Our ISO-7, Class 10,000 Good Manufacturing Practice or GMP laboratory has been specifically designed for stem cell processing. GMP is a term recognized worldwide for the control and management of manufacturing and quality control testing of pharmaceutical/biological products and is held to the highest standard by the FDA.

The clean area, which is the production area, has two self-contained tissue suites equipped for the processing and expansion of patient’s stem cells.

Many features have been incorporated into the design of this facility to minimize the risk of cross-contamination between products. Some of the specifications of these areas include: unidirectional traffic flow, single-pass HEPA filtered supply air and 100% exhaust from the biological safety cabinets through dedicated ducts.

The walls, ceilings and floors are coated with distinct compounds to minimize contamination from outside particulate material.  Contiguous to the clean area, there is an ante-room used for gowning and storage of supplies in route to the clean areas. An adjacent main lab is used for quality control testing and the receipt and storage of cell culture materials. 

The clean area is equipped with sophisticated tissue culture incubators used during stem cell expansion and reserved for one-donor/one-chamber use. Thus, cells for individual clients/patients can be processed without risk of cross-contamination. 

We comply with FDA requirements for the maintenance of equipment, cleaning of laboratory setting, and the standardization of equipment. 

All major equipment is on a remote alarm system that automatically contacts our staff when/if conditions should fall outside the accepted limits.

Cyropreservation Lab

For cryopreservation of critical cell products, TCA Cellular Therapy has built a new facility equipped with Controlled Rate Freezing and Liquid Nitrogen (LN2) Storage systems.  The CBS 2100 Controlled Rate Freezing System, a fully computerized instrument, eliminates all variables associated with ultra low freezing to ensure maximum cell viability.   Cells under storage, both for short-term  and long-tem periods are preserved in CBS Isothermal freezers which provides ultra low storage temperatures (-190 degree C range)without contact of liquid nitrogen in the sample storage space.  This unique system eliminates the need to submerge samples in liquid nitrogen, thus eliminating the possibility of sample cross contamination.

Our sophisticated cryopreservation facility, LifeSource Cryobank, LLC, assures not only cryopreservation and ultra low temperature maintenance of a diversity of cells, but also a healthy return to normal conditions of temperature to ensure a successful transplant.  

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