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AI-enabled biomanufacturing innovation enhances affordability and access to cell and gene therapies

  

Rebecca Ihilchik, MA
Stacey Johnson, MSc
CCRM

The discourse around artificial intelligence (AI) is seemingly everywhere nowadays. Increasingly influential in our everyday lives, AI has transformed multiple industries and is only gaining speed. This may lead professionals in the cell and gene therapy (CGT) sector to wonder how AI will impact CGT manufacturing. How can we harness the power of AI to address the big-picture questions of our industry?

With the recent opening of its new AI centre of excellence, OmniaBio Inc. is forging ahead in its quest to employ AI to increase affordability and access for patients around the world in desperate need of lifesaving CGTs.

“OmniaBio was established with a singular focus on cell and gene therapies,” explains Mitchel Sivilotti, President and CEO, OmniaBio Inc. “It’s a CDMO [contract development and manufacturing organization] that is technology-focused and leverages the latest learnings on how to manufacture and supply these complex medicines as efficiently as possible, using automation and data.”

As a subsidiary of Toronto-based CCRM, a leader in developing and commercializing regenerative medicine-based technologies and CGTs, OmniaBio offers comprehensive and tailored CDMO services, cutting-edge development and reliable Good Manufacturing Practices (GMP) capabilities. With capacity and capabilities from preclinical to commercial-stage manufacturing, OmniaBio specializes in immune cell-based therapies, induced pluripotent stem cell therapies and lentiviral vectors, driving advancements in the field and bringing maturity to cell and gene therapy.

In October 2024, OmniaBio opened its new commercial-ready manufacturing facility and AI centre of excellence in Hamilton, Ontario, Canada. At 100,000 sq. ft., the new state-of-the-art facility is now Canada’s largest CDMO dedicated to CGTs. The facility is a groundbreaking development for both the Canadian biotech industry and the broader global market. It is also OmniaBio’s stage for ramping up its pioneering AI-enabled preclinical process and analytical development, and GMP manufacturing.

Left: OmniaBio's new commercial-ready manufacturing facility
Right: Ribbon-cutting ceremony celebrating the facility's launch

“OmniaBio is a crucial part of CCRM’s manufacturing strategy as it delivers the commercial-scale manufacturing we wanted to make available to cell and gene therapy developers and pharma companies,” says Michael May, President and CEO, CCRM. “OmniaBio builds on years of fine-tuning our knowledge and expertise in cell reprogramming and engineering, viral vectors, process development and GMP. To be able to offer these capabilities to companies in Canada and around the world is very gratifying.”

AI applications in CGT manufacturing

As more CGTs are approved by regulatory agencies across the globe, the need to decrease costs and increase high-quality output in manufacturing is more intense than ever. Recognizing this rising need, OmniaBio is among the first CGT CDMOs globally working to integrate advanced AI technologies to enhance process optimization, reduce costs, improve product quality, and increase production rates compared to conventional CDMO approaches.

Though there are many potential applications of AI, OmniaBio is currently focusing on the following:

1.      Robotics. This term encompasses a range of complexity, from robotic arms to full humanoid robots. With the appropriate quantity and variety, robots can execute many manufacturing tasks currently performed by people. Deeply integrating robotics in CGT manufacturing could mean taking up to 80 per cent of the current human power out of the lab, with robots executing the same steps with a smaller footprint and reducing the chance of human error. Robotics can also collect data on the work as it is happening, resulting in a more fulsome database to base future AI algorithms.

2.      Biosensors. Biosensors play a key role in ensuring biomanufacturing standardization and quality control. Vision-based control systems can be used to examine robotic actions taken in cell therapy production and ensure steps are being executed correctly, with the goal of AI to detect whether or not the cell therapy has been perfectly executed.

3.      Machine learning. Machine learning, already employed across many industries, allows computers to learn from data and generate decisions or predictions. In CGT manufacturing, it can gather data throughout the production and development cycle and use it to provide useful insight. For example, machine learning may provide suggestions about materials used in the manufacturing process that could be substituted to produce a better or less expensive product.

OmniaBio: bringing maturity to cell and gene therapy

OmniaBio’s long-term goal is to use the efficiencies afforded by robotics, biosensors, machine learning, and other forms of AI to decrease 50 per cent of the manufacturing cost for customers, and ultimately for patients. OmniaBio’s AI-enabled manufacturing will first focus on cellular immunotherapies and iPSC-based therapies.

The road to a fully integrated AI-enabled manufacturing operation is long and complex, requiring an extensive build-out of IT infrastructure; meeting compliance and regulatory standards; increased operating cost; and the training, re-training, and change management of the workforce. As an innovator in the field, OmniaBio is meeting the challenge head-on.

Connect with OmniaBio at cdmo@omniabio.com to learn more.


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