Oncolytic viruses (OVs) have the potential to become a very important pillar in the treatment of cancer because of their dual mechanism killing infected cancer cells and triggering anticancer immune response to also destroy uninfected cancer cells. This motivates researchers continually optimize oncolytic viral vectors to further improve their safety, efficacy as well as manufacturability for a commercial scale-up. As biopharmaceutical manufactures just begin to explore the prospect of OVs based therapies, the need for contract development and manufacturing organizations…
Wednesday, October 12, 2022 Daily Archives
NJ plant woes continue for Lilly with reports of FDA 483
Eli Lilly has received an FDA Form 483 citing further manufacturing issues at its Branchburg, New Jersey facility, Reuters reports. The Reuters’ exclusive was based on a redacted copy of the Form 483 – obtained under a Freedom of Information Act request – which followed an inspection at the Branchburg facility by the US Food and Drug Administration (FDA) in July. Among the issues highlighted, Reuters said: “Lilly personnel found ‘unknown debris’ in a production area and that raw drug…