Tuesday, April 13, 2021 Daily Archives

Manufacturing a Recombinant Retrovirus: Downstream Purification Process Development through GMP Implementation

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This webcast features: Mark Fitchmun, President and CEO, Somatek, Inc. Purification of enveloped viruses and virus-like particles presents several challenges due to their large size and complexity. In this webinar, a case study will be presented and will detail the importance of resin screening, endonuclease treatment, process development, and the scale-up purification of a retrovirus-like particle intended for use in human subjects. The resulting current good manufacturing practice (CGMP) compatible process required approximately four hours to purify 240 L of…

Crude Sample Analysis in Process Development: Time and Cost Savings

This overview highlights a few examples from drug discovery and process development where the Octet® system demonstrated a significant reduction in the analysis time over ELISA and HPLC by eliminating the need for purification, while still achieving high accuracy and precision. The total assay times were dramatically reduced with fewer assay steps and less labor time involved. The easy and versatile, fully integrated Octet® assay has additional advantages over other label-free technologies like SPR, where sample washing steps are required.…

Resilience adds CDMO Ology to growing manufacturing footprint

Five months after launching, Resilience has acquired Ology Bioservices bagging a facility in Florida. The 200,000 square feet of biomanufacturing space joins a growing footprint, which includes a plant in Fremont, California subleased from Orchard Therapeutics. Financial details regarding the acquisition have not been disclosed, but Ryan Flinn, a spokesman from Resilience told us the addition of contract development and manufacturing organization (CDMO) Ology brings more than 200,000 square feet of mostly biologic drug substance manufacturing space, along with 300…