Cellogx
Cellular and tissue products require specialized facilities, honed quality systems and highly trained technicians to ensure the highest level of product quality with maximum cell and tissue viability. Cellogx has built an operation and custom designed facility focused on these core concepts.
Our experienced staff undergoes an extensive training program that is designed to transfer the knowledge and subtleties relating to every aspect of each product in our facility. With over 50 years of cellular and tissue experience, the Cellogx team is dedicated to the processing, cryopreservation, storage and distribution of high quality aseptic cellular products, as well as the storage and distribution of tissue products.
Cellogx’s new facility provides separate state-of-the-art processing stations, a gravity fed liquid nitrogen cryogenic storage facility with capacity to house over 1 million vials of stem cell and tissue products, and a distribution facility capable of shipping stem cells under liquid nitrogen or dry ice conditions throughout the world. The Company’s redundant monitored storage facility is considered a showcase for the industry, with leading-edge capabilities found in only a few cryogenic facilities in the world. Cellogx is registered with the FDA for a number of functions including processing, storage and distribution of human cells, tissues and cellular and tissue-based products (HCT/Ps) and holds all requisite licensures. This new facility provides ample capacity to support the Parcell Group’s growing operations, as well as the needs of independent institutions and companies seeking professional and reliable cellular and tissue services.
Cellogx employs a Quality System approach that ensures cGTP/GMP compliance in critical areas including:
- Training and Qualification
- Validation of all processes to ensure aseptic manufacturing of stem cell products
- Materials, equipment and facilities controls
- Deviation and Corrective and Preventative Action protocols
- Document controls
- Internal and external auditing
- Policies/procedures for donor screening in accordance with 21 CFR 1271.75
- Policies and procedures for testing as per 21 CFR 1271.80 and 1271.85 to reduce the risk of transmission of relevant communicable diseases
For more information, contact Tim Beals, President of Cellogx, at (508) 545-2990.