BioPharm International, December 2023

Biologics have specific quality considerations that make fast tracking these drugs more difficult.

Preparing for variability and flexible processing are necessary for success.

Digital transformation allows for smarter and connected biomanufacturing operations.

Sufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it.

Pharmaceuticals are entering a transition into a far more complex era of patient therapies, and patient segmentation.

Final product inspection results should be included as part of the batch release documentation, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.