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Clinical-grade CAR-T Cell Manufacturing

Chimeric antigen receptor (CAR) T cell therapy is a revolutionary cancer treatment. The recent successes of CAR-T cell therapy have resulted in a fast-growing number of CAR-T clinical trials for haematological and non-haematological malignancies globally.

Decade-long remission of the first cancer patient with end-stage leukemia who received CAR-T. Nature 2022

For now, HK patients need to fly to the US or other oversea sites for CAR-T infusion and hospitalization. Or patients need to freeze their blood, ship overseas for CAR-T production (cost at ~US$400k), freeze CAR-T, ship back then thaw for treatment, compromising time and efficacy. Patients had died while waiting.
NO approved or qualified facility in HK to manufacture CAR-T until now
 
> 400,000
no. of cancer patients in HK~ 35,000
no. of new cancer patients per year in HK

7.5M vs 86M
HK vs GBA populations

 
Xellera’s CAR-T manufacturing platform is highly flexible and SCALABLE
 
NO approved or qualified facility in HK to manufacture CAR-T until now
> 400,000
no. of cancer patients in HK
~ 35,000
no. of new cancer patients per year in HK
7.5M vs 86M
HK vs GBA populations
Xellera’s CAR-T manufacturing platform is highly flexible and SCALABLE

Recent successes of CAR-T therapy have resulted in a fast-growing number of CAR-T clinical trials for haematological, other malignancies and solid tumors globally. To generate CAR-T cells, T cells are isolated from the patient’s own blood and genetically engineered to express a chimeric antigen receptor (CAR) for recognising the specific cancer cell antigens. The CAR-T cells are then given back to the patient by infusion, where effectively target and destroy the cancerous cells.

The manufacturing process of CAR-T cells need to be done in a cGMP-compliant facility that is approved by drug regulatory agencies such as USFDA, EMA and HK’s Department of Health. Xellera is the first cGMP facility in Hong Kong to manufacture clinical-grade CAR-T cells. Using the CliniMAC Prodigy Platform developed by our partner Miltenyi Biotec, we produce CAR-T products in an automated and standardized process to make this latest cancer treatment accessible to the local and regional communities. Users of our CAR-T include the Department of Paediatric and Adolescent Medicine of Queen Mary Hospital and the Children’s Hospital of Hong Kong.

Contact your oncologist or our specialist if you are interested in CAR-T.

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iPSC Haplobank

Induced pluripotent stem cells (iPSC) can become all cell types, including non-regenerative heart and brain cells for regenerating or repairing damaged organs or tissues. iPSC-based immunotherapies are also being developed for treating different cancer types. Therefore, iPSC is an integral part of cell therapies as the ‘raw materials’. Similar to transplantation, a key consideration is to overcome immune rejection due to mismatched donor and recipient, highlighting the importance of an iPSC haplobank, which is a collection of iPSC lines derived from individuals who are homozygous for the most common haplotypes in the population to provide a match for Human Leukocyte Antigen (HLA) system, which encodes cell surface molecules specialized to present antigenic peptides to the receptor on T cells. The establishment of an iPSC haplobank can provide a ready supply of iPSCs with haplotypes that can be closely matched to individual patients in need of these cell therapies.
A number of iPSC haplobank initiatives have been established around the world, including the US, Japan and Korea.  Xellera has initiated the first iPSC haplobank project in Hong Kong in collaboration with local and overseas parties including the Hong Kong Red Cross Blood Transfusion Service, the University of Hong Kong & Queen Mary Hospital, Scottish National Blood Transfusion Service and the University of Edinburgh.

The Global Alliance for iPSC Therapies, is a consortium of organizations including the New York Stem Cell Foundation (New York, USA), the Cell and Gene Therapy Catapult (London, UK) the Centre for Commercial-ization of Regenerative Medicine (Toronto, Canada), the Korean HLA-Typed iPSC Banking Initiative (Seoul, Korea), the French Institute of Health and Medical Research INSERM (Paris, France), and the University of Hong Kong (Hong Kong, Hong Kong) whose aim is to supports the implementation and clinical application of therapies derived from induced pluripotent stem cells to the benefit of patients globally. More information on GAiT is available in this recently published open access article here.

As a member region of GAiT, Xellera’s iPSC reprogramming and production methodology are in accordance with GAiT guidelines. Our iPSC manufacturing process is compliant with regulatory guidelines set by the FDA, EMA and PICs. Contact us for more details on how the iPSC haplobank can benefit you.

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Mesenchymal Stem Cells

Mesenchymal stem cells (MSCs), also known as mesenchymal stromal cells, are multipotent adult stem cells which can be found in tissues including umbilical cord, bone marrow and fat tissue. These cells possess high self-renewal capacity and can be differentiated into multiple cell types such as bone cells, cartilage cells, muscle cells, fat cells, liver cells and other connective tissues. MSCs also secretes a number of bioactive factors that can further contribute to their use in regenerative medicine and tissue repair, including bone regeneration, cartilage repair.

MSCs also produces immunomodulatory molecules that can inhibit the immune system and produce anti-inflammatory effects. This makes MSCs useful for treating a number of indications as immune tolerant agents including graft-versus-host disease (GVHD), autoimmune and inflammatory diseases (Crohn’s disease, etc).

At Xellera, our MSCs are isolated from a number of different sources, including but not limited to umbilical cord, bone marrow and adipose tissue. With our standardized, cGMP-compliant manufacturing process, we then expand these MSCs to provide the highest quality and most affordable MSCs suited for different clinical applications.

Contact us if you are interested in our MSC manufacturing technologies.

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