Newsletter | May 16, 2024

05.16.24 -- Integrating Quality Processes And Documentation After A Merger


Integrating Quality Processes And Documentation After A Merger

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.


A Model To Increase Yield In mAb Cell Culture Perfusion At Large Scale

As process intensification is adopted into large scale manufacturing, the responsibility of scale-down models to accurately represent the expanded operating space quickly follows. 

Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars

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.

Evaluating The Impact Of Sterilization Methods On Stopper Performances

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.


Committed To Quality, Collaboration, Service, And Innovation