A Rational Approach for Setting and Maintaining Specifications for Biological and Biotechnology–Derived Products—Part 2 - The Biologics and Biotechnology Working Group on specifications of

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A Rational Approach for Setting and Maintaining Specifications for Biological and Biotechnology–Derived Products—Part 2
The Biologics and Biotechnology Working Group on specifications of the Pharmaceutical Research and Manufacturers of America presents new approaches to analyzing development and manufacturing data.


BioPharm International
Volume 21, Issue 7

This contradiction has fostered strategies that protect against stability OOS results that have little or negative impact on product quality. A minimalist approach to stability testing is engendered during development, because frequent measurements may result in early OOS results that shorten the apparent shelf life of the product. Often, companies file shelf life limits (which should contain stability measurements through shelf life) that are artificially wide because of adjustment for statistical multiplicity (i.e., the increased probability of failure, with multiple testing; one adjusts for multiplicity by making the interval wider), and are thus unable to capture meaningful changes in product stability. As with release testing, the current environment discourages enhanced designs to study the stability of the final product or to monitor the stability of product on the market. Stability data should be analyzed in a way that promotes data collection to achieve better product understanding.

This risk is likewise borne in validation studies. Samples are taken from multiple locations of the production process, or at multiple levels of a process parameter, and subject to specifications. As with stability testing, in which multiple samples are taken over time, validation samples are subject to excess risk of OOS due to multiplicity, which acts as a disincentive to collecting data for better process understanding.

SUMMARY

The purpose of this paper, which has been developed by the Biologics and Biotechnology Working group on specifications of the Pharmaceutical Research and Manufacturers of America (PhRMA), is to provide guidance on a lifecycle approach to setting global specifications for biological and biotechnology-derived products.

Part 1 of this article, published in the June issue of BioPharm International, included three sections: Terminology, Stages of the Lifecycle of a Product, and Components of a Biological and Biotechnology Product Specification. This part 2 covers the next section, Current Issues Related to the Development of Specifications. The final section, the Suggested Approach for Developing and Maintaining a Total Quality System, will be published in Part 3, in the August issue.

Timothy Schofield is senior director, nonclinical statistics, at Merck Research Laboratories, Merck & Co., West Point, PA, and the corresponding author,
215.652.6801; Izydor Apostol, PhD, is scientific director, analytical and formulation sciences, at Amgen Inc., Thousand Oaks; Gerhard Koeller, PhD, is vice president, quality and compliance biopharmaceuticals, at Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany; Susan Powers, PhD, is biotech quality technology leader, Wyeth Pharmaceuticals, Collegeville ,PA; Mary Stawicki is associate director, regulatory affairs biopharm CMC, at GlaxoSmithKline, Collegeville, PA, and Richard A. Wolfe, PhD, is director and team leader, biopharma operations, at Pfizer Global Manufacturing, Chesterfield, MO.

REFERENCES

12. International Conference on Harmonization (ICH). Q1E, Evaluation of stability data. Geneva, Switzerland; 2003.

13. ICH. Q6A, Specifications for new drug substances and products. Geneva, Switzerland; 1999.

14. US Food and Drug Administration. Guidance for Industry: Investigating out of specification (OOS) test results for pharmaceutical production. Rockville, MD: 2006.

15. Foust L, Diener M, Gorko MA, Hofer J, Larner G, LeBlond D, Lewis J, Sandell D, Schofield T, Vukovinsky K, Warner E. Overcoming disincentives to process understanding in the pharmaceutical CMC environment. Pharm Technol. 2007 Sept;31(9):108–115.


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