Expediting the Technical Transfer of Biopharmaceutical Products - Proper infrastructure ensures equivalent analytical results at all laboratories for a successful simultaneous commercial release from

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Expediting the Technical Transfer of Biopharmaceutical Products
Proper infrastructure ensures equivalent analytical results at all laboratories for a successful simultaneous commercial release from various sites.


BioPharm International


Conclusion

The complexity of the technology transfer analytical methodology dictates most of the aspects of design and acceptance criteria for the transfer protocol. As a reminder, the length of timing between technology transfer training and authentic product release testing must be taken into account and communication continued to provide training refresher support as needed.

The authors are members of the Analytical and Quality Sciences Laboratory, Preclinical Development department, Wyeth Research, 401 N. Middletown Road, Pearl River, NY 10965, 845.602.4981,

References

1. Bioanalytical Method Validation, guidance for industry, USD-HHS, FDA-CDER, FDA-CVM, May 2001.

2. Text on Validation of Analytical Procedures, ICH guidelines Q2A, 27 Oct 1994.

3. Validation of Analytical Procedures: Methodology, ICH guidelines Q2B, 6 November 1996.

4. Specifications: Test Procedures and acceptance criteria for Biotechnological/Biological Products, ICH guidelines Q6B, 10 March 1999.

5. Scypinski S, Roberts D, Oates M, Etse J. Analytical Method Transfer, draft guideline, Pharmaceutical Research and Manufacturers Association (PhRMA) Acceptable Analytical Practices, Pharmaceutical Technology Europe, March 2002.

6. Krause SO. A guide for testing biopharmaceuticals-Part 1: general strategies for validation extensions. Pharmaceutical Technology Europe, May 2006.

7. Lutz H. Introduction to Validation of Biopharmaceuticals, BioPharm International, March 2005.

8. European Pharmacopoeia, 5th Ed. 5.5, Assay Method 2.5.12

9. The Japanese Pharmacopoeia, 14th Ed. Part 1, General Test 10.


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