Friday, November 12, 2021 Daily Archives

Hot off the Press: Quality by Design for AAV manufacture

by

Chemistry Manufacturing and Controls (CMC) for gene therapies is one of the biggest obstacles when moving towards regulatory approval and presents a significant risk to the success of new gene therapy drug candidates today. A key aspect to the CMC documentation of such complex biological products is the application of the Quality by Design (QbD) principle: A rationale of quality being achieved by process design rather than relying on final quality testing alone. The work presented here provides a framework…

November 12, 2021

Container Closure Integrity: Testing of Bottles Used for Cell Therapy Applications

by

This webcast features: Eric Isberg, Vice President, Life Sciences, Savillex Container integrity is critical when storing and shipping cell therapy products to ensure sterility. The security and durability of the container sealing region(s) should be weighed against usability of the container in clinical settings common to cell therapies. A study was performed to evaluate and quantitatively measure the associated leak rate for the container closure integrity of fluoropolymer bottles per USP <1207> Package Integrity Evaluation – Sterile Products using helium…

November 12, 2021

Pall hiring 300 to staff South Carolina plant

by

Pall will hire 300 people to staff its single-use bioprocessing manufacturing facility in Duncan, South Carolina. Cytiva and Pall announced a $1.5 billion investment in July (in addition to Cytiva’s $500 million growth strategy that was announced in September 2020 and January) to expand manufacturing capacity for life sciences products at thirteen Danaher Corporation sites to meet customer demand. Part of this investment includes the construction of facilities in the US and the UK over the next two years. Now Pall is…

November 12, 2021

UK CAR-T plant could open doors for Autolus to reenter US

by

Having ditched a manufacturing plant in Maryland, Autolus Therapeutics has broken ground on a facility in the UK, which – alongside $250 million in investment from Blackstone – aims to support CAR-T candidate obe-cel. The 70,000 square-foot building in Stevenage, UK – close to the UK’s CGT Catapult with whom Autolus has an ongoing collaboration – is being built by construction specialist Merit and is set to support Autolus’s lead candidate obe-cel (obecabtagene autoleucel). The chimeric antigen receptor (CAR) T-cell…

November 12, 2021