- On-site pharmacy facilities including temperature-controlled storage (-20ºC, 2–8ºC and 15-25ºC)
- Blinded and unblinded reconstitution, preparation and administration of investigational product including oral, topical, inhaled and intranasal routes plus subcutaneous, intra-articular and intramuscular injections, IV push (via cannula insertion) and stem cell delivery
- Participant education programs in self-administration and maintenance of cold chain storage of
- Investigational product and management of injection/administration reactions
On-site pathology sample preparation and storage including -20ºC and -70ºC temperature-controlled centrifuges and access to dry ice - Blinded and unblinded Erythrosite Sedimentation Rate (ESR)
- Assessments
Incubation for Quantiferon Gold - Assay Preparation
- Punch biopsy and tissue sample collection
- Sample collection for PK and PD markers including PBMC isolation, cytokine assessments, anti-PEG Ab, cytokine stimulation assays
- Geneotyping sample collection and processing
- IATA certified staff for sample shipping
- Access to NATA accredited pathology laboratories with expedited turnaround times
