Development of methods and quality standard for quality control of recombinant human GLP-1 analogue fusion protein
- Author:
Chun-Mei HAN
1
Author Information
- Publication Type:Journal Article
- Keywords: HPLC; Leuciferase reporter gene assay; Quality control; Recombinant human GLP-1 analogue fusion protein
- From: Chinese Pharmaceutical Journal 2016;51(13):1085-1090
- CountryChina
- Language:Chinese
- Abstract: OBJECTIVE: To establish the quality control system for the recombinant human GLP-1 analogue fusion protein. METHODS: The potency of the fusion protein was determined by luciferase reporter gene assay. The purity was analyzed by non-reduced SDS-PAGE and SEC-HPLC respectively. RP-HPLC was used for the peptide mapping. ELISA was used to analyze the identification of the final products. The molecular mass and peptide mass spectra were analyzed by LC-ESI-MS technique. Other control tests were performed according to the requirements in the Chinese Pharmacopoeia (Volume III, 2010 edition). RESULTS: Control tests were performed on three different lots of bulks and final products of recombinant GLP-1 analog fusion protein by the developed methods. The results showed that all the indexes met the requirements in the Guideline for Quality Control of Recombinant DNA Products for Human Use and Chinese Pharmacopoeia (Volume III, 2010 edition). The molecular weight of the recombinant human GLP-1 analogue fusion protein was 71 361.0, which was in conformity with the theoretical value. CONCLUSION: The developed methods and standard may assure the safety, effectiveness, and controllability of the recombinant human GLP-1 analogue fusion protein, which might be used for the routine quality control of products of the same kind.
