About Us

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Our experienced professionals have a deep understanding of the complex landscape of Cell/Gene Therapy and the production of clinical grade cellular therapies. We offer a range of services to support our clients at every stage from early development to regulatory affairs and clinical applications. Over more than 20 years, our members have contributed to the development of:

Clinical Bone Marrow Transplantation and Cell Therapy Programs:  upgrading capabilities of Cell Processing Laboratories to support various clinical protocols.

• Beyond conventional processing of Bone marrow, Leukapheresis, and cord blood, we have improved capability of Hematopoietic Stem Cell transplantation (HSCT) Labs to perform more complex manipulations including cell selection or depletion using MACS Technology based on surface markers  (CD34,  CD56, CD19, CD3, CD45RA, and/or TCR alpha/beta).
• CMC writing to support IND submissions of HSCT clinical protocols.

Centers for Cell Collection, Storage, and banking

• Introduced best practices for collection, management and cryopreservation of therapeutic cells from various sources (Bone marrow, cord blood, Peripheral blood Cytapheresis, adipose tissues, dental pulps, and perinatal tissues).
• Supported the establishment of Public and Private Cord blood and biobanking Programs 

Accreditation: improved operational capacity and quality management systems for Cell therapy and Cell Banking facilities to fully comply with the US regulations and accreditation standards set by FACT, AABB, and CAP.

Immunotherapies: developed advance cellular therapy products for experimental clinical trials including Viral specific T cells, T regulatory cells, Natural Killer cells, Tumor infiltrating Lymphocytes, and various versions of CAR-T cell products.

Regenerative therapies: we developed various clinical grade regenerative cellular products such as hematopoietic stem cells, Mononuclear cells and Mesenchymal stromal cells (BM, Adipose, umbilical cord).

Cell engineering and Product’s testing:

• Developed methods for cell selection, Ex vivo expansion, activation, and lentiviral gene transfer
• Developed product’s release criteria and test methods to assure safety, identity, purity, and strength/potency