Innovation and continuous improvement in a seemingly accelerated regulatory environment Roger Nosal, Pfizer Inc
April 23-26, 2017
Biopharmaceutical innovation can improve quality assurance, manufacturing capacity & process efficiency. However global regulatory trends are a barrier to continuous improvement and acceleration only exacerbates product development.
While several recent draft guidelines & initiatives1-3 portend to enable innovation, in practice, regulatory expectations reflect increasingly punitive rather than incentive-based opportunities:
• Redundant downstream justification for upstream changes, i.e., stability
• Submission of GMP/supply chain information for review
• Misaligned regulatory review & inspection
• Global regulatory divergence – RSMs, viral clearance, PACs
This presentation describes manufacturing innovations in the context of increasing regulatory demands & under accelerated development timelines.
1Assay Development & Validation for Immunogenicity Testing of Therapeutic Protein Products, Draft Guidance for Industry, FDA/CDER, CBER & CDRH, April 2016.
2Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base, Draft Guidance for Industry, FDA/CDER, December 2015.
3Established Conditions: Reportable CMC Changes for Drug and Biologic Products, Draft Guidance for Industry, FDA/CDER & CBER, May 2015.
Roger Nosal, "Innovation and continuous improvement in a seemingly accelerated regulatory environment Roger Nosal, Pfizer Inc" in "Regulatory Sciences for Biologics and Vaccines: Accelerating Development and Enabling Manufacturing Innovation", Prof. Antonio Moreira (University of Maryland, Baltimore County, USA) Dr. David Robinson (Robinson Vaccines and Biologics LLC, USA) Eds, ECI Symposium Series, (2017). http://dc.engconfintl.org/biologics_vaccines/17