Development of the method for microbiological purity testing of recombinant human interleukin-7-based product

• Published in: Ukrainian biochemical journal 2017-06, Vol.89 (3), p.52-59
• Main Authors: Galkin, O. Yu, Lutsenko, T. M., Gorshunov, Yu. V., Motronenko, V. V.
• Format: Article
• Language: English
• ISSN: 2409-4943; 2413-5003
• DOI: 10.15407/ubj89.03.052

The goal of the work was justification of standardization parameters of the product based on recombinant human IL-7 by “microbiological purity” parameter and development of its measurement method with consideration of the requirements of guideline documents regarding quality of medicinal pro­ducts. Suitabi­lity assessment of microbiological purity testing procedures was performed. It has been established that the studied­ product in standard testing methods possessed antimicrobial activity against test microorganisms Basillus subtilis ATCC 6633 (on soybean casein digest agar and Sabouraud dextrose agar containing an antibiotic), Candida albicans АТСС 10231 (on soybean casein digest agar and Sabouraud dextrose agar containing an antibiotic), and possessed no antimicrobial activity against test microorganisms Staphylococcus aureus ATCC 6538 (on soybean casein digest agar) and Pseudomonas aeruginosa ATCC 9027 (on soybean casein digest agar). The efficacy of lecithin and polysorbate as substances eliminating antibacterial effect in combination with 50-fold dilution of the test sample has been suggested and proven for the purpose of antimicrobial activity neutralization. The developed total aerobic microbial count measurement procedure for the test product conforms to acceptance criteria provided by SPU (2.6.12), and can be used for its microbiological purity control.