Mulcahy Family Manufacturing Facility

FACILITY EXPERTISE
On-site QA department, production manager, facility manager, QC technicians, process and assay development technicians, and 5 full-time GMP-trained staff with a combined 40 years of GMP manufacturing experience.

• Staff has produced clinical products for phase 1 and 2 clinical trials released in Canada, the US, and South Korea.
• Fully aseptic manipulation qualified and gown qualified for ISO 6/Grade B cleanroom.

Dedicated GxP assay facility able to perform several biochemical, potency, and identity assays

• Experienced staff in assay development, SOP writing, and assay validation for GMP release and characterization testing of biological products, for GLP toxicity study sample analysis, and for GCLP clinical sample analysis.
• Experienced staff in production process development, specifically with optimization of tangential flow filtration and other filtration steps, cell culture, virus infection, harvest, and purification.
   

COMPETITIVE ADVANTAGE

• The facility boasts a GMP-compliant and controlled material management system
• GMP, QA-released on-site VERO and HeLa Cell Banks
• There is a comprehensive environmental and personnel monitoring system coupled to a rigorous cleaning program, which includes vapourized hydrogen peroxide fumigation.  The cleaning program is qualified for consistency and validated for its ability to inactivate current products.
• The outer GMP area has several controlled and monitored -80°C, 4°C, -20°C, and liquid N2 freezers.
• All equipment is qualified, calibrated, and QC-monitored daily, weekly with chart recorders, and 24/7 with an electronic monitoring system that notifies staff upon technical excursions.