The main components of cellular products are living cells so that they cannot be sterilized, purified, or detoxified at the end of manufacture to eliminate microbial contamination. Therefore, the quality of cellular products is a critical criterion before application. For clinical trials and registrations, rigorous standards for safety control of materials, reagents, and final cellular products, including assessment of sterility and contents of endotoxins, mycoplasmas, and foreign substances, are required.
FullHope Biomedical Co., Ltd. set up a professional laboratory to control the quality of our final cellular products according to rigorous criteria and established analytical protocols applied in this professional laboratory based on the guideline in Chinese Pharmacopoeia, National Standards of the Republic of China, and scientific publications. Taiwan Accreditation Foundation (TAF) certified our endotoxin and mycoplasma detecting protocols with ISO/IEC 17025 in December 2019 and February 2020.
Our laboratory members have profound experience in performing clinical trials, and they continually received train of their performing skills. We also apply certified assessing protocols for quality control to keep the high quality of our cellular products.
TAF certified items: Endotoxin test, Mycoplasma test
| Test items | Assay method and reference | Application |
|---|---|---|
| Endotoxin test | 1. Application Procedures and Review Guidelines for Clinical Trials of Human Cellular Products 2. Bacterial endotoxin assay 3. Chapter <85> Bacterial Endotoxins Test, USP37-NF32 |
Measure endotoxin concentration in cell products or cell culture supernatant |
| Mycoplasma test | 1. Application Procedures and Review Guidelines for Clinical Trials of Human Cellular Products 2. Mycoplasma assay |
Detect mycoplasma contamination in cell products, cell culture supernatant, cell suspension (including cells), and cell wash supernatant. |
