Protein Sequence Variants, Process Development and Spec Setting Are Generating Queries from EU Biopharmaceutical CMC Assessors

Protein sequence variants have been generating more questions among European CMC regulators in reviewing monoclonal and recombinant product dossiers – joining process development/validation and specification setting as areas where they are often not finding what they need to complete the review.

An informal survey of 20 recent biotech product CMC reviews by Ireland Health Products Regulatory Authority (HPRA) Pharmaceutical Assessor Sean Barry supported his own experience that the amino acid sequence variants has become a recurrent focus of questioning.

Barry reported on the findings of his survey as part of an “update from the EU,” which he provided at the opening regulatory plenary session of the 2016 CASSS CMC Strategy Forum Europe, held in Paris in May.

Also providing updates on their respective agency activity in the biopharmaceutical CMC arena were Center for Drug Evaluation and Research (CDER) Office of Biotechnology Products (OBP) Review Chief Sarah Kennett and Japan Pharmaceuticals and Medical Devices Agency (PMDA) Office of Cellular and Tissue-based Products Principal Reviewer Yasuhiro Kishioka.

The three presenters addressed a similar range of front-burner CMC issues for biotech products, including problems in recent biotech product applications, their respective agency’s accelerated development and review programs, and the shifting approaches and expectations for lifecycle management.

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