The process planning team of the precision biotechnology cell production plant can provide a comprehensive production and quality control process for rabbit plague cell preparations, including (1) instrument and environmental planning, (2) process quality document preparation, (3) product quality testing, and (4) process technology transfer.

We have GTPCompliant with GTP specifications   I have experience in manufacturing processes and comprehensive quality procedures, as well as experience in guiding GTP production laboratories and CPU factory inspections in clinical trials of cell therapy.

Under the highest principle of ensuring the quality and safety of cell preparations, the stability and consistency of cell products are supported based on the process validation of different batches. And can customize the process and establish analysis projects according to customer needs. Precision Biotechnology has a strong technology think tank team, which will establish standardized inspection and analysis projects and acceptance standards according to customer needs, and provide appropriate quality assurance.

▼ In October 107, the technology was transferred to cutting-edge medicine in Taiwan

The cooperation agreement between precision biotechnology and cutting-edge medicine is signed, and the education and training of personnel are planned, as well as the establishment and revision of quality documents. The preparation of CMC for trial production is completed to meet the quality standards of cell preparations that meet the specifications.

▼ In January 108, I coached cutting-edge doctors in Taiwan to undergo TFDA GTP visits and passed them in June of the same year

Precision Biotechnology and Clinical Trial Cases「Phase I open trial clinical trial, EGFR mutation in advanced non-small cell lung cancer patients, treated with EGFR-TKI (Gefitinib or Erlotinib) standard, combined with PB101 immune cell preparation for safety and tolerance evaluation. The second production base was established by a cutting-edge medical factory, and on-site visits were conducted through TFDA. Wei Shu Shi Zi No. 1086015872 issued by the Ministry of Health and Welfare」Approval.

▼ In July 108, I coached cutting-edge doctors in Taiwan to undergo a CPU audit by the Medical Affairs Department and passed it

Precision Biotechnology Guidance for Advanced Medical Development and Application to Hualien Tzu Chi Hospital「Autologous immune cell CIK therapy/solid cancer stage 4」The cutting-edge medical CPU factory completed an on-site inspection of cell therapy medical technology in July. And in August of the same year, obtained a health production site and operation permit from the Ministry of Health and Welfare「Wei Bu Yi Zi No. 1080023730A」

In August 109, I assisted domestic listed biotech companies in providing guidance on the preparation for GTP screening for "autologous immune CIK cell therapy for stage 4 solid cancer patients".