Monday, July 3, 2023 Daily Archives

Merck KGaA forks out $76m to expand reagent production in China

Germany’s Merck said the investment in Nantong, China will add manufacturing capacity to provide customers with reagents for quality control and testing. MilliporeSigma, the life sciences division of Merck KGaA, and the Nantong Economic and Technological Development Area (NETDA) signed the agreement for the expansion last week. The €70 million ($76 million) investment will enable large-scale manufacturing of high-purity reagents for quality control and testing for biopharma clients and will increase annual output by several thousand tons. The firm will…

BioMarin gets FDA greenlight for Roctavian

The US Food and Drug Administration (FDA) has approved BioMarin’s single-dose hemophilia A gene therapy, Roctavian (valoctocogene roxaparvovec). Roctavian has been designed to replace the function of the mutated gene, which enables the individual to produce their own FVII protein and thus decrease bleeding episodes. In Europe, Roctavian received approval in June 2022. “Today’s approval of Roctavian builds on BioMarin’s proven track record of advancing treatments that target the underlying cause of life-threatening genetic conditions, which has produced eight best or…

Opening of California facility helps us become a clinical stage company, says Senti

Senti Bio has opened its facility in Alameda, California where Phase I clinical materials for its lead investigational therapy will be produced.   Senti Biosciences, a cell and gene therapy (CGT) firm, leased the 90,000 square-foot manufacturing facility in Alameda in June 2021. Now, the company has opened the facility and said it is the latest step it has taken to become a clinical stage company. “The opening of this new space is the latest step for Senti on its…

Lack of CDMOs a challenge for patch-based vax delivery, says Vaxess

Vaxess says one of its biggest challenges in delivering a patch-based vaccine is there is not a contract manufacturer with the expertise to produce the product. Vaxess, a company that aims to engineer more effective and accessible vaccines and therapeutics by focusing on the skin as an active immune organ, is developing a patch-based delivery system. Its lead program MIMIX-Flu is a seasonal influenza vaccine that is mailed directly to patients’ homes for self-administration. The patch works by applying it…