Innovation and continuous improvement in a seemingly accelerated regulatory environment Roger Nosal, Pfizer Inc

Conference Dates

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1Assay Development & Validation for Immunogenicity Testing of Therapeutic Protein Products, Draft Guidance for Industry, FDA/CDER, CBER & CDRH, April 2016.

2Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base, Draft Guidance for Industry, FDA/CDER, December 2015.

3Established Conditions: Reportable CMC Changes for Drug and Biologic Products, Draft Guidance for Industry, FDA/CDER & CBER, May 2015.

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