1. European Directorate for Quality Medicines & Healthcare (EDQM). Recombinant DNA technology products of. In: EDQM. General Monograph, European Pharmacopoeia 7.0. Strasbourg, France: EDQM, 2011: 692–693
2. Wang JZ. Development and Quality Control of Biopharmaceuticals. 2nd Ed. Beijing: Science Press, 2007:76–77 (in Chinese)
3. Li XY, Wang HG. Advance the Biotechnology, Leading the Bioeconomy. Beijing: China Medical Science Press, 2005: 8–20 (in Chinese)
4. http://www.fda.gov/downloads/ForIndustry/UserFees/Prescription-DrugUserFee/UCM164641.pdf (Access on January 18, 2012)
5. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/How-DrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080402.htm (Access on January 18, 2012)