FHB provides several immune system services and cooperates with clinic and health care center to carry out the customized immunoprofiling analysis.
FHB constructs a complete screening platform for circulating tumor cells based on intensive research. We utilize the advanced flow cytometer and epitope-specific monoclonal antibodies to accurately identify circulating tumor cells.
FHB has cooperated and proposed autoimmune cell therapy with several medical centers and clinics. Once received the permission of Center for Drug Evaluation (CDE), patients can be conducted the immune cell therapy in the cooperative medical institution.
FHB constructs a GTP-grade laboratory with advanced cell culture equipment, quality manuals and documents. Furthermore, we set up a TAF-certified testing laboratory to provide a high quality of our cell products.
FHB immune cell bank is satisfied the regulation of GTP. The quality control of immune cell bank is satisfied TAF ISO/ IEC 17025, moreover, the GMP-grade reagents are used for cell preservation. The quality of immune cell bank achieves medical grade for clinical use.
FHB provides customized services of clinical trial management to satisfy each requirement of specific products, such as document preparation for IND, application of IRB/FDA/TFDA, project management of clinical trials, statistical analysis for experimental data, redaction of clinical reports, and quality control of laboratory etc.
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.