the leading platform for in-vitro gene therapy, representing over 35% of the clinical trial market and it…

June 28, 2021

US FDA aims to clarify reporting rules for biologics CMC changes

by

Biologic drug makers that tweak manufacturing processes after approval have a better idea of when and how to inform the US FDA of the changes thanks to new agency guidelines. The US regulator issued the final guidance document last week, explaining the aim is to help biologics makers determine which reporting category is appropriate for a chemistry, manufacturing, and controls (CMC) change. The guidance – which applies to biologics, vaccines, cell and gene therapies, plasma-derived medicines but not whole blood…

June 28, 2021