Mitch Sivilotti, CEO of OmniaBio Inc., shared with CanadianSME Small Business Magazine how OmniaBio is propelling Canada to the forefront of cell and gene therapy (CGT) manufacturing. As Canada’s largest contract development and manufacturing organization (CDMO) for CGTs, OmniaBio specializes in creating biologic therapies aimed at treating severe diseases, representing hope for countless patients globally. With a focus on pre-clinical to Phase II services and plans for significant facility expansions, OmniaBio is setting the stage for preclinical to commercial manufacturing of gene-modified cell therapies and viral vectors, catering to therapy developers across various regions. Mitch highlights OmniaBio’s commitment to advancing manufacturing technology, particularly in iPSCs, gene editing, cell and immunotherapies, and vector technologies, while also emphasizing the importance of workforce development in collaboration with the Canadian Advanced Therapies Training Institute (CATTI) to ensure a pool of skilled GMP workers. This holistic approach underpins OmniaBio’s pivotal role in enhancing Canada’s capacity, capability, and expertise in the CGT space, ultimately contributing to making these advanced therapies more accessible to patients. Mitch distinguishes OmniaBio from other CDMOs through its focus, technology, relationship with CCRM, and unique collaborative culture, positioning it as a leader in bringing CGTs to patients worldwide. Looking ahead, OmniaBio aims to continue innovating in technology and partnerships to optimize manufacturing, quality control, and logistics, thereby advancing the CGT manufacturing landscape.
Mitch Sivilotti is a respected leader in the Life Sciences industry and serves as the Chief Executive Officer of OmniaBio Inc.
Most recently, Mitch was the Chief Operating Officer at CCRM, a Toronto-based cell and gene therapy (CGT) accelerator focused on viral vector and cell therapy manufacturing innovation, company creation and early-stage venture investments. Over the course of five years at CCRM, Mitch was responsible for creating a contract development and manufacturing organization with 200 employees, which has grown to become OmniaBio Inc. Before joining CCRM, Mitch was the President of TotipotentRX Corporation, which designed and commercialized sterile disposables for the CGT market, and developed a therapeutic pipeline of candidates for cardiovascular diseases. Its lead product was granted pivotal trial approval in the U.S for Critical Limb Ischemia. TotipotentRX, co-founded by Mitch in 2007, was acquired by Thermogenesis Corporation (Nasdaq: THMO) in 2014. Mitch’s professional career began at Pall Corporation, a Danaher company (NYSE: DHR), where he held several business management and technical positions focused on process equipment and sterile consumables for the advanced therapies market.
Mr. Sivilotti 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, where he has supported an ex-officio member seat for CCRM for four years.
Mr. Sivilotti holds a graduate degree in Cellular and Molecular Biology from the Université Laval (Quebec, Canada) and a graduate degree in Finance from Queen’s University (Kingston, Canada).
Can you elaborate on how OmniaBio contributes to establishing Canada as a leader in cell and gene therapy manufacturing?
OmniaBio Inc. will be Canada’s largest contract development and manufacturing organization (CDMO) focused on cell and gene therapies (CGTs). We manufacture biologic therapies that seek to treat or provide curative options for intractable diseases – a source of hope for many patients worldwide. We currently provide pre-clinical through Phase II services (process and analytical development and Good Manufacturing Practices (GMP) supply) from our Toronto site in collaboration with the Centre for Commercialization of Regenerative Medicine (CCRM) and are nearing completion of our second facility (commercial supply) in summer 2024 (120,000 sq ft) in Hamilton, Ontario. Based on market demand, we also have plans for a third facility, which we expect to come online in 2027. As of this summer, 2024, OmniaBio will offer preclinical to commercial manufacturing of gene-modified cell therapies and viral vectors for therapy developers in Canada, the U.S., Europe and Asia.
OmniaBio is a subsidiary of CCRM, a leader in developing and commercializing regenerative medicine-based technologies and CGTs. CCRM wants to make Canada a leader in cell and gene manufacturing, and OmniaBio is pivotal to the realization of that goal. In terms of manufacturing technology advancement, together with CCRM and innovative partners like Cytiva, OmniaBio is making a significant contribution to CGT manufacturing technology in our core areas of expertise: induced pluripotent stem cells (iPSCs) and gene editing, cell and immunotherapies, and vector technologies (Lentivirus, or LVV, and non-viral technologies). In addition to our investment in these biologic areas, we are developing capabilities that optimize and automate production, quality control and logistics as key areas for cost optimization, all leveraging data (AI/machine learning) to drive the best possible outcomes for our clients and their patients.
