Xellera Therapeutics has built an advanced therapies development and manufacturing facility that complies with international cGMP standards for the development of advanced therapeutics in Hong Kong . We are committed to provide excellent cGMP manufacturing to our clients.
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Clinical-grade CAR T cell manufacturing via viral transduction
Chimeric antigen receptor (CAR) T cell therapy is a revolutionary cancer treatment. The recent successes of CAR T cell therapy has resulted in a fast-growing number of CAR T clinical trials for haematological and non-haematological malignancies globally.
n CAR T cell therapies, T cells are taken from the patient’s blood and modified at the cGMP facility by adding a gene coding for a man-made receptor called chimeric antigen receptor (CAR), which helps them better identify specific cancer cell antigens. The CAR T cells are then given back to the patient through transfusion.
Using the CliniMAC Prodigy Platform developed by our partner Miltenyi Biotec, our CAR T products are generated in a standardized and automated process. Our current CAR T product include CD19-targeted CAR T-cells for treatment of refractory/relapsed B-cell lymphoma/leukaemia. The great potential of genetically modified T cells now expands into solid tumors and other infectious diseases. We will introduce additional CAR T products targeting other antigens including CD20 and CD22 in the near future to address other types of cancers. Contact us for a partnership to develop these novel CAR T therapies.
Clinical-grade iPSC manufacturing
Induced pluripotent stem cells (iPSC) can be differentiated into all tissue and cell types in the body. iPSC provides the ‘raw materials’ for novel therapeutic approaches to regenerate or replace functionally impaired tissues. Cells including heart cells, brain cells, retinal pigment epithelial (RPE) cells and pancreatic beta cells can be derived from iPSCs to treat various diseases including heart failure, Parkinson’s disease, macular degeneration and diabetes. iPSCs-based immunotherapies are also being developed for treatment of different types of cancers.
At Xellera, we are building the first cGMP grade iPSC haplobank in the region, catering for the Southern Chinese population, with the ability to create iPSC Master Cell Bank, iPSC expansion, validation, and differentiation. Our manufacturing process is consistent with regulatory guidelines set by the FDA, EMA and PICs. Contact us for more details on how iPSC reprogramming can benefit you.
Clinical-grade MSC manufacturing
Mesenchymal stem cells (MSCs) are multipotent adult stem cells which are commonly found in tissues including umbilical cord, bone marrow and fat tissue. This subset of cells possesses high self-renewal capacity and can be differentiated into multiple cell types such as bone, cartilage, muscle, fat cells and other connective tissues. MSCs are currently being developed as therapies for a number of indications including graft-versus-host disease (GVHD), autoimmune and inflammatory diseases (Crohn’s disease, etc.), heart failure, solid organ transplantation, liver or kidney failure, and bone diseases. Our standardized manufacturing process for MSC is compliant to cGMP standards with validation results to ensure safe, consistent and affordable MSC products for clinical applications.