OmniaBio
OmniaBio is a Canadian cell and gene therapy CDMO operating Canada's largest purpose-built CGT manufacturing facility in Hamilton, Ontario, providing AI- and robotics-enabled process development, GMP manufacturing, and commercial supply services to biotech, pharma, and academic clients across immunotherapy, lentiviral vector, and iPSC platforms.
- Company typePrivate
- Founded2022
- HeadquartersHamilton, Canada
- Headcount101–250
- GTM typeB2B
- OfferingServices
What OmniaBio does
OmniaBio is a privately held, Canada-based contract development and manufacturing organization (CDMO) focused on cell and gene therapies (CGT). Founded in 2022 as a commercial-stage subsidiary of CCRM (Centre for Commercialization of Regenerative Medicine), the company operates a 120,000 sq. ft. purpose-built manufacturing facility at McMaster Innovation Park in Hamilton, Ontario, which opened in October 2024 and is described as Canada's largest CGT CDMO. It serves pharmaceutical and biotechnology companies, as well as academic medical centers, that require process development, analytical development, GMP manufacturing, cell banking, regulatory guidance, and supply chain management for autologous and allogeneic cell therapies, lentiviral vectors (LVV), and induced pluripotent stem cell (iPSC)-based products. Korean biotech MEDIPOST Co., Ltd. is both a $145M strategic investor and the company's first commercial-stage customer (manufacturing CARTISTEM for North American patients).
The company's core technology stack is branded as the "Hamilton Intelligent Factory," which integrates AI models, robotics, and closed-unit processing systems across three technology platforms: Immunotherapy (CAR-T and NK cells), Lentiviral Vectors, and iPSC (with CRISPR-Cas9 gene editing and SOLUPORE non-viral transfection). Disclosed proprietary capabilities include machine-learning-based donor T-cell manufacturability prediction, automated QC reducing human involvement by 80%, 3-day rapid QC release, robotic "hotelling" of cell processing equipment (claimed to increase throughput per square meter by 300%), and AI-driven vein-to-vein logistics. Production capacity is stated at 1,200+ autologous batches annually, scalable to 5,000 doses by Q2 2026 and up to 30,000 doses with existing infrastructure.
OmniaBio generates revenue through phase-appropriate, milestone-based CDMO contracts covering preclinical through commercial manufacturing, with project-based pricing tailored to therapy type, development stage, and manufacturing requirements. Distribution is exclusively via direct enterprise sales to pharma, biotech, and academic clients, supported by dedicated project managers and near real-time data sharing. The facility is GMP-compliant with U.S. FDA, Health Canada, and European regulations, and received a Health Canada Drug Establishment License (DEL) in December 2025, enabling commercial manufacturing and distribution. Operations are supported by substantial non-dilutive funding, including combined government grants of approximately CAD $90.5M (Ontario $40M, Federal $40M, NGen $10.5M) alongside MEDIPOST's USD $145M corporate investment, into a broader ~CAD $580M facility program.
OmniaBio firmographics
Firmographics- Name
- OmniaBio
- Legal name
- OmniaBio Inc.
- Website
- https://omniabio.com
- Company type
- Private
- Founded year
- 2022
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- OmniaBio is a Canadian cell and gene therapy CDMO operating Canada's largest purpose-built CGT manufacturing facility in Hamilton, Ontario, providing AI- and robotics-enabled process development, GMP manufacturing, and commercial supply services to biotech, pharma, and academic clients across immunotherapy, lentiviral vector, and iPSC platforms.
- Ownership category
- akta.pro rank
OmniaBio industry classification
Industry- Product category
- Cell & Gene Therapy CDMO Services
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical and Medicine Manufacturing (32541)
- SIC
- Services-Commercial Physical & Biological Research (8731), Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Cell Therapy CDMO (HLAGABAD)
- akta.pro secondary industries
- Gene Therapy (Viral Vector/Plasmid) CDMO (HLAGABAE), Biologics (mAbs/Recombinant Proteins) CDMO (HLAGABAC)
Keywords
Where OmniaBio is headquartered
LocationHeadquarters
- HQ city
- Hamilton
- HQ country
- Canada
- HQ region
- North America
Offices4 records
Markets served
OmniaBio business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales
Revenue model
- CDMO Manufacturing Services: Contract development and manufacturing organization providing cell and gene therapy manufacturing services to biotech and pharmaceutical companies. Revenue generated through project-based contracts for process development, analytical development, GMP manufacturing, and commercial manufacturing services.
