Wednesday, May 11, 2022 Daily Archives

Streamline cGMP Viral Vector Analytical Challenges With Robust and Sensitive Impurity, Fragment Sizing, and Oncogene Quantitation Assays

This webcast features: Jonas Buege, Product Manager, Thermo Fisher Scientific. The therapeutic potential of viral vector-based gene therapies is tremendous, but with some recently adverse outcomes in clinical trials, the safety of these drugs has come into question. Both regulatory agencies and manufacturers are working hard to define appropriate critical quality attributes and identify process-related impurities crucial to ensuring patient safety. These requirements increase the demand of analytical development teams working on viral vectors, over traditional biopharmaceuticals, to utilize novel…

JSR launches services firm for biosimilar development

Newly formed business division Similis Bio will help companies improve efficiency and cost of biosimilar development, says JSR Life Sciences. According to JSR, Similis will provide biosimilar drug developers with solutions to drive development timelines and decrease associated costs. Additionally, Similis will supply partners with data to establish a biosimilar target as well as offering complete analytical and process development packages. The data packages include analytical procedures, product data, process knowledge, and CMC templates from a centralized model created to…

Dover shells out $225m for bio-control instruments firm Malema

Biomanufacturing vendor Dover will bolster its Pumps & Process Solutions segment via the addition of Malema’s single-use flow sensor technology. The $225 million cash deal, expected to close in the second quarter, sees Dover add flow-measurement and control instruments maker Malema Engineering Corporation to its service offering. Malema, which is set to make approximately $40-45 million in sales in 2022, produces single-use flow sensors using Coriolis technology which it claims reduces the potential for measurement error and the need for calibration…