Driving innovation in cell and gene therapy: the role of AI and robotics
Cell & Gene Therapy Insights 2025; 11(1), 59–67
DOI: 10.18609/cgti.2025.008
Jokūbas Leikauskas, Editor, Cell & Gene Therapy Insights, speaks with OmniaBio Inc.’s Kenneth Harris, Chief Strategy Officer and Head of AI, Mitchel Sivilotti, President and CEO, and Anthony Rotunno, Senior Vice President and General Manager/Site Head, about the innovative advancements in cell and gene therapy, focusing on how AI, automation, and robotics are revolutionizing manufacturing processes by reducing costs, increasing production capacity, and ultimately, improving patient outcomes in the rapidly evolving cell and gene therapy field.
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What makes cell and gene therapy (CGT) a pivotal advancement in the evolution of modern medicine, and how do you envision this field evolving in the coming years?
KH: A lot of us have all grown up taking pills and receiving injections for diseases. Unfortunately, traditional, one-size-fits-all medicines are not always effective for many rare diseases. There are over 7,000 rare diseases affecting humans, and it is often not appealing to pharmaceutical companies to target patient populations that might only consist of 10,000 or fewer people worldwide. CGTs can address this gap. It is often referred to as precision medicine–highly specialized treatments with individual doses tailored to the specific needs of each patient. While this approach can lead to higher costs, it is also far more efficacious and, in some cases, can even offer curative therapies, compared to the more generalized small-molecule pills and injections.
What is the main mission of OmniaBio?
MS: OmniaBio is a service organization specializing in the development and manufacturing CGT products. In essence, OmniaBio assists CGT developers with their processes from pre-clinical work and early-stage manufacturing to large-scale production, and helps establish their processes and analytical testing systems. Ultimately, the main mission is to manufacture CGT products for therapeutic developers from early-stage clinical trials up to commercial stages.
Our main mission is to be an exceptional partner to advanced therapy innovators, and we have multiple key areas of focus. One of them is being a technology leader, which involves acquiring the know-how and capabilities needed to provide services for manufacturing cutting-edge biologics. Another area of focus is collaboration between CGT developers and our technical teams to create new solutions that can be implemented into their manufacturing programs. Lastly, excellence in execution is crucial, and timely operations are part of OmniaBio’s DNA.
KH: OmniaBio’s mission is to manufacture life-saving therapies, particularly CGTs, focusing on rare diseases. The main goal is to reduce costs so that patients can access these therapies at an affordable price. As patient populations grow and the drugs become more effective, more people will become eligible for treatment. Consequently, the demand will increase, and we must maximize throughput in a single facility to meet that demand. OmniaBio’s current mission is to reduce the cost of therapies for rare diseases by 50% and quadruple the number of doses produced at the facility we have already built.
What sets OmniaBio apart in the field of CGT manufacturing?
MS: What differentiates OmniaBio is a strong emphasis on technology. We have been working in the CGT field for over 10 years. From the very early days to today, we have developed extensive experience, expertise, and know-how, which we share with manufacturers to help them bring their products to market. We achieve this by heavily investing in technology–both in scientific areas, such as biologics in the laboratory, and in technologies related to robotics and automation. These technologies are leveraged to make the products high-throughput, low-cost, and high-quality, and to ensure rapid turnaround to meet developers’ needs.
AR: OmniaBio stands out in North America primarily because of two key aspects. Firstly, all our employees have very strong backgrounds, and our operators undergo an extensive 4–6-week training course on aseptic technique handling, which is the key to our operations. The second differentiator is the focus on innovations such as AI, automation, and robotics—we are very quickly headed that way. The newly built facility is set up with all the knowledge that we have gained previously in our experience to easily integrate these technologies into the workflows.
KH: The core values of OmniaBio have always centered around innovation and rapid development, and AI aligns perfectly with these core values. Mitchel Sivilotti, our CEO, has been an entrepreneur throughout his career, and one of his goals for OmniaBio has always been to maintain that innovative edge. Additionally, as a Canadian organization, there is a strong focus on helping mankind. Therefore, OmniaBio’s values are not only about innovation but also about contributing to society and the well-being of people. Combining these elements creates a rare formula in this space.
