Application of a Recombinant Three-Factor Chromogenic Reagent, PyroSmart, for Bacterial Endotoxins Test Filed in the Pharmacopeias
| Autor: | Hikaru Mizumura, Ken-ichi Tanamoto, Norihiko Ogura, Masashi Muroi, Jun Aketagawa, Toshio Oda |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Lysis Serial dilution Population Pharmaceutical Science law.invention 03 medical and health sciences 0302 clinical medicine Bacterial Proteins law Potency education Pharmacology education.field_of_study Chromatography biology Chemistry Chromogenic General Medicine biology.organism_classification Endotoxins 030104 developmental biology 030220 oncology & carcinogenesis Limulus Reagent Recombinant DNA Biological Assay Indicators and Reagents |
| Zdroj: | Biological and Pharmaceutical Bulletin. 42:2024-2037 |
| ISSN: | 1347-5215 0918-6158 |
| DOI: | 10.1248/bpb.b19-00517 |
| Popis: | Assays using lysate reagents prepared from horseshoe crab hemocyte extract (limulus amoebocyte lysate, LAL) are commonly and widely used to detect and measure endotoxin in parenteral drugs and medical devices. However, lysate reagents suffer from lot-to-lot variations leading to possible fluctuations in testing. Also, this continued usage of lysate reagents leads to the possible decline of the horseshoe crab population. Recently, a new recombinant chromogenic reagent, PyroSmart, consisting of three recombinant factors was introduced to the market. There are now three recombinant products; two with recombinant factor C reagents and PyroSmart with the complete recombinant LAL system. We evaluated the applicability of the reagent to the harmonized bacterial endotoxins test in the United States, European and Japanese pharmacopeias. The recombinant product showed equivalent potency of thirteen endotoxins from different bacterial strains to conventional chromogenic lysate reagents as long as their assay modes are identical. All analytical characteristics or assay parameters of the reagent satisfied the acceptance criteria which are set for the use for the bacterial endotoxins test filed in the pharmacopeias. All of 109 parenteral drugs tested can be measured with PyroSmart within respective maximum allowable dilutions. The lot-to-lot variation in recovery of endotoxin added in the parenteral drugs for PyroSmart was equal to or less than those of six limulus lysate reagents. In conclusion, the present study suggests that the recombinant reagent, PyroSmart, provide a good alternative to the LAL reagents with better lot-to-lot variation. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|