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| Points to Consider for the General Monograph of Products Rrepared by Recombinant DNA Technology in Chinese Pharamacopeia |
| GAO Kai1, REN Yue-ming2, WAN Lan1, GUO Zhong-ping2, WANG Jun-zhi1 |
1 Chinese National Institute for Food and Drug Control, Beijing 100050;
2 Chinese Pharmacopoeia Commission, Beijing 100061 |
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Abstract Since the first biopharmaceutical—"recombinant human insulin" was licensed by US FDA in 1982, and "recombinant human interferon α1b", the first biopharmaceutical in China was approved in 1989, biopharmaceutical industry has become the fastest growing, most dynamic and technology-intensive field. Good manufacture practice and quality control are key contributions to the safety and efficacy of these drugs. General requirements for the control of monoclonal antibodies are embodied in European and United States Pharmacopeia. Currently there are 12 product categories and 34 monographs embodied in Chinese Pharmacopeia volumn Ⅲ edition 2010. In the coming new 2015 edition, a general monograph of products prepared by recombinant DNA technology is intend to be drafted and included under the directions to further improve drug safety as well as to upgrade the technology level of quality control. This paper is to pave the way for the drafting of monograph of recombinant DNA products from the aspects including scope, manufacture and release control etc.
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Received: 20 January 2014
Published: 25 May 2014
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[1] General monograph: Recombinant DNA technology products. In: European Pharmacopoeia 7.0, 2011: 692-693.
[2] General Chapters: <1045> Biotechnology-derived articles. In: United States Pharmacopoeia 34, 2010.
[3] WHO. Guidelines for assuring the quality of pharmaceutical and biological products prepared by recombinant DNA technology. No.814. http://www.who.int/bloodproducts/publications/WHO_TRS_814_A3.pdf; 1991.
[4] WHO. WHO guidelines on the quality, safety, and efficacy of biotherapeutic products prepared by recombinant DNA technology. http://www.who.int/biologicals/WHO_rDNA_2nd_public_consultation_28_June_2013.pdf; 2013.
[5] European Medicine Agency (EMA). Guideline on similar biological medicinal products containing Biotechnology-derived proteins as active substance: Qualityissues. 22/02/2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003953.pdf.
[6] European Medicine Agency (EMA). Guideline on similar biological medicinal products. 30/10/2005. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf.
[7] European Medicine Agency (EMA). Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 22/2/2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003920.pdf.
[8] WHO. Expert committee on biological standardization. Guidelines on evaluation of similar biotherapeutic products (SBPs). http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf; 2009.
[9] FDA. Biosimilars:questions and answers regarding implementation of the biologics price competition and innovation act of 2009. http://www.fda.gov/downloads/Drugs/Guidances/UCM273001.pdf; 2012.
[10] FDA. Quality considerations in demonstrating biosimilarity to a reference protein product. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf; 2012.
[11] FDA. Scientific considerations in demonstrating biosimilarity to a reference product. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf; Feb, 2012.
[12] ICH. Quality guidelines. Quality of biotechnological products Q5A, viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5A_R1/Step4/Q5A_R1__Guideline.pdf. 23/09/1999.
[13] ICH. Quality guidelines. Quality of biotechnological products Q5B, quality of biothechnological products: analysis of the expression construct in cells used for production of r-DNA derived protein products. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5B/Step4/Q5B_Guideline.pdf. 30/11/1995.
[14] ICH. Quality guidelines. Quality of biotechnological products Q5D, derivation and characterization of cell substrates used for production of biothechnological/biological products. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5D/Step4/Q5D_Guideline.pdf. 16/07/1997.
[15] ICH. Quality guidelines. Quality of biotechnological products Q5E, comparability of biotechnological/biological products subject to changes in their manufacturing process. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf. ICH, 18/11/2004.
[16] 王军志. 生物技术药物研究开发和质量控制.第二版.北京:科学出版社, 2007. Wang J ZH. Development and Quality Control of Biopharmaceuticals. 2rd Beijing:Science Press, 2007.
[17] ICH. Pharmaceutical development Q8. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf. Aug, 2009.
[18] ICH. Quality guidelines. Specifications Q6B, specification: test procedures and acceptance criteria for biothechnological/ biological products. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf. 10/03/1999.
[19] ICH. Quality risk management Q9. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf. 09/11/2005.
[20] ICH. Pharmaceutical quality system Q10. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Step4/Q10_Guideline.pdf. 04/06/2008.
[21] General Chapters: <1046> Cell and gene therapy products. In: United States Pharmacopoeia 34, 2010.
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