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501 Smyth Box 511 Ottawa , ON, K1H 8L6 CanadaThe Ottawa Virus Manufacturing Facility (OVMF), supported by the Mulcahy Family is a Contract Manufacturing Organization located in the Ottawa Hospital Research Institute. The OVMF specializes in the production of Biosafety Level 2 (BSL-2) viruses for human clinical trials. Together, our highly qualified team has over 50 years of collective experience in Process Development and GMP manufacturing. We have successfully undergone GMP audits to FDA and European standards and have manufactured several oncolytic rhabdoviruses and poxviruses for clinical trials currently ongoing or completed in Canada, the United States and Europe. Our facility GMP facility. The OVMF has a validated Grade B GMP-compliant manufacturing facility specifically designed to manufacture BSL-2 pathogens. The facility has both gowning and de-gowning airlocks for proper personnel flow and validated cleaning procedures to maintain compliance with ISO 5 standards. The 37 m2 GMP facility houses a RollerCell 40 (RC40) incubator permitting the simultaneous production from 40 extended roller bottles with a combined cell growth surface area of 170,000 cm2. Process development and assay development suites. To facilitate the continuous improvement of our manufacturing process, we have a dedicated Process Development (PD) suite that contains all equipment necessary to undertake full-scale or scaled-down engineering runs. Complimentary to our GMP manufacturing core, our facility also houses a dedicated and access controlled QC/GLP testing lab. Here, we perform biochemical, potency, and identity assays that are qualified for release and characterization testing of process development samples, clinical drug products, and clinical samples. All assay development, SOP development, execution, and validation are in accordance with ICH Q2 guidelines as appropriate for early phase clinical trials, ensuring quality results for analytical procedures. Execution of all validated assays involves controlled, reference standard banks used in parallel with assay samples. All equipment is qualified for use (IQ/OQ or PQ) and calibrated. All critical equipment, including fridges, freezers, and incubators are monitored 24/7. Meeting client needs. We place a high value on the management of our academic and industry client projects, and the relationship with our clients. The OVMF has a team of dedicated project managers, and provides project management services to all of our clients as part of our offering. Project managers are responsible for ensuring all client project milestones are met, and lines of communication are clear, and streamlined. Competitive advantage: Over 50 years of collective experience manufacturing BSL-2 Poxviruses and Rhabdoviruses viruses for human clinical trials. In-house suite and staff dedicated to assay and process development. Manufacturing processes and facilities compliant with requirements of aseptic production. Onsite development and execution of validated SOPs for clinical sample processing.
501 Smyth Box 511 Ottawa , ON , K1H 8L6 CanadaThe Ottawa Virus Manufacturing Facility (OVMF), supported by the Mulcahy Family is a Contract Manufacturing Organization located in the Ottawa Hospital Research Institute. The OVMF specializes in the production of Biosafety Level 2 (BSL-2) viruses for human clinical trials. Together, our highly qualified team has over 50 years of collective experience in Process Development and GMP manufacturing. We have successfully undergone GMP audits to FDA and European standards and have manufactured several oncolytic rhabdoviruses and poxviruses for clinical trials currently ongoing or completed in Canada, the United States and Europe. Our facility GMP facility. The OVMF has a validated Grade B GMP-compliant manufacturing facility specifically designed to manufacture BSL-2 pathogens. The facility has both gowning and de-gowning airlocks for proper personnel flow and validated cleaning procedures to maintain compliance with ISO 5 standards. The 37 m2 GMP facility houses a RollerCell 40 (RC40) incubator permitting the simultaneous production from 40 extended roller bottles with a combined cell growth surface area of 170,000 cm2. Process development and assay development suites. To facilitate the continuous improvement of our manufacturing process, we have a dedicated Process Development (PD) suite that contains all equipment necessary to undertake full-scale or scaled-down engineering runs. Complimentary to our GMP manufacturing core, our facility also houses a dedicated and access controlled QC/GLP testing lab. Here, we perform biochemical, potency, and identity assays that are qualified for release and characterization testing of process development samples, clinical drug products, and clinical samples. All assay development, SOP development, execution, and validation are in accordance with ICH Q2 guidelines as appropriate for early phase clinical trials, ensuring quality results for analytical procedures. Execution of all validated assays involves controlled, reference standard banks used in parallel with assay samples. All equipment is qualified for use (IQ/OQ or PQ) and calibrated. All critical equipment, including fridges, freezers, and incubators are monitored 24/7. Meeting client needs. We place a high value on the management of our academic and industry client projects, and the relationship with our clients. The OVMF has a team of dedicated project managers, and provides project management services to all of our clients as part of our offering. Project managers are responsible for ensuring all client project milestones are met, and lines of communication are clear, and streamlined. Competitive advantage: Over 50 years of collective experience manufacturing BSL-2 Poxviruses and Rhabdoviruses viruses for human clinical trials. In-house suite and staff dedicated to assay and process development. Manufacturing processes and facilities compliant with requirements of aseptic production. Onsite development and execution of validated SOPs for clinical sample processing.
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