The cell production site in Singapore Science Park is close to National University of Singapore, which is closer to headquarter office and convenient for technology transfer and industry-academia cooperation/collaboration. We take the advantage of the well-established investing ambience by the Singaporean government plus a self-disciplinary standard within our company, we have confidence in creating the best solution for the diseased therapies.
Conrad knows the significance of standard in relation to the production, and how various types of certified standards have contributed to ensure the quality of manufacturing sites and cleansing of laboratories. Since issues such as manufacturing methods, facilities, control measures of human cell therapy products, screening and inspection of human cell tissue providers, the collection, processing, storage, labelling, packaging and distribution of human cell tissue are related to the safety of the cell substances made, we have always keep a positive attitude towards full commitment of standards. Nevertheless, we conclude various of standards into three categories: industrial standards, national standards, and international standards. In the bio industry, the laboratory is primarily classified in four different bio-safety-level as BSL-1 to BSL-4. BSL-1 is the lowest level, means bio materials manipulated are unable to cause human disease or illness, and the highest safety of BSL-4 implies to bio materials used in the laboratories has the possibilities to cause lethal and deadly human losses without cures or vaccines available. Second, National standards on the human cells, tissues, and cellular and tissue-based products (HCT/Ps) include regulations of good tissue protocol promogulated by the government. For example, the United States have the Current Good Tissue Practice (cGTP), and Taiwan has human cell tissue good operation Standard or known as Good Tissue Practice (GTP). Last, international standard such as ISO 14644-1, a normative document that sets up requirement for cleanrooms and associated controlled environments such as particle concentration, occupancy states, testing instrumentation, and instrument specifications, and there are 9 ISO class numbers depending on the maximum allowable concentrations. There are other standards such as AABB, AOA, A2LA, CAP, COLA, ASHI and so on.
Conrad is highly experienced in building of the cell production site. Once the production facilities are designed and built, any further modifications will be costly and difficult. Therefore, always planning ahead, and think ahead on the type of inspection and validation by selecting the appropriate GTP or GMP guidelines in the country where the lab is located and cover wide scope of programs to ensure the cell drug manufacturing can be audited in the appropriate quality control and quality assurance programs, which is similar to quality system approach, to control collection, processing, storage and release of cell therapy products.
.jpg)
Conrad knows the significance of standard in relation to the production, and how various types of certified standards have contributed to ensure the quality of manufacturing sites and cleansing of laboratories. Since issues such as manufacturing methods, facilities, control measures of human cell therapy products, screening and inspection of human cell tissue providers, the collection, processing, storage, labelling, packaging and distribution of human cell tissue are related to the safety of the cell substances made, we have always keep a positive attitude towards full commitment of standards. Nevertheless, we conclude various of standards into three categories: industrial standards, national standards, and international standards. In the bio industry, the laboratory is primarily classified in four different bio-safety-level as BSL-1 to BSL-4. BSL-1 is the lowest level, means bio materials manipulated are unable to cause human disease or illness, and the highest safety of BSL-4 implies to bio materials used in the laboratories has the possibilities to cause lethal and deadly human losses without cures or vaccines available. Second, National standards on the human cells, tissues, and cellular and tissue-based products (HCT/Ps) include regulations of good tissue protocol promogulated by the government. For example, the United States have the Current Good Tissue Practice (cGTP), and Taiwan has human cell tissue good operation Standard or known as Good Tissue Practice (GTP). Last, international standard such as ISO 14644-1, a normative document that sets up requirement for cleanrooms and associated controlled environments such as particle concentration, occupancy states, testing instrumentation, and instrument specifications, and there are 9 ISO class numbers depending on the maximum allowable concentrations. There are other standards such as AABB, AOA, A2LA, CAP, COLA, ASHI and so on.
Conrad is highly experienced in building of the cell production site. Once the production facilities are designed and built, any further modifications will be costly and difficult. Therefore, always planning ahead, and think ahead on the type of inspection and validation by selecting the appropriate GTP or GMP guidelines in the country where the lab is located and cover wide scope of programs to ensure the cell drug manufacturing can be audited in the appropriate quality control and quality assurance programs, which is similar to quality system approach, to control collection, processing, storage and release of cell therapy products.