Commercial Cell Therapy Manufacturing

CGT commercialization requires consistent quality in manufacturing while scaling up to meet patient demand at launch. Designed for efficient scalability, timely QC release, and reliable delivery, OmniaBio’s purpose-built facility enables our experts to offer you tailored solutions that support your commercial goals, even the most ambitious ones.

120,000 ft²

CGT Purpose-Built Facility

Grade B & C Cleanrooms

24/7

Manufacturing Schedule

120+ Years

Of Combined Leadership Experience in GMP

1,200+

Autologous Batches Annually (Varies based on process)

150+

Expert Staff

Your Experienced Commercial Partner

Scale your manufacturing throughput to meet total patient demand with OmniaBio’s commercial cell and gene therapy manufacturing site. Led by industry veteran Tony Rotunno, who previously oversaw 30,000+ commercial autologous cell therapy batches at a 98% success rate, our unmatched expertise provides reliable, efficient, and scalable solutions to meet your growing production needs.

Commercial-Readiness Support

Our team has experience supporting pivotal readiness activities, including process performance qualification (PPQ) control strategy, establishing and validating your manufacturing controls to deliver a Chemistry Manufacturing and Controls (CMC) section for your commercial filing, as well as providing batch monitoring and annual review of process data. Our good manufacturing practices (GMP) manufacturing facility is built to operate according to the Health Canada, FDA, and EMA standards and is designed to scale with you across all stages of clinical and commercial production. We collaborate closely with you along the way on commercial-readiness activities, ensuring that by the time you receive a regulatory notification of review, you are prepared to go through the pre-approval or pre-license approval regulatory inspection.

Phase III and Commercial-Ready Facility

Our high-throughput facility in Hamilton, Canada, is purpose-built to provide you with scalable, cost-effective manufacturing solutions tailored to your commercial cell therapy manufacturing needs.

At OmniaBio, we are integrating robotics, biosensors, and AI models in manufacturing to increase production rates, reduce costs, and enhance batch quality to make cell therapy treatments more affordable and accessible.

In-House Quality Control

Our 6,500 ft² dedicated QC lab enables in-house testing for direct quality control oversight, ensuring timely in-process and release testing results and the flexibility necessary to adhere to your program requirements. By offering internal QC testing, we can help you reduce costs and eliminate delays tied to third-party testing, accelerating the production and delivery of your cell therapy products.

Scalable Throughput to Meet Market Demands

OmniaBio’s state-of-the-art GMP facility in Hamilton, Ontario, is designed to scale with clients across all stages of clinical and commercial production:

Phase I: Low batch production to meet early-stage clinical needs.
Phase II/III: Currently capable of delivering up to 1,200 doses annually.
Commercial Scale: Automated manufacturing scaling up to 5,000 doses annually by Q2 2026.
Beyond 5,000 Doses: If you have larger demands, our facility includes infrastructure to expand capacity to 30,000 doses annually, ensuring you can meet the demands of larger patient populations.

Seamless Cross-Border Transportation

Our facility is strategically located near multiple airports, including Canada’s largest freight airport, and is less than 40 miles (64 kilometers) from the U.S. border, providing you with flexible and reliable transportation options across North America.

Experienced in navigating complex supply chains associated with personalized cell and gene therapies, our approach expedites reliable cross-border delivery of starting materials and final drug products in line with chains of custody and identity.

Same Day Services to Anywhere in North America*

Efficient and Secure Transporation with Flexible Scheduling

*Lower 48th U.S. states and southern Canadian provinces

210 Miles /

338 Kilometers
To DTW

40 Miles /

64 Kilometers
To YYZ

85 Miles /

137 Kilometers
To BUF

10 Miles /

16 Kilometers
To YHM

Inbound: Under 22 hours
Outbound: Under 18 hours

Same day services to anywhere in North America*

Efficient and secure transportation with flexible scheduling

*Lower 48th U.S. states and southern Canadian provinces

210 miles

To DTW

85 miles

To BUF

10 miles

To YHM

40 miles

To YYZ

Inbound: under 22 hours
Outbound: under 18 hours

Let’s Talk About Your Commercial Needs

Discover how OmniaBio can help you keep your program on track and meet your commercial cell therapy manufacturing needs.