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by

Laine Bodnar
Senior Manager Communications
CCRM

Whether you’ve visited Canada or not, you probably know that it’s famous for beautiful scenery, maple syrup and ice hockey. Canada is also where Drs. James Till and Ernest McCulloch defined the hallmark properties of stem cells in the early 1960s. Since that discovery 60 years ago, Canada has built and demonstrated scientific excellence in the field. 

Toronto-based CCRM, a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies, is collaborating with its network of academics, industry, investors and entrepreneurs, to build a thriving ecosystem in Canada with biomanufacturing a catalyst for that growth.  

OmniaBio Inc., a cell and gene therapy CDMO headquartered in Hamilton, Ontario, Canada

In the ever-expansive landscape of regenerative medicine, which now includes over 2,700 therapeutic developers worldwide, the journey from laboratory success to market-ready therapies demands expertise matched with a deep understanding of future trends. Success hinges on overcoming obstacles, and manufacturing is one of those challenges. 

OmniaBio, a subsidiary of CCRM, stands apart from other contract development and manufacturing organizations (CDMOs) with not only its capacity and expertise, but also with platform capabilities in immune-based cell therapies, lentiviral vectors (LVV), induced pluripotent stem cells (iPSCs) and companion gene-editing technologies. The seasoned team provides a holistic spectrum of services to seamlessly advance therapeutics from early process and analytical development to commercial-scale manufacture, reliably delivering transformative medicines to patients in need.

OmniaBio Inc. ground-breaking ceremony, October 2022

Navigating the evolving landscape with OmniaBio's expertise

At the core of OmniaBio's capabilities lies CCRM's deep technical knowledge and experience, setting the stage for success in the complex world of advanced therapies. CCRM was founded in 2011 and has been supporting the advancement of the global industry by overcoming challenges in manufacturing, talent development, attracting investment and launching new companies. 

OmniaBio was launched in 2022 to deliver an optimized CDMO experience and support a growing global advanced therapies industry. OmniaBio now takes the helm in supporting developers at all stages in their manufacturing journey. Whether navigating the intricacies of development bottlenecks, manufacturing clinical material or orchestrating commercial-scale manufacturing, OmniaBio provides a complete continuum of solutions, focusing on the success of the customer’s program. The availability to access the CCRM ecosystem is one of its great hallmarks, enabling solutions across the entire spectrum for a cell or gene therapy (CGT) product – from initial development in the lab to the final stages of large-scale production, to ultimately delivering transformative therapies to the market. 

Headquartered in Hamilton, less than an hour’s drive from Toronto, OmniaBio’s strategic location provides many advantages that its U.S. and international clients can leverage, such as easy access to Toronto’s biotechnology cluster that is comprised of world-leading research hospitals and the globally-ranked University of Toronto. The site is located a short distance from the U.S border and international air cargo airports. In addition, OmniaBio will open a Michigan-based logistics hub within minutes of the Detroit International Airport (DTW) with the largest number of direct flight routes to and from U.S. destinations and international hubs. 

This assures biologics-based medicinal products will reliably reach global destinations without delay

OmniaBio's immunotherapy solutions represent a new frontier of innovation in terms of process intensification and meaningful improvements in manufacturing economics for T- and NK-cell therapies. With closed, reproducible, and GMP-ready processes, its integrated team of process and analytical development experts and manufacturing, science and technology (MSAT) scientists, along with co-located development and manufacturing, allow for seamless technology transfers to GMP manufacturing. The team uses a modular approach that allows for technology-agnostic, custom solutions where advances in process and quality control automation can be leveraged. OmniaBio’s qualified assays for immunotherapies quantify potency, purity, cell number and viability, while it conducts custom assay development for viral vectors, immunotherapies and PSC-based products.

iPSCs: Tailored for quality and compliance

OmniaBio's iPSC development capabilities are meticulously designed to meet the highest standards of quality and compliance right from the start. It provides off-the-shelf GMP-compliant reprogramming platforms to produce therapeutic-grade iPSC lines, and uses a selectable menu of nucleases and delivery methods, including CRISPR-Cas9, to generate gene-edited iPSC lines with knock-in, knock-out, and single nucleotide polymorphism modifications. Using optimized screening approaches, OmniaBio ensures rapid and accurate identification of single-cell clones of interest. Its in-house analytics platform enables advanced cell line characterization, while its process scale-up capabilities facilitate the generation of various differentiated cell types at industry-leading bioreactor scales, ultimately providing a GMP-compliant clinical-scale production.

LVV production: Efficient, optimized, and scalably

In the domain of LVV production, OmniaBio excels in development of scalable and optimized GMP-compliant LVV production methods and provides platform and bespoke services. It offers serum-free HEK293 suspension transient, packaging and producer cell lines. Process development focuses on upstream and downstream optimization for efficient, high yield, and low residual scaled production. It offers single-use, and closed system processing at critical unit operations to enhance product safety. In-process testing, as well as a tailored approach to purification through a variety of chromatography resins and unique scalable filtration technology enable high percentage recovery while resulting in residual clearance at various scales. 

Building the facility to meet developers’ future needs

OmniaBio’s existing capacity is comprised of 40,000 square feet of process development and early-stage to Phase II GMP-compliant manufacturing across 10 clean rooms. OmniaBio’s new commercial manufacturing facility will anchor a biomanufacturing centre of excellence and will open with late clinical phase and commercial capacity in 2024 in a site totalling approximately 100,000 square feet. It will include expert process development, MSAT and Quality Control, and an additional 15 clean rooms. Looking forward to 2026, OmniaBio is planning a second commercial manufacturing site bringing another 300,000+ square feet online.

Embarking on a journey with OmniaBio

OmniaBio is committed to ensuring its clients’ ground-breaking innovations are optimized and scaled for manufacturing. Its mission is to prioritize client partnerships and CGT manufacturing innovation to improve the lives of patients around the world – a goal of CCRM’s for more than a decade. 

Contact OmniaBio to learn how the team is bringing maturity to CGT, and how its expertise and comprehensive solutions can usher your company’s product from concept to clinic. Reach out to the dedicated team at cdmo@omniabio.com.