- Transcell is state of the art stem cell banking and processing centre
- Transcell is highly equipped with expertise and optimal microenvironment for processing and preserving your child's precious stem cells for all the potential future medical requirements
- Personal commitment from enrollment, collecting the source, processing the stem cells, cryopreserving the customized stem cell units for future therapeutic options, reporting associated with safe service delivery
- Stringent quality control and quality assurance ensured
- Standard operating procedures and automated processing protocols followed
- On average, the process employed recover over 90% of total nucleated cells and high density of mesenchymal stem cells from the sample
- Initial quarantine
- Long-term storage in liquid nitrogen maintains temperatures at -196 Degree C, far below the recommended minimum standard for storage at -150 Degree C
- Samples are stored in an fire and earthquake proof vaults with 24x7 monitored ambience
- Emergency UPS, Access restriction systems and Backup arrangements installed
GMP Manufacturing Capabilities
Transcell's controlled Heating, Ventilation and Air Condition ensures the safe keeping of the material stored, supports the equipment employed, and provide a safe and effective working environment for the staff. The design includes sufficient space to accommodate the material planned for initial as well as future storage and also provide for the safe movement of people, equipment and specimens, as needed or as required by law. The Facility has Emergency UPS, Backup arrangements and Fired safety standards installed with Access restricted and 24x7 monitored infrastructure.
Processing Facility consists of a preculture specimen acquisition suite, Class 10,000 suite, Class 100 set up and two associated Cryopreservation suites with decontamination corridor. The material and men movement is segregated for the best cell culture practice. This facility is equipped with the following:
Mechanical Freezers, Class 100 cabinets ,Stem cell Processors, Cell Separators, Water Bath, Refrigerated Centrifuges, Vapour Phase Liquid Nitrogen Freezers, Ambience Oxygen Sensors, Storage Containers, Phase Contrast Microscopes, Room Temperature and Humidity monitors, Pressure Monitors, Refrigerators, System in place for the Calibration and Functionally of the equipment, Standard Operating Procedures manual(of the Equipment and the Stem Cell Processing procedures) , CO2 Incubators
GMP Processing & Formulating of Stem Cells with Repository Facility
Transcell Biologics is a GMP contract manufacturing organization offering a fully integrated range of services in Stem cell processing and Formulating. Transcell supports hospitals in process development, through clinical trials.
Transcell is the only GMP Stem Cell Processing Unit in India located at Hyderabad, A.P that manufactures both clinical and commercial cell products. Transcell can therefore offer not only GMP manufacturing for Phase I and II clinical trials, but also scale-up and production for Phase III and commercial supply, thus avoiding the need for a costly and time consuming technology development at your institute.
Transcell has extremely diverse experience in Stem Cell Processing, Expansion, Formulating and Cryopreservation. Transcell's GMP Processing capabilities include GMP compliance, Cell Culture Facility, QC Testing Capabilities, QA Release. Transcell offers a broad range of Stem Cell Processing services, which includes process development, batch wise stem cell expansions for clinical trials. Transcell's Qualified Persons (QP) and the Quality Assurance team work closely with Institutes, Hospitals and Institutional Ethics Committees (IEC) to ensure that any potential issues are brought to light and are addressed appropriately within the work program, as well as providing relevant and appropriate documentation and data in a timely manner.
QC Testing Capabilities
Following the GMP processing of Stem Cells, Transcell's QC team completes a diverse range of microbiological, endotoxicity tests of the facility as well as the process enabling batches to be GMP released by Transcell biologics is part of quality affairs and is independent from the Processing department
Following the completion of GMP manufacturing, one of Transcell's QPs will release the Certificate of Description.