In terms of workforce development, we have created a partnership with the Canadian Advanced Therapies Training Institute (CATTI), and together we are building a comprehensive and unique training system to upskill and maintain our highly skilled GMP workforce – GMP are the guidelines and standards, enforceable by law, which govern our industry – so our products are compliant with the U.S. Food and Drug Administration (FDA), Health Canada and European Medicines Agency. The training we provide, in collaboration with CATTI, will produce a large pool of GMP workers, who will not only benefit OmniaBio but, in the future, support the growth of an ecosystem of CGT-trained and experienced personnel.
So, in combination, OmniaBio is making a major contribution to Canada in terms of capacity, capability (manufacturing technology and cost reduction/efficiency through automation) and workforce development.
Why is OmniaBio’s work crucial for making cell and gene therapies more accessible to Canadian patients?
I believe this is an ecosystem question as OmniaBio, as part of the CCRM family, is building the foundation for an advanced biomanufacturing ecosystem in Canada, supplying both domestic and international partners with unique, life-saving therapies. We will do this through capacity, technology, efficiencies and workforce development. One can easily imagine how these contributions will directly, through the provision of services, or indirectly, through the expertise of a growing CGT workforce, support the creation, growth and ultimately play a role in the success of new companies and technologies that may have previously struggled to grow in Canada.
In a field with several key players, what distinguishes OmniaBio from other contract development and manufacturing organizations (CDMOs) in the cell and gene therapy space?
There are many differentiators and I’m happy to list a few:
- Focus and technology: We are specialists in cell and vector development and GMP manufacturing in contrast to other organizations that provide services across a broader portfolio of technologies. This focus allows us to think deeply about our capabilities and invest in the key technologies that matter most to our clients and the success of their programs. This also goes well beyond biologics technology as we partner to advance efficiences through automation. Working with a focused CDMO makes a world of difference.
- CCRM: We are a science-first organization that has almost 13 years of experience in CGTs in combination with CCRM. We are part of a unique ecosystem that thinks differently by supporting companies from inception through to commercial supply, and this has been demonstrated by our contributions to the industry, which include advocacy, guideline development and supporting organizations like CATTI, which will ultimately serve the market with CGT-specific GMP training.
- Culture: OmniaBio has a unique collaborative culture. We have built a trusted and flexible team of highly skilled scientists, and veteran operations and quality teams. After just one visit to one of our facilities, all of our collaborators and clients clearly understand the culture and foundation it provides for successful project execution.
With the completion of OmniaBio’s first commercial facility and plans for more, how do these expansions align with your vision for the company’s future and its impact on the industry?
Our vision is to be a leader in bringing CGTs to patients around the world. Our first commercial facility will round out our plan to provide services from preclinical process and analytical development through to commercial supply in our key manufacturing platforms (iPSCs, cell therapy/immunology and LVVs). Once completed, additional expansions will be based in new geographies and built on a combination of key knowledge partnerships and efficient manufacturing and distribution principles. Our new facilities will continue to leverage the latest learnings in how to manufacture and supply these complex medicines as efficiently as possible. When we refer to innovation alongside our expansion plans, we are referring to both the biology supporting our manufacturing platforms and also the automation and data that will drive further efficiencies in the future. Building new facilities is a great advantage vs. organizations that are leveraging older infrastructure.
Looking forward, what are the next big steps or innovations OmniaBio aims to achieve in the cell and gene therapy manufacturing landscape?
We will continue to lead through development of new technologies and partnerships, both in Canada and in regions that make sense to our clients, particularly in pursuit of lowering the cost of goods in manufacturing, quality control and logistics through more efficient, reliable, high quality and rapid production of these life-saving therapies. This will include investing in capabilities for our existing areas of expertise and new modalities, while our interest in leveraging advances in automation and data-based decision-making (AI) will most certainly influence our plans.
