Biocon has received two US FDA 483s with two and six observations at a drug product plant and an insulin API plant, respectively. The first 483 came following a pre-approval inspection of a new injectable manufacturing line for a biologic drug product at the firm’s site in Bangalore, India conducted between February 7 and 15. The Form has since been published by the US Food and Drug Administration (FDA) and the two observations relate to issues with microbial prevention procedures…
A data transfer connection between GE Healthcare’s raw material manufacturing sites and Amgen’s process development center in Massachusetts will be installed to help improve product efficiencies, performance, and quality. He said GE Healthcare and Amgen mutually decided to come together to form this collaboration, – financials of which have not been divulged. According to Olivier Loeillot, general manager for Bioprocess at GE Healthcare Life Sciences, it will allow GE Healthcare to “digitally track and monitor raw materials in real-time on…
Moderna has successfully transferred personalized cancer vaccine capabilities to its recently opened production facility in Norwood, Massachusetts. In July 2018, Moderna Therapeutics opened a 200,000 square foot clinical development manufacturing plant in Norwood, Massachusetts to support its pipeline of messenger RNA (mRNA) therapies. “Since the site opening, we have successfully manufactured clinical grade mRNA and then moved to formulation and went to filling and finally labeling of our vials,†Stéphane Bancel, Moderna’s CEO told stakeholders during his firm’ recent Q4…
With over 75% of new molecules coming from small and emerging biotech, opportunities for third-party manufacturers have never been so large says Thermo Fisher CEO Marc Casper. Thermo Fisher jumped into the third-party biomanufacturing space in August 2017 through its acquisition of contract development and manufacturing organization (CDMO) Patheon for around $7.2 billion (€6.4 billion). The firm has also had capabilities in the CDMO since the early 2000s through its clinical trials’ service offerings. Speaking at the 2019 Barclays Global Healthcare Conference,…