Microbiological Quality Control of Granulocyte-Colony Stimulating Factor (Filgrastim) in Biopharmaceutical Industry

Abstract

The present thesis work aims to describe the microbiological analysis of the recombinant human G-CSF (filgrastim) in pharmaceutical industries. Filgrastim is a human granulocyte colony stimulating factor (G-CSF) produced by recombinant DNA technology. G-CSF regulates the production of neutrophils within the bone marrow; endogenous G-CSF is a glycoprotein produced by monocytes, fibroblasts, and endothelial cells. It is produced by recombinant DNA technology. The gene for human granulocyte colony-stimulating factor is inserted into the genetic material of Escherichia coli. The G-CSF then produced by E. coli is different from G-CSF naturally made in humans. Quality control department of any industry has a very vital role to play in the quality checking before launching of finished products in the market. The newly produced products have to be checked for their constituents, traits and characteristics, shelf life, impurities etc. For any newly designed and produced drug, to be launched into market, we need to test whether it satisfies all the conditions and matches the standard design. So, this qualitative detection is done by following some certain standard operating procedures, to give approval to the product. Quality control includes many different departments. The microbiology quality control department is one of them. Microbiology is critical function and plays a very important role in biopharmaceutical industry. Biopharmaceutical industry mainly focus on the quality of final drug product. That‘s why quality of drug product should be free from microbial contamination. If the drug product is having any kind of contamination it will directly affects therapeutic activity of drug product and it will not work effectively. The quality control section of microbiology includes various kinds of tests which ensures the quality and efficiency of samples and drug product. All the tests are performed under standard operating procedures validated by respective industries. The number of tests such as sterility testing, bioburden testing/ microbial limit test, environment monitoring, and identification of normal flora found in cleanrooms, bacterial endotoxin test, liquid particle count, closed container integrity, water testing performed under microbiology quality control department which ensure the quality of testing material. If testing materials are not complies with the quality criteria, the quality control department doesn‘t permit the release, use or sale of that particular material. The quality control section perform routine activities such as sample Analysis, RM (raw material) & PM (packed material) analysis, Intermediate stage analysis, finished product analysis, calibration of instruments validation, stability maintenance which helps in keeping the laboratory environment sterile and clean. The principle aim behind all tests is to check all parameters of incoming material regarding quality and providing surety for release and sale.