PDA Letter Article

Container Closure Integrity Requires Adaptation

by Dominick DeGrazio, PhD, Janssen R&D, LLC

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The development of biopharmaceutical products is shifting from a traditional platform approach to one comprised of complex modalities like chimeric antigen receptor T-cell therapies, oligonucleotides and oncolytic immunotherapy viruses. This means traditional reliance on a platform comprised of monoclonal antibody (mAb) products may not be adequate for newer, unconventional therapies. Instead, an end-to-end holistic strategy that integrates formulation and package development with manufacturing and administration is necessary to ensure that drug product quality, safety and efficacy are not compromised throughout the shelf life of a product.