Andrew Bulpin, head of Process Solutions, MilliporeSigma, shares insights on characterizing CQAs in biopharmaceutical development and the different tests that should be carried out when assessing an investigational drug.
Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.
Process analytical technology tools have enabled manufacturers to monitor and control their production processes.
Robust materials management, supplier quality management, quality control, and business continuity planning are essential to ensure continuous supply of single-use bags.
Advances in wearable devices have made it possible to deliver high-volume, high-viscosity biologics.
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
Siliconization is a key process step in the manufacturing of prefilled syringe systems.
There is a lot of interest in delivering biologics via non-invasive routes in attempt to improve patient compliance and convenience.
OrlaSURF technology can be used for the development of target-binding assays to monitor the binding of an ADC to its antigen.
Andrew Bulpin, head of Process Solutions Strategic Marketing & Innovation at MilliporeSigma spoke with BioPharm International about the requirements of expression systems in biosimilar development.