How are you implementing AI and robotics to improve CGT manufacturing?
KH: Over the past 36 months, with the rapid development and advancement of AI, the pharmaceutical industry has been one of the first to adopt this technology. Finding drug targets and deciding whether they will be effective is not only a time-consuming process but also a very expensive one. For example, before testing a drug in humans, pharmaceutical companies can spend a decade in pre-clinical testing, investing billions of dollars before the drug is ever evaluated in human trials. AI can compress this decade-long process into months, providing a high probability of predicting whether a drug is a good candidate.
As AI and robotics continue to transform the CGT industry, one of the key challenges is that as these therapies get taken on by clinicians, the demand for doses will increase. However, building the infrastructure to produce even a small number of doses for the global market is a very long process. Therefore, OmniaBio plans to leverage the combination of AI and robotics to automate the production of advanced therapies.
Consequently, it can reduce manufacturing costs by 50–55% and quadruple our output in the same facility compared to what we had anticipated when the facility’s construction began three years ago. By implementing robotics, we are essentially removing humans from the risk profile. For example, one of the main benefits is a reduction in human error, less human movement, and fewer associated contaminants. Humans naturally shed microbes from our skin, hair, and breath, introducing potential contaminants into the environment, which can be significantly reduced with robots handling more tasks. Additionally, robots typically do not make mistakes and are consistent, which is much harder for humans to achieve.
What are the challenges and concerns regarding AI and how are you planning to address them?
KH: We often get asked about the security of AI, and I think it is important to separate fear from reality regarding how we apply this technology. There are a lot of concerns in the market about the safety of AI and the security of the data it uses. At OmniaBio, we have designed our system with robust security measures from day one. The software driving our AI-based platform is highly secured and stored in what could be described as a ‘vault,’ accessible only by a select number of OmniaBio employees. The customer data used by the AI is also protected and anonymized, ensuring it cannot be traced back to an individual.
For example, one would not know that a specific dataset belonged to ‘Ken.’ It is simply a set of anonymized data that is completely de-identified based on source and time. At OmniaBio, we use straightforward, simple mathematical models, and separate the AI used for manufacturing from generative AI models, such as ChatGPT, which we only use for informational purposes. These models help inform scientists and operators, but they are never involved in the day-to-day production of the drug. In our manufacturing processes, we rely on simpler AI models with mathematical algorithms to manage robots. These algorithms ensure the robots execute commands correctly, and if something goes wrong, the system will stop the process and notify a human operator to inspect the issue.
What excites you the most about the future of OmniaBio in the context of the rapidly evolving CGT industry?
AR: What excites me most about OmniaBio’s future is that we already have a purpose-built facility and a high-performing team. The patients who will receive our therapies are often extremely sick, and being able to deliver tens of thousands of doses to those in need of life-changing and life-saving therapeutics gives us a purpose. OmniaBio provides hope to patients who desperately need these treatments, and our strategic goals are focused on growing both locally and internationally.
KH: I am excited about the market OmniaBio is in. I think precision medicine is the future of healthcare, and the adoption of AI in this field is already a key focus in academic medicine today. OmniaBio is at the forefront of this shift, and I believe we will continue to lead in this area. We are a first-mover organization in this space, which not only gives us advantages but also opportunities to learn and adjust as we progress.
MS: What excites me most about OmniaBio’s future is our position in the biotech industry. We are providing cutting-edge solutions that directly benefit patients, and we get to witness the positive impact.
When we combine that with innovation and the new technologies our collaborators are developing, we are not just advancing biotechnology–we are also improving healthcare outcomes. Seeing these innovations make a real difference in patients’ lives is incredibly fulfilling.
