The Asian Integrated Cell Laboratory is the largest autoimmune cell bank around the world. It is the only immune cell and stem cell dual-system clinical cell bank global wide, the first and only FACT standard cell bank in Asia and the only AABB standard cell bank in Hong Kong. Our facilities are implementing the standards set forth by the ISBT128, AABB and FACT. It is the leading international cell drug transformation and application platform, and the leader of cells care in the world. Our first phase project provides world-leading cell test, storage, preparation and application services for 300,000 people worldwide.
The full name of AABB is the American Association of Blood Banks. It is the world’s highest level organization of the Standard Guidelines for Blood Banks and Blood Transfusion and aims at the development of blood transfusion medicine and treatment. This is an international non-profit organization established in 1947, a multinational certification organization with the United States as the core. There are about 1800 institutions such as hospitals, blood banks, and medical centers in more than 80 countries around the world. There are about 8,000 medical workers. The certification permits participation, and all members include doctors and researchers based on the establishment of the highest standard unit of hematology.
As the most authoritative certification currently recognized by the international cell bank, this means that the AABB certified cell bank is not only the equipment, service, safety, infrastructure, and the most excellent quality organization, but this quality also has a continuous guarantee. This is why a stem cell bank with AABB certification is trustworthy.
FACT stands for Foundation for the Accreditation of Cellular Therapy, a non-profit organization co-founded by the International Society of Cell Therapy (ISCT) and the American Society for Blood and Bone Marrow Transplantation (ASBMT) in 1996. The purpose is to conduct inspections and certifications in the field of cell therapy, and to establish standards for high-quality medical and laboratory practices in cell therapy.
The FACT standard was jointly developed by internationally renowned and knowledgeable clinicians, scientists, technical experts, quality experts and cytologists in the field of cell therapy, from cell selection to collection, processing, storage and application, In charge of the manufacturing and management of the world's cells. FACT is the only certification organization that deals with cell therapy, including collection, processing, and management. The goal is to allow safe and effective cell therapy projects to be entered into transformation applications in qualified relevant medical institutions after filing, so that patients around the world can enjoy safer and more Standardized and more effective cell therapy service!
PIC/S is an international cooperation organization called Pharmaceutical Inspection Co-operation Scheme. It is the origin of the most widely used and most prestigious PIC / S GMP in the world. Its purpose is to reach a consensus on the management mode of medicines in various countries, and allow member countries to mutually recognize the results of GMP inspections to avoid duplicate inspections and reduce the resources and costs spent on drug inspection registration and other related drug quality management.
The establishment of PIC/S has made great contributions to unifying international GMP standards, auditing quality systems and standards. So far, PIC/S has 33 members (GMP audit authority), which is the highest standard of international drug standards and supervision and the largest organization.
The full name of the FDA is the Food and Drug Administration (Food and Drug Administration), established in 1906, authorized by the United States Congress, the federal government, is the highest law enforcement agency specializing in food and drug management, is also a world-renowned doctors, lawyers, microbiology A government health control monitoring agency composed of scientists, chemists, and statisticians dedicated to protecting, promoting, and improving national health.
At present, many countries around the world are promoting and monitoring the safety of their own products by seeking and receiving FDA assistance.
FDA's scope of supervision: supervision and inspection of products such as food, drugs, medical devices, food additives, cosmetics, animal food, etc.. Ions and nonionic radiation generated during the use or consumption of products affect human health and safety projects certificate. According to regulations, the above products must be tested by FDA to prove their safety before they can be sold on the market. FDA has the right to inspect the manufacturers and prosecute the offenders.
The FDA's Drug Evaluation and Research Center (CDER) aims to ensure the safety and effectiveness of prescription and non-prescription drugs, evaluate new drugs before they are marketed, and monitor more than 10,000 drugs on the market to ensure that the products meet the constantly updated The highest standard. At the same time, the center also monitors the authenticity of drug advertisements on TV, radio, and publications, strictly monitors drugs, and provides consumers with accurate and safe information.
The FDA has a huge impact in the United States and even the world, and is known as the guardian of American health. Its credibility and professional standards have won the trust of many experts and the general public. Today, the FDA has become a diamond shield in the minds of global food and drug to the consumers.
The full name of CAP is "College of American Pathologists". Its function is to ensure the quality of medical laboratories and improve the quality of laboratory services to patients.
The CAP certification often referred to refers to the accreditation activities carried out by the American Pathological Society for clinical laboratories. The standard of accreditation is the documents developed by CAP itself, mainly referring to the business standards and operating guidelines of the National Clinical Laboratory (NCCLS). The accreditation in clinical laboratories gradually shows an international trend, mainly reflected in the international accreditation system-laboratory accreditation has been widely accepted in the world, ISO15189 came into being.
ISBT 128 is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). It is used in more than 87 countries across six continents and disparate health care systems. It is widely endorsed by the professional community. The standard has been designed to ensure the highest levels of accuracy, safety, and efficiency for the benefit of donors and patients worldwide.
This standard aims to ensure the highest accuracy, safety, and efficiency. It will benefit donors and patients around the world. ISBT 128 provides international consistency, supports the transfer of blood, cells, tissues and organs, traceable blood transfusion or transplantation.
The significance of the ISBT 128 standard is extremely important. It was approved by the ISBT Council in 1994 and is now internationally recognized. Its board of directors for cell therapy products is supported by the boards of AABB, ASFA, ASBMT, EBMT, FACT, ISBT, ISCT, ISCT Europe, JACIE, NMDP and WMDA.
Facilities in more than 87 countries on six continents are registered to use ISBT 128.
Currently, Asia Integrated Cell Laboratory is the only institution in Hong Kong that has obtained ISBT 128 certification in the field of cellular therapy.