About
Xellera
Founded in 2018, Xellera Therapeutics (“Xellera”), operates Hong Kong’s FIRST commercial current Good Manufacturing Practice (cGMP) facilities for clinical-grade cell and gene therapy products. The brand-new 22,000 ft² state-of-the-art cGMP manufacturing facility with Grade B cleanrooms, quality control, process development and research labs, follow the international USFDA, EMA and PIC/S as well as HK’s local Department of Health standards, specific for the complex manufacturing process of Advanced Therapy Medicinal Products (ATMP) to ensure quality, safety and efficacy.
Rapid Expansion of Cell and Gene Therapy (CGT) Market
- CGT is a revolution of therapeutic innovations in the healthcare and life sciences industry
- Unlike conventional pharmacological (drug) therapies, which are often required throughout the duration of the disease, CGT is designed to be one-off
- Gene therapy involves the delivery of a vehicle to engineer the patient’s gene so as to treat or stop a disease
- Cell therapy involves the transplantation of human cells to replace or repair non-regenerative damaged tissues
How are cGMP and GMP different?
At the most basic level, GMP stands for Good Manufacturing Practice, standards set by regulatory agencies for ensuring the quality and safety of the manufactured drug products; the “c” of cGMP stands for current, designating the most advanced version of GMP with the latest technologies, regulations and rules.
Our CDMO Platform
As a one-stop Contract Development & Manufacturing Organization (CDMO) with our state-of-the-art technology platforms, Xellera accelerates the development and manufacturing of innovative cell and gene products for patients.
