The PCDDP has qualified professionals and a state-of-the-art AAALAC accredited and OECD GLP compliant Vivarium, equipped with environmental control and data capturing systems, for conducting preclinical studies. The primary environmental and facility control is managed from an internal plant room, where the individual rooms can be isolated from the HVAC (heating ventilation and air conditioning) system. Lighting in the facility can be managed in terms of light intensity and photoperiod. All procedure rooms are fitted with infra-red lighting sources to facilitate after hour activities. When needed, night and day cycles can be reversed. A light dimmer system imitates the natural transition from day to night and vice versa. For studies with infectious agents such as bacteria and viruses, there is also a DALRRD certifiedBSL3 laboratory.

The PCDDP also has a breeding facility equipped to produce rodents — various mouse and rat strains under SPF conditions.  SPF status of the animals is confirmed by a health screening and sentinel program where the presence or absence of pathogens are determined according to a FELASA pathogen list. The facility has established procedures to ensure continued SPF status of the animals.

The facility and waste flows are designed to comply with cGMP requirements for vaccine batch release.  The PCDDP Vivarium has been validated according to a validation master plan and commissioned in accordance with GMP.  A quality management system is in place with procedures stipulated in controlled SOPs and all records are archived. 

The bioanalytical facility at the PCDDP specialises in the analysis of drugs and drug metabolites in various biological fluids and tissues.  The facility is equipped with a Sciex 4000 QTRAP tandem mass spectrometer linked to an Agilent 1290 UPLC and CTC-HTx PAL autosampler.  This instrument can provide shorter run times, high throughputs, HILIC and reverse phase chromatography, and superior sensitivity and selectivity through its Multiple Reaction Monitoring (MRM) mode.

Thus far, the facility has several validated methods for the analysis of commercial drugs in biological fluids including anti-diabetic drugs, blood pressure medication, anti-cancer drugs, antiretroviral medication, and cannabidiols.  The validation adheres to guidelines set out by the FDA and EMA, which involve a series of validation steps such as selectively, carry-over, linearity and sensitivity, precision and accuracy, matrix effects, dilution integrity and stability that must be within the range of specific statistical parameters. 

The PCDDP bioanalytical facility has a variety of sample preparation methods, to ensure optimal extraction of drug analytes from their sample matrix for accurate and reliable analysis.