GLP Drug Safety Testing Center

GLP Drug Safety Testing Center

The first-of-its-kind Drug Safety Testing Center (DSC) is a new HKSTP initiative to facilitate the translation of promising therapeutics and medical devices from the preclinical phase to the clinical stage.

Good Laboratory Practice (GLP) and AAALAC International Accreditation

A drug candidate must first be proven safe before entering clinical trials.

Good Laboratory Practices (GLP) is the managerial quality control system that covers entire organisation and testing procedures to ensure quality, uniformity, consistency, reliability and reproducibility.

DSC follows US FDA GLP requirements. DSC is going to apply for GLP certification from NMPA and OECD.

AAALAC International promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. More than 1,100 companies, universities, hospitals, government agencies and other research institutions in 50 countries/regions have earned AAALAC accreditation, demonstrating their commitment to responsible animal care and use.

In March 2024, DSC received AAALAC International’s full accreditation decision. All study plans conducted in DSC are required to seek approval from the Institutional Animal Care and Use Committee (“IACUC”) which upholds the highest bioethics and commitment to quality animal care.

Preclinical Toxicology Services

Are you looking for safety data to support your IND or clinical submission? The Drug Safety Testing Center (DSC) specialises in GLP-compliant rodent toxicology studies, delivering high-quality safety data with the quality, consistency, and reproducibility that regulators require. For studies requiring non-rodent species, DSC can coordinate with qualified partner facilities to support your programme end-to-end.

Non-GLP Contract Research Services

Beyond GLP-compliant pivotal studies, DSC provides flexible non-GLP contract research to support early decision-making and IND-enabling programmes. Non-GLP studies at DSC are ideal for exploratory toxicology, dose selection, and proof-of-concept work, with faster turnaround and lower cost than full GLP studies.

Services include:

• Exploratory and pilot toxicology (single- and repeat-dose)
• Pharmacokinetics (PK) and pharmacodynamics (PD)
• Dose range-finding and dose selection
• Proof-of-concept efficacy studies
• Bioanalytical method development and validation
• Exploratory histopathology

Preclinical Research Facility Rental

DSC offers rental of AAALAC-accredited, turnkey in vivo research facilities on flexible terms. Biotech companies, universities and CRO partners can conduct their own preclinical studies in DSC's barrier vivarium suites without building their own facility.

• AAALAC-accredited barrier suites with strictly controlled environments
• On-site professional husbandry, veterinary and technical support
• Shared procedural, imaging and laboratory facilities
• Flexible lease terms — short-term projects to long-term residency
• All studies conducted under rigorous IACUC oversight and the highest bioethical standards
• Located within Hong Kong Science Park's biotech ecosystem

Contact us to discuss your study requirements or arrange a facility tour.