Our Services
Process Development Services
Custom Manufacturing Services
The development of an efficient manufacturing process is critical to ensure that safe and high-quality cell and gene products are available for the patients as approved registered therapeutics or experimental medicine for clinical trials. Xellera has a portfolio of solutions for early-stage development all the way to larger-scale commercial production. With our in-house capabilities, we provide you with the infrastructure with hardware, software and expertise for a scalable, robust manufacturing process so as to efficiently take your cell- and/or gene-based therapeutic product to the patients.
iPSC Manufacturing Service
Establishment of 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 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) and the French Institute of Health and Medical Research INSERM (Paris, France) whose aim is to support 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 our R&D and GMP iPSC manufacturing services and iPSC banks.
CAR-T Cell Manufacturing Services
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.
Xellera is the first to receive the manufacturing license for producing CAR-T cells in Hong Kong. We offer bioanalytical and process development expertise to optimize and scale up your CAR-T manufacturing. With in-house testing capabilities at our state-of-the-art facilities, we ensure rigorous bioanalytical assay development and quality control, allowing us to expedite your journey toward transformative therapies.
Virus-Specific T Cells
Viral infections are common and are potentially life-threatening in patients with moderate to severe primary immunodeficiency disorders. Virus-Specific T Cells (VST) are a form of adoptive immunotherapy designed to treat or prevent severe viral infections, particularly in immunocompromised individuals.
VSTs are derived from a donor’s blood and expanded ex vivo to target specific viral antigens. Common viral targets include adenovirus (ADV), cytomegalovirus (CMV), and Epstein-Barr virus (EBV). Their precision and adaptability make them an ideal therapy for treating viral infections, particularly in patients who have undergone hematopoietic stem cell transplantation (HSCT) or solid organ transplantation.
Our processes are being developed to target a range of opportunistic viral infections, including:
- Cytomegalovirus (CMV): A common and potentially severe infection in immunocompromised patients.
- Epstein-Barr Virus (EBV): Associated with post-transplant lymphoproliferative disorders (PTLD).
- Adenovirus: A significant cause of morbidity and mortality in pediatric transplant patients.
- BK Virus: Known to cause nephropathy in kidney transplant recipients.
Mesenchymal Stem Cells
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 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.
Others
We offer GMP manufacturing for a range of cell and gene therapy products, including NK cells and dendritic cells. Our flexible and scalable manufacturing solutions ensure compliance with global regulatory standards, supporting both autologous and allogeneic therapies.
We welcome custom manufacturing inquiries and are committed to providing high-quality, efficient, and cost-effective solutions to meet diverse therapeutic needs.
Quality Control/Release Testing
We uphold the safety, purity, and potency of cell therapy products through comprehensive bioanalytical testing, meeting regulatory compliance, and maintaining quality throughout development and manufacturing. Our in-house allows fast and efficient product release.
Bioanalytical Development Services
Our Bioanalytical Development Services provide comprehensive solutions to support the development, validation, and implementation of robust analytical methods tailored to your unique needs. We focus on ensuring quality, reliability, and compliance across every stage of product development and manufacturing.
Bioanalytical Testing
Cell-based therapeutic products have a limited shelf-life. Xellera Therapeutics provides in-house testing services for cell and gene therapy products covering characterization, safety, purity and functional testing for starting and raw materials as well as in-process and finished products. These bioanalytical tests are crucial for allowing fast and efficient product release.
