Product Clinical Application And Execution

Precision Biotechnology is a cell based new drug company that focuses on clinical research. Its research and development technology focuses on the clinical application of immune cell preparations in cancer, and has a professional team to write clinical trial applications and prepare documents for preclinical research; This includes Chemistry, Manufacturing and Controls (CMC), standard operating procedures, preparation of quality control and quality assurance documents, and literature collection and analysis.

Our collaborative clinical consulting team has more than ten hematology oncologists and cell preparation process experts, with over 40 clinical experiences in executing cell therapy. Whether in terms of regulations or applications from the Hospital Institutional Review Board (IRB), we can provide comprehensive consultation.

Assist in providing implementation plans for special management measures, including:

Medical institutions apply for clinical treatment plans:

  • Cell therapy project, indications, implementation methods, treatment effect evaluation and tracking methods, consent form, adverse reaction notification and relief measures.
  • Precision Biotechnology provides CRO services, assists medical institutions and physicians in writing treatment plans, and can dispatch research nurses to assist physicians in recording treatment outcomes and reporting adverse reactions when necessary.
  • Solve the problem of medical institutions and physicians writing clinical plans and treatment records, in order to focus on the treatment and care of patients.

▼ In December 107, he accepted the commission of Taiwan's cutting-edge medicine and submitted an application for "Autoimmune CIK Cell Technology for the Treatment of Phase IV Solid Cancer" to Hualien Tzu Chi Hospital in January 108. The plan was approved in August 108. This technology is applied to lung cancer, esophageal cancer, gastric cancer, colorectal cancer, breast cancer, liver cancer, brain tumor, and kidney cancer.

▼ In August 108, entrusted by Taiwan's cutting-edge doctors, the application for "autologous immune CIK cell technology for treatment of stage 1 to stage 3 solid cancer that failed standard treatment" was submitted to Hualien Tzu Chi Hospital in September 108. The plan was approved in August 109. This technology is applied to stage 1 to stage 3 lung cancer, liver cancer, esophageal cancer, gastric cancer, colorectal cancer, and head and neck cancer that are ineffective after standard treatment.

▼ Assisted a well-known domestic biotechnology company in applying for implementation in October 108 「Autologous immune CIK cell therapy for stage 4 solid cancer patients」The cell therapy technology was approved by the plan in April 109.

▼ Passed in November 108「Development and research plan for immune cell cryopreservation technology」 application(Zhongqi Zi No. 20909003361)。

▼ Delivered in January 109Zhonghe Hospital Affiliated to Xiong Medical University“ Implement autologous cytokine induced killer(Cytokine Induced Killer, CIK)Cell technology for the treatment of stage 4 solid cancer”Application,The plan was approved in April 110。This technology is applied to esophageal cancer, gastric cancer, colorectal cancer, liver cancer, head and neck cancer, and pancreatic cancer.

▼ Delivered in January 109Kaohsiung Medical University Affiliated Zhonghe Hospital“ Application for autologous immune CIK cell technology in the treatment of stage 1 to stage 3 solid cancer that is ineffective after standard treatment,The plan was approved in June 110.This technology is applied to esophageal cancer, gastric cancer, colorectal cancer, liver cancer, and head and neck cancer.

▼ Assisted in tutoring domestic listed OTC biotech companies in September 109「Autologous immune CIK cell therapy for stage 4 solid cancer patients」CMC and medical plan response documents.

▼ Passed in February 110Ministry of Economic Affairs A+Enterprise Innovation Research and Development Quenching PlanRapid review of clinical trial plans」apply for(Dianhui Zi No. 1100001671).

▼ Delivered in July 110Zhongshan Medical Association Legal Person Zhongshan Hospital“ The application for autologous immune CIK cell technology in the fourth stage of solid cancer,The plan was approved in July 111。This technology is applied to esophageal cancer, gastric cancer, colorectal cancer, liver cancer, head and neck cancer, pancreatic cancer, lung cancer, and ovarian cancer.

▼ Delivered in July 110Zhongshan Medical Association Legal Person Zhongshan Hospital“ Application for autologous immune CIK cell technology in the treatment of stage 1 to stage 3 solid cancer that is ineffective after standard treatment,The plan was approved in July 111. This technology is applied to esophageal cancer, gastric cancer, colorectal cancer, liver cancer, head and neck cancer, lung cancer, ovarian cancer, and breast cancer.

▼ Delivered in August 111Tong Comprehensive Medical Association Legal Person Tong Comprehensive Hospital“ Application for Autoimmune CIK Cell Technology for the Treatment of Phase IV Solid Cancer. This technology is applied to esophageal cancer, gastric cancer, colorectal cancer, liver cancer, head and neck cancer, pancreatic cancer, lung cancer, ovarian cancer, and kidney cancer(applying).

▼ Delivered in August 111Tong Comprehensive Medical Association Legal Person Tong Comprehensive Hospital“ The application for autologous immune CIK cell technology in the treatment of stage 1 to stage 3 solid cancer that is ineffective after standard treatment. This technology is applied to esophageal cancer, gastric cancer, colorectal cancer, liver cancer, head and neck cancer, lung cancer, ovarian cancer, breast cancer, and kidney cancer (applying).

▼ Delivered in August 111Guangtian Medical Association Legal Person Guangtian General Hospital“ Autoimmune CIK cell technology applied for the fourth stage of solid cancer. This technology is applied to esophageal cancer, gastric cancer, colorectal cancer, liver cancer, head and neck cancer, pancreatic cancer, lung cancer, ovarian cancer, and kidney cancer  (applying).

▼ Delivered in August 111Guangtian Medical Association Legal Person Guangtian General Hospital“ The application for autologous immune CIK cell technology in the treatment of stage 1 to stage 3 solid cancer that is ineffective after standard treatment. This technology is applied to esophageal cancer, gastric cancer, colorectal cancer, liver cancer, head and neck cancer, lung cancer, ovarian cancer, breast cancer, and kidney cancer (applying).