Hong Kong-based CDMO becomes the first and only manufacturer authorized to manufacture Virus-Specific T-cell products under a named-patient arrangement.
HONG KONG, Oct 26, 2026 – Xellera Therapeutics Asia Limited (“Xellera”), a Hong Kong-based contract development and manufacturing organization (CDMO) specializing in advanced therapy products (ATPs), has obtained authorization from the Hong Kong Department of Health to manufacture Virus-Specific T-cell (VST) products under a named-patient arrangement.
Xellera is the first and only manufacturer in Hong Kong to receive authorization to manufacture Advanced Therapy Products under a named-patient arrangement, and the first and only manufacturer licensed to manufacture Virus-Specific T-cell products.
These regulatory achievements represent important milestones for Hong Kong’s cell and gene therapy sector, expanding local manufacturing capabilities for specialized immune cell products and supporting clinical partners working with patients who have limited treatment options.
Addressing Viral Infections in Immunocompromised Patients
Virus-Specific T cells are specialized immune cells capable of recognizing and targeting cells infected with particular viruses. VST products can be manufactured from donor-derived blood cells through ex vivo stimulation and isolation to generate T-cell populations that recognize selected viral antigens.
VST-based immunotherapies are particularly relevant to immunocompromised patients, including recipients of hematopoietic stem cell transplantation (HSCT) and solid organ transplantation, who may be at increased risk of serious viral infections.
Depending on the product, VSTs may target viruses such as cytomegalovirus (CMV), Epstein–Barr virus (EBV), adenovirus (AdV), and BK virus (BKV). These products have been investigated and used in specialized clinical settings to manage certain viral infections.
Manufacturing VST products requires careful control of donor starting materials, cell processing, stimulation, and quality control testing to meet product-specific quality and safety requirements.
Establishing VST Manufacturing Capabilities in Hong Kong
The authorization enables Xellera to manufacture VST products within the approved named-patient scope at its licensed GMP manufacturing facility in Hong Kong.
The manufacturing process involves specialized cell handling and controlled production procedures supported by quality assurance and analytical testing to maintain product safety, identity, quality, and consistency.
“Obtaining this manufacturing authorization is an important achievement for Xellera and our technical and quality teams,” said Dr. Camie Chan, CEO of Xellera Therapeutics. “As the first manufacturer in Hong Kong to receive authorization for VST manufacturing under a named-patient arrangement, we are pleased to contribute our expertise to support clinical partners and help establish local manufacturing capabilities for these specialized cell products.”
Supporting the Development of Advanced Cell Therapies
Xellera provides contract development and manufacturing services for cell and gene therapy programs, working with biotechnology companies, academic institutions, and clinical partners.
In addition to VST products, Xellera’s manufacturing and process development platforms support a range of cell-based therapeutic modalities, including chimeric antigen receptor T-cell (CAR-T) products, natural killer (NK) cell-based products, dendritic cell-based products, mesenchymal stem cell (MSC) products, and induced pluripotent stem cell (iPSC)-related processes.
Xellera’s services include process development, technology transfer, GMP manufacturing, and analytical testing. The company works with its partners to establish manufacturing processes appropriate to their products and stages of development.
The VST manufacturing authorization further strengthens Xellera’s capabilities in specialized cell processing and its role in supporting the development of advanced therapy products in Hong Kong.
About Xellera Therapeutics
Xellera Therapeutics Asia Limited is a Hong Kong-based contract development and manufacturing organization specializing in advanced therapy products, including cell and gene therapies.
Operating from a GMP manufacturing facility licensed by the Hong Kong Department of Health, Xellera provides process development, technology transfer, GMP manufacturing, and quality control testing services to biotechnology companies, academic institutions, and clinical partners.
For more information, visit www.xelleratherapeutics.com.
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Xellera Therapeutics Asia Limited
Website: www.xelleratherapeutics.com
Email: [email protected]