By Aaron Chio and Sydney Daniels, Clarkston Consulting
If your company is undergoing a merger, you must juggle operations while ensuring minimal disruptions. You'll need a holistic view of QMS and SOPs to harmonize procedures.
As process intensification is adopted into large scale manufacturing, the responsibility of scale-down models to accurately represent the expanded operating space quickly follows.
The presence of anti-drug antibodies (ADAs) can affect the effectiveness and safety of biologics. Read why regulators emphasize the need for extensive immunogenicity evaluation in biosimilar development.
Three studies cover a product that aims to address unmet needs around the development of subcutaneous drug therapies, including methods for sterilization and a Human Factors evaluation.
