Manufacture and quality control of follicle stimulating hormone products
- Author:
Chun-Xue YANG
1
Author Information
- Publication Type:Journal Article
- Keywords: Follicle stimulating hormone; Manufacture; Preparation; Quality control
- From: Chinese Pharmaceutical Journal 2014;49(7):529-533
- CountryChina
- Language:Chinese
- Abstract: OBJECTIVE: Follicle stimulating hormone has been taken as an essential component in the management of infertility. Herein we reviewed the development history of FSH preparations to provide experience and lessons for the research of new FSH preparations, and give an example for the development of other gene medicine. METHODS: The manufacturing techniques and quality control methods of routine FSH preparations were summarized, and the key problems for the preparations were discussed. RESULTS AND CONCLUSION: The history of developing safe and effective FSH preparations was full of challenges of efficacy, safety and the pa-tients' compliance, etc. A series of problems of FSH preparations, such as low efficacy and immunogenicity of animal-sourced FSH preparations, safety of human cadaver FSH, and low purity of urinary FSH, have constantly facilitated both the reformation of manufacturing techniques and improvement of quality control methods of FSH preparations. With the introduction of recombinant DNA technology, recombinant FSH preparations of high purity and consistency are now available, which are safe and effective, and long-acting FSH preparations have improved the compliance of patients.
