As viruses can arise during the manufacture of biopharmaceuticals, regulatory agencies require viral clearance validation studies for each biopharmaceutical prior to approval. These studies are typically conducted in biosafety level (BSL)-2 facilities and require large capital and human resources. The use of an accurate, economical, and quantifiable noninfectious viral surrogate would enable downstream purification scientists to study viral clearance throughout process development. This report explores the use of a BSL-1 compatible, noninfectious MVM particles to predict viral clearance results over…
Thursday, May 27, 2021 Daily Archives
Robotic CAR? Cytiva and Multiply team on cell therapy automation
Cytiva has partnered with Multiply Labs to create a fully automated robotic system intended to support commercial-scale cell therapy manufacturing. “Cytiva and Multiply Labs want to develop a robotic system that will automate the manufacturing processes for cell therapies and drastically bring down the cost to do so,†Parker Donner, head of Business Development, Cell and Gene Therapy at Cytiva told BioProcess Insider. “While these therapies have proven to be very effective, the manufacturing workflow is overly reliant on manual…
UPenn gene therapy researchers lease space at Discovery Labs
University of Pennsylvania gene therapy researchers have leased space at Discovery Labs’ facility in King of Prussia in a deal designed to expand vector production capacity. The agreement – financial terms of which have not been disclosed – includes two dedicated floors at Discovery Labs’ campus on Swedeland Road. The leased space will house the Penn Vector Core, which is a full-service viral vector manufacturing operation. At present Penn produces viral vectors for use in gene transfer. It supplies vectors…