Biographies
Kenneth Harris has expertise spanning 35 years in innovation and leadership in technology, medical devices, and therapeutics. Harris currently serves as the Chief Strategy Officer and Head of AI at OmniaBio Inc., Hamilton, Ontario, Canada. In this role, he leads the company’s corporate strategy and AI team, ensuring sustainable growth and cutting-edge implementation, safety, and scalability in healthcare robotics. Previously, Harris spearheaded the Academic Medicine and Public Health vertical within Amazon Web Services, developing the business from its inception leading a dynamic team comprised of principal trusted healthcare advisors, physician advisors, health informaticists, and healthcare IT architects. Prior to his tenure at Amazon, Harris notably founded and successfully took public a pioneering cell and gene therapy precision medicine company, marking a milestone in the advancement of cell therapy in cardiovascular medicine. Additionally, he played C-level and board roles with a Stanford University cell and gene therapy start-up, and led Pall Corporations global biomedical business for 13 years (now a Danaher company).
Mitchel Sivilotti is a respected leader in the life sciences industry and serves as the President and Chief Executive Officer of OmniaBio Inc., Hamilton, Ontario, Canada. Most recently, Sivilotti was the Chief Operating Officer at CCRM, a Toronto-based cell and gene therapy accelerator focused on cell therapy and viral vector manufacturing innovation, company creation and early-stage venture investments. Over his 6 years at CCRM, Sivilotti was responsible for creating a CDMO with 200 employees, which grew to become OmniaBio. Before joining CCRM, Sivilotti was the President of TotipotentRX Corporation, which designed and commercialized sterile disposables for the cell and gene therapy market, and developed a therapeutic pipeline of candidates for cardiovascular diseases. Sivilotti’s professional career began at Pall Corporation, a Danaher company, where he held several business management and technical positions focused on process equipment and sterile consumables for the advanced therapies market. He also sits on the board of the Standards Coordinating Body for Regenerative Medicine and is a regular contributor to the Forum on Regenerative Medicine at the National Academy of Sciences.
Anthony Rotunno is an executive leader with over 46 years of pharmaceutical manufacturing expertise that covers building facilities, optimizing operations, and supporting therapeutics developers from clinical to commercial scale. Rotunno currently serves as the Senior Vice President and General Manager/Site Head at OmniaBio Inc., Hamilton, Ontario, Canada. With deep experience in all facets of operations, revenue growth, and quality assurance, Rotunno has developed a strong track record in ensuring company and client success. While serving as Vice President of US manufacturing operations at Dendreon, MA, USA , Rotunno oversaw the construction and commissioning of two large-scale dedicated cell therapy manufacturing facilities. He guided the production of over 30,000 commercial lots, including Provenge, the first approved personalized immunotherapy for men with prostate cancer. With his knowledge in manufacturing and specific cell therapy experience firmly established, Rotunno founded Lykan Bioscience, where, as CEO, he built and led a therapeutic manufacturing facility and launched a CDMO focused on cell therapy manufacturing.
Affiliations
Kenneth Harris, Chief Strategy Officer and Head of AI, OmniaBio Inc., Hamilton, Ontario, Canada
Mitchel Sivilotti, President and CEO, OmniaBio Inc., Hamilton, Ontario, Canada
Anthony Rotunno, Senior Vice President and General Manager/Site Head, OmniaBio Inc., Hamilton, Ontario, Canada
Authorship & Conflict of Interest
Contributions: The named author takes responsibility for the integrity of the work as a whole, and has given his approval for this version to be published.
Acknowledgements: None.
Disclosure and potential conflicts of interest: The author has no conflicts of interest.
Funding declaration: The author received no financial support for the research, authorship and/or publication of this article.
Article & Copyright Information
Copyright: Published by Cell & Gene Therapy Insights under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.
Attribution: Copyright © 2025 OmniaBio Inc. Published by Cell & Gene Therapy Insights under Creative Commons License Deed CC BY NC ND 4.0.
Article source: This article is based on a podcast, which can be found here.
Podcast recorded: Apr 12, 2024;
Revised manuscript received: Dec 20, 2024;
Publication date: Jan 27, 2025.