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Genetic stability and recombinant product consistency
D Burstyn1, T Copmann, M Dinowitz
1Biogen, Inc., Cambridge, MA.
Summary
Industry scientists believe current methods adequately ensure recombinant product consistency. They argue against proposed cloning and sequencing measures, citing high costs and minimal benefits for regulatory and industry resources.
Area of Science:
- Biotechnology
- Pharmaceutical Manufacturing
- Regulatory Science
Background:
- Recent proposals from Galibert and the Center for Biologics Evaluation and Research (CBER) suggest cloning and sequencing for ensuring recombinant product consistency.
- A committee of U.S. industry scientists reviewed these suggestions.
Purpose of the Study:
- To evaluate the efficacy and cost-effectiveness of proposed cloning and sequencing measures for assuring recombinant product consistency.
- To present an alternative perspective on current capabilities for ensuring product consistency.
Main Methods:
- Review of industry scientific committee findings.
- Analysis of proposed regulatory suggestions regarding cloning and sequencing.
- Assessment of current analytical and manufacturing technologies.
Main Results:
- Disagreement with the proposed cloning and sequencing measures as a means to ensure product consistency.
- Estimation of significant costs associated with regulatory agency review of artifactual errors and industry resource allocation.
- Assertion that current technologies are sufficient for ensuring recombinant product consistency.
Conclusions:
- The proposed cloning and sequencing measures are deemed unnecessary and overly costly.
- Existing analytical and manufacturing technologies provide adequate assurance of recombinant product consistency.
- Industry scientists advocate for the continued use of current technologies over the proposed regulatory changes.