Regulatory Gaps Regarding Sugars Used in Injectable Biopharmaceuticals - Are sugars used to stabilize lyophilized proteins appropriate for the end use? - BioPharm International

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Regulatory Gaps Regarding Sugars Used in Injectable Biopharmaceuticals
Are sugars used to stabilize lyophilized proteins appropriate for the end use?


BioPharm International
Volume 19, Issue 5

BETTER GUIDELINES NEEDED


Table 1c. Manufacturing procedures required for active pharmaceutical ingredients and intermediates according to Q7A.10
As previously discussed, most protein-based therapeutics are administered parenterally and oral standards aren't appropriate for excipients used in their manufacture. In spite of this situation, stabilizing excipients manufactured according to API standards are not yet mandated. Although such products have recently become available, formulators are often hesitant to incorporate such new materials not specified in regulatory guidelines; the need for regulatory compliance tends to lock in use of existing ingredients. As growing numbers of new drugs in development are protein-based, it is critical that regulatory guidelines be updated to clarify the situation for manufacturers and reduce risk to their products and patients.

Tom Biere is director of quality assurance and regulatory affairs at Ferro Pfanstiehl Laboratories, Inc., 1219 Glen Rock Avenue, Waukegan, IL 60085, tel 800.383.0126, fax 847.623.9173

REFERENCES

1. Biotechnology Industry Organization, Comments to FDA 2004N-0355. Scientific Considerations. 2004 Dec. 13; 19: 27–29.

2. Shacter E. Well characterized biologicals. Parenteral Drug Association Chapter Meeting; 2003; San Diego, CA. Unpublished observations with written permission from Dr. Shacter.

3. West GB. Adverse reactions of sugar polymers in animals and man. Dep Paramed Sci, North-East London Polytech, London, UK. Progress in Drug Research. 1979; 23:27-50. CODEN: FAZMAE ISSN: 0071-786X.

4. Rafidison P, Ulman K. Strategic Role of Excipients. Pharmabiz (Internet portal). 2004 Dec 2. Available from: http://www.pharmabiz.com/article/detnews.asp?articleid=24928&sectionid=50.

5. FDA Guide to Inspections of Bulk Pharma Chemicals. 1994 May.

6. USP General Informational Chapter <1078>. Good Manufacturing Practices for Bulk Excipients — General Guidance.

7. Cundell AM. Managing the Microbiological Quality of Pharmaceutical Excipients. PDA J Pharma Sci & Tech. 2005 Nov-Dec; 59(6):381-395.

8. Decoding the U.S. Pharmacoepia. Express Pharma Pulse. 2005 June 23. Available from: http://www.expresspharmapulse.com/20050623/oped01.shtml.

9. International Conference on Harmonisation Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, section 2.3.3, Raw Materials and Excipient Specifications, Federal Register Doc. 99–21352, Filed 8-17-99.

10. International Conference on Harmonisation Q7A, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. 2000 November.

11. EP Substances for Pharmaceutical Use (2034).


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