GTP Laboratory

The goal

Promote regenerative medicine and cross-field medical research as the goal, with stem cells and immune cells as the main research Topic, and then propose new treatment and prevention technologies and strategies; by integrating basic and clinical research, it is expected to further enhance the core power of the application in Taiwan’s regenerative medicine research and clinical Trial.

Leopard Cell is committed to creating a more dignified life and medical treatment for cancer patients. Therefore, Leopard Cell focuses on strengthening the medical quality and needs of each different patient, and develops stem cells, immune cells, cell therapy, and protein treatment of cancer and other related fields and key Technology, combined with Taipei Veterans General Hospital’s rich experience in hematology oncology, to jointly build a world-class GTP laboratory to carry out a number of cell product development, quality testing and research and development projects to benefit cancer patients

The GTP standards of Leopard Cell – Storage and Cell Processing Unit

  • Lihpao Life Science CORP. integrates ISO9001 and GTP double standards to establish a laboratory quality management and quality assurance system, has a repository that meets GTP specifications, and has multiple certifications and extensions. The clean area for cell processing is set up in accordance with the ISO international standards. The main process area environment is recommended by the Department of Health and set up at ISO level 7; the biological sterile safety operating table is set up at ISO level 5 to ensure that there are no cells in the process. The possibility of cross-contamination or microbial contamination maintains the quality of cells. In the clean area, there is a central control system that monitors all environmental changes in the area, and comprehensive and regular monitoring of temperature, humidity, pressure difference and cleanliness to ensure air quality, maintain process and cell safety.
  • Standardized operating procedures ensure consistent manufacturing processes and ensure cell quality and safety.
    In order to improve laboratory testing capabilities and quality, in addition to using IVD-certified testing instruments with its exclusive quality control liquid, the laboratory’s quality control system has been established, and the ability to participate in relevant domestic and foreign testing projects, such as the College of American Pathologists (CAP) and Taiwan Medical Laboratory Science Association, etc., make the laboratory’s testing capabilities equal to that of international laboratories.
  • Leopard Cell has established a depository for many years, and has accumulated more than one hundred VIP customers for storage, and is actively developing peripheral blood stem cell product applications.

Leopard Cell Human Organ Repository

Leopard Cell Depository was established on August 5, 2010 to develop regenerative medicine compliance, “Human Organ Depository Management Measures” and “Cell Preparation Sites Comply with Good Practices for Good Tissue Practice (GTP)” regulations, and provide stem cell storage services
Based on tumor molecular detection technology, it guides and verifies the screening and research and development of target drugs, actively develops high-end stem cell storage and immune cell therapy technologies, and develops personalized preventive medicine and cell therapy as a blueprint to create “value”
“Chain” medical services

Leopard Cell Cell Processing Unit

Huaxing Biotech (Existing Company), moved to the current site of Tamsui Mangrove since August 2001.
In 2002, with its dendritic cell culture environment that complies with GLP (Good Laboratory Practice) management, it cooperated with Taipei Veterans General Medical to conduct clinical immunotherapy trials for liver cancer. It was the first domestic institution approved by the Department of Health.
Approved, a unit that uses dendritic cells to conduct cancer clinical immunotherapy trials.
Leopard Cell’s GTP laboratory has cutting-edge immune cell culture technology, and in the future will be committed to providing the highest quality cell products in major medical centers.

Blood Tumor Treatment Center

In July 2012, Lihpao Life Science CORP.’s General Manager Wu Hongtai jointly established the “Hematology and Tumor Research and Treatment Center” with Taipei Veterans General Hospital. The main purpose is to develop peripheral blood stem cell transplantation for clinical indications through the cooperation of clinical trials.
Application, expand the application scope of peripheral blood stem cell transplantation; provide early-stage cancer patients and high-risk groups for early stem cell storage, and long-term tracking of the survival rate and activity of stored peripheral blood stem cells to understand the storage and thawing life of transplantation,
To increase the protection of stem cell storage.

GTP Lab-Build a Certification Form

建置認證
1 In accordance with the TFDA No. 0990029978 letter issued by the Food and Drug Administration of the Department of Health of the Executive Yuan on August 5, 2010, the establishment of the Huaxing Human Organ Repository
2 The Food and Drug Administration of the Department of Health of the Executive Yuan conducted an on-site survey of the human organ repository on February 22, 2011 in accordance with the management measures for the human organ repository.
3 In accordance with the letter No. 1001100660 issued by the Department of Health of the Executive Yuan, the blood stem cell depository around Huaxing was approved on April 21, 2011. The results of the on-site survey were in compliance with the management measures for the human organ depository.
4 The Food and Drug Administration of the Department of Health of the Executive Yuan conducted an on-site inspection of the human organ repository on November 25, 2011 in accordance with the management measures for the human organ repository.
5 In accordance with the letter No. 1005049323 issued by the Department of Health of the Executive Yuan, the blood stem cell depository around Huaxing was approved on January 16, 2012.
6 Huaxing’s peripheral blood stem cell depository applied for an additional preservation category (umbilical cord blood), which was approved on January 07, 2013 in accordance with the letter No. 1015048242 from the Department of Health of the Executive Yuan.
Huaxing’s peripheral blood stem cell depository applied for an additional preservation category (umbilical cord blood), which was approved on January 07, 2013 in accordance with the letter No. 1015048242 from the Department of Health of the Executive Yuan. Huaxing peripheral blood stem cell preservation repository application to save an additional category (cord blood), according to the Department of Health Department letter granted fresh word No. 1015048242 on January 7, 2013 approved the license. The original letter of No. 1005049323 dated January 16, 2012 by the Department of Food and Agriculture will be repealed on the date of issuance of the additional license letter
7 In accordance with the letter No. 1045123803 dated January 21, 2015 of the official documents of New Taipei City Government, the name of the institution was changed to Lihpao Life Science CORPORATION.
8 In response to the change of the name of the depository institution and the quality supervisor, it applied for the change of the record in the permit certificate on May 25, 2015, and received the letter No. 1046032086 from the Ministry of Health and Welfare on July 1 to approve the change.
9 This time, in accordance with the letter No. 1015048284 of the Department of Health of the Executive Yuan and the letter No. 1046032086 of the Ministry of Health and Welfare, the Ministry of Health and Welfare submitted an application for the extension of the Lihpao Human Organ Repository
10 According to the letter No. 1046064494 issued by the Ministry of Health and Welfare, the Lihpao Life Science CORP. Human Organ Repository has been incompliance with the Human Organ Repository Management Measures and agreed to extend the license validity until January 6, 2019.
11 This time, in accordance with the letter No. 1046064494 issued by the Ministry of Health and Welfare, the Ministry of Health and Welfare submitted an application for the extension of the Lihpao Life Science CORP. Human Organ Repository.
12 Ministry of Health and Welfare issued letter No. 1076037002, Lihpao Life Science CORP. Human Organ Repository, after the results of on-site inspections, conforms to the Human Organ Repository Management Measures, and agrees to extend the license validity period to January 06, 2022.
13 It is expected that in 2021, the application for the approval of the GTP of the Cell Processing Unit will be applied.