Our cGMP Facilities

Xellera Therapeutics is a pioneering contract development and manufacturing organization (CDMO) that offers advanced solutions for cell and gene therapy manufacturing. We are the first to receive a CAR-T manufacturing license in Hong Kong and specialize in iPSC, CAR-T, and other immune cell processes. We provide a comprehensive range of services—including cGMP manufacturing, process development, regulatory support, and bioanalytical testing—and deliver innovative solutions. Dedicated to quality and safety, Xellera facilitates the efficient and effective delivery of advanced medicinal therapies to patients.

Grade B Cleanroom for Open Processes in ATP Manufacturing

At Xellera Therapeutics, we pride ourselves on maintaining facilities that meet the highest standards of quality and compliance. Our Grade B cleanroom is specifically designed and equipped to support open processes in the manufacturing of Advanced Therapy Products (ATP). This environment ensures:

  • Strict Contamination Control: Adherence to stringent cleanroom standards minimizes contamination risks during critical open processing steps.
  • Regulatory Compliance: Fully aligned with international guidelines, including US FDA, EMA, and PIC/S standards, ensuring safe and effective product manufacturing.
  • Customizable Solutions: Our Grade B cleanroom is versatile and adaptable to various ATP manufacturing requirements, making it ideal for cutting-edge therapies. 

      By offering Hong Kong’s only Grade B cleanroom facility dedicated to ATP open processes, Xellera Therapeutics remains at the forefront of advanced therapy manufacturing, delivering quality and reliability to our partners.

      Grade-B-Cleanroom

      Grade B Cleanroom

      Hong Kong’s Only Multi-Product cGMP Manufacturing Facility for ATP

      Xellera Therapeutics proudly operates Hong Kong’s first and only multi-product cGMP (current Good Manufacturing Practices) manufacturing facility.

      Our facility is designed to meet the diverse and evolving needs of cell and gene therapy (CGT) production, offering unparalleled flexibility, scalability, and quality assurance.

      Cryogenic Storage
      • Versatile Production Capabilities: Our cutting-edge infrastructure supports the production of a wide range of advanced therapies
      • High-Grade Cleanroom Standards: Equipped with Grade A in B clean spaces, our facility is optimized for open and closed processes, ensuring contamination-free environments for the safe and reliable manufacturing of Advanced Therapy Products (ATP).
      • Multi-Product Capability: Designed to handle multiple products simultaneously, our facility maximizes efficiency while adhering to strict regulatory standards. This makes us the partner of choice for companies seeking streamlined, compliant, and high-quality manufacturing solutions. 

      Integrated In-House Quality Control Laboratory

      Our state-of-the-art in-house Quality Control (QC) laboratory is equipped with cutting-edge analytical technologies to support rigorous testing and ensure compliance with global regulatory standards. Key capabilities include:

      • Flow Cytometry: High-precision cell characterization and immunophenotyping for robust product quality assurance.
      • BacT/ALERT: Automated microbial detection to ensure sterility and safety of cell therapy products.
      • qPCR (Quantitative Polymerase Chain Reaction): Sensitive and reliable genetic testing for identity, purity, and safety of cell-based products.
      • ELISA (Enzyme-Linked Immunosorbent Assay): Comprehensive protein quantification and detection for immune and biological assays.
      • Functional assays, including tumor killing assay, iPSC differentiation,
      • and More: A full suite of advanced analytical methods designed to meet the most stringent requirements for clinical programs.