Reducing Time Not Quality for Biologics Approvals
Biologics have specific quality considerations that make fast tracking these drugs more difficult.
Managing Raw Material Variability for Autologous Cell Therapies
Preparing for variability and flexible processing are necessary for success.
Revolutionizing Biomanufacturing: The Digitalization Advantage
Digital transformation allows for smarter and connected biomanufacturing operations.
Stability Studies: An Essential Step for Quality Management in Drug Development
Sufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it.
The Dislocation of Progress
Pharmaceuticals are entering a transition into a far more complex era of patient therapies, and patient segmentation.
Final Product Inspection: Making the Most of Your Processes
Final product inspection results should be included as part of the batch release documentation, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
