Analytical Method Lifecycle: A Roadmap for Biopharmaceutical Development - The authors propose a roadmap for analytical lifecycle development. - BioPharm International

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Analytical Method Lifecycle: A Roadmap for Biopharmaceutical Development
The authors propose a roadmap for analytical lifecycle development.


BioPharm International
Volume 26, Issue 4, pp. 46-50

ACKNOWLEDGMENTS

The authors would like to acknowledge Ingrid Dheur, biologics director, and Philippe Ledent, process transfer and development manager, for their insightful comments.

Pierre Douette, PhD, is head of GMP quality control at Eurogentec and contributing author to the PDA technical report on analytical method validation and transfer for biotechnology products (TR57); *Pascal Bolon, PhD, is head of sales and marketing for the biologics division at Eurogentec, Rue Bois Saint-Jean, 5, B-4102, Seraing, Belgium.

*To whom all correspondance should be addressed,
.

REFERENCES

1. S.O. Krause et al., "Analytical Method Validation and Transfer for Biotechnology Products," Technical Report 57 (Parenteral Drug Association, 2012).

2. FDA, Guidance for Industry: CGMP for Phase 1 Investigational Drugs (Rockville, MD, May 2008).

3. FDA, Guidance for Industry: INDs for Phase 2 and Phase 3 Studies—Chemistry, Manufacturing, and Controls Information (Rockville, MD, May 2003).

4. EMA, CHMP/QWP/185401/2004: Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials (London, Oct. 2006).

5. EMA, CHMP/BWP/534898/2008: Guideline on the requirements for quality documentation concerning biological investigational medicinal products in Clinical Trials (London, Feb. 2010)

6. FDA, Guidance for Industry: Process Validation: General Principles and Practices (Rockville, MD, Jan. 2011).

7. EMA, CPMP/QWP/848/96: Note for Guidance on Process Validation (London, Sep. 2001).

8. N. Ritter et al., BioProcess Intl. 2 (8), 32-46 (2004).

9. P. Borman et al., Pharm. Tech. 31 (10) 142-152 (2007).

10. P. Hubert et al., J. Pharm. Biomed. Anal. 45 (1), 70-81 (2007).

11. USP Proposed General Chapter <1033> "Biological assay validation," Pharmacopoeial Forum, 35 (2), 349-367 (2009).

12. G. Limentani et al., Anal. Chem. 75 (11), 221-226 (2005).


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