Tuesday, April 26, 2022 Daily Archives

Host cell protein impurities in viral vector manufacturing: a critical quality attribute for product efficacy and safety

Viral vector manufacturing processes require rigorous analytics, including testing for process-related impurities such as host cell proteins (HCP), host cell DNA, growth media additives and enzymes used in viral vector purification processes [Cellular and Gene Therapy Guidances]. Even after multiple purification steps, significant levels of HCP impurities can be present. While low levels of most impurities can be inconsequential, patient safety demands that HCPs be eliminated or reduced to the lowest levels practical to prevent problems such as adverse immune…

China’s I-Mab allegedly seeking asset or company sale

Shanghai-based I-Mab is in talks with global drugmakers about a potential sale of the whole company or its oncological assets, according to a Bloomberg article. The Bloomberg article claims US and EU pharmas were interested in I-Mab, given its portfolio of 10 clinical stage oncology antibodies plus access to the world’s second largest pharmaceutical market. Bloomberg noted that I-Mab has lost three-fourths of its market value since the prices for pharmaceutical companies peaked in June 2021. When it announced its…

Catalent pays Erytech $44.5m for NJ cell therapy plant

Catalent has paid Erytech $44.5 million for its 30,900 square-foot facility in New Jersey and will continue to support its lead candidate. Less than a week after the contract development manufacturing organization (CDMO) confirmed a $350 million expansion at its Bloomington, Indiana site, Catalent has acquired a commercial-scale cell therapy manufacturing facility in Princeton, New Jersey from Erytech Pharma for $44.5 million. The facility is located within the University Square Campus Park and has 16 suites that can be used…