- Phase-Appropriate Services: Services span from preclinical development through commercial manufacturing, including process development, analytical development, cell banking, regulatory guidance, and supply chain management. Revenue model based on milestone-based project delivery.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels6 records
OmniaBio product offering
Product offeringCore offering
OmniaBio is a contract development and manufacturing organization (CDMO) providing end-to-end cell and gene therapy services from preclinical process development through commercial-scale GMP manufacturing. Its offerings are organized around three technology platforms (Immunotherapy, Lentiviral Vectors, and iPSC) and include process development, analytical development, cell banking, autologous and allogeneic manufacturing, regulatory guidance, and end-to-end supply chain security. Manufacturing is delivered from a 120,000 sq. ft. AI- and robotics-enabled Hamilton facility, supported by a Toronto preclinical and clinical site.
Product overview
OmniaBio is a technology-focused Cell & Gene Therapy CDMO offering a unified platform of manufacturing services built around three core technology platforms: Immunotherapy (CAR-T, NK cells), Lentiviral Vectors (LVV), and iPSC (induced pluripotent stem cells). The integrated service portfolio spans preclinical to commercial manufacturing, comprising Process Development, Analytical Development, GMP Manufacturing, Commercial Manufacturing, Autologous Cell Therapy Manufacturing, Cell Banking, Regulatory Guidance, and Supply Chain Security. The Hamilton Intelligent Factory leverages AI and robotics as a differentiator, aiming to reduce production costs by 50-55% while quadrupling output. Services are offered through two facilities: a Toronto preclinical/clinical site (CCRM partnership) and the Hamilton commercial-scale facility.
Differentiator
Problem solved
Functional benefit
Products and services
- Cell & Gene Therapy CDMO Services End-to-end contract development and manufacturing services for cell and gene therapies, covering the full product lifecycle from preclinical development through commercial manufacturing. Includes process development, analytical development, GMP manufacturing, and regulatory guidance for biotech and pharmaceutical customers.
- Process Development Services Phase-appropriate process development and optimization for cell therapies, including scalable manufacturing platform selection, closed-system automation, and technology transfer. Integrates AI models and robotics for enhanced productivity, designed for biotech and pharma developers.
- Analytical Development Services Analytical capabilities for cell therapies including identity, purity, potency, cell count, and viability assays, plus custom assay development, flow cytometry, qPCR/ddPCR, and ELISA-based testing for cell and gene therapy developers.
- Commercial Cell Therapy Manufacturing Commercial-scale cell therapy manufacturing at the Hamilton facility with capacity for up to 5,000 doses annually (scalable to 30,000). Features GMP-certified cleanrooms, in-house QC labs, and 24/7 manufacturing schedules for biotech and pharma customers.
- Autologous Cell Therapy Manufacturing AI- and robotics-enabled autologous CAR-T manufacturing at the Hamilton Intelligent Factory, integrating closed-unit systems with machine learning for enhanced production rates and reduced per-batch costs. For CAR-T cell therapy developers.
- GMP Cell Therapy Manufacturing Good Manufacturing Practice (GMP)-compliant manufacturing services for lentiviral vectors, genetically modified cells, and iPSC-based therapeutics, ranging from preclinical development through commercial-stage GMP manufacturing in Grade B and C cleanrooms.
- Cell Banking Services Fully integrated cell banking services including Research Cell Banks (RCB), Master Cell Banks (MCB), and Working Cell Banks (WCB) for iPSC, immune cells, and other therapeutic cell types, with over 80 successful cell banks generated using standardized GMP workflows.
- Regulatory Guidance Cell therapy regulatory affairs consultation including regulatory plan development, CMC section drafting, FDA and Health Canada submission support, and regulatory interaction guidance for cell and gene therapy developers.
- Supply Chain Security End-to-end supply chain management for cell therapies including temperature-controlled logistics, cross-border transportation, real-time tracking, and 24/7 operations with a U.S. logistics hub in Detroit, Michigan.
- Immunotherapy Manufacturing Platform Cell therapy platform specializing in CAR-T and NK cell manufacturing with automated, closed, integrated process development. Offers both autologous and allogeneic engineered cell therapy capabilities for cancer and other disease developers.
- Lentiviral Vector (LVV) Manufacturing Platform End-to-end lentiviral vector production including upstream and downstream process development. Features serum-free suspension culture, scalable filtration, and optimized purification achieving up to 70% recovery at 1L scale.
- iPSC Manufacturing Platform GMP-compliant induced pluripotent stem cell reprogramming, gene editing (including CRISPR-Cas9), and differentiation services. Over 200 iPSC lines generated and characterized, with optimized screening for single-cell clone identification.
Quantifiable outcome
- 50-55% production cost reduction and 4X output increase in existing facility
- +6 more outcomes
Companies that use OmniaBio
Customer profileNamed customers3 records
Segments2 records
Ideal customer profiles2 records
OmniaBio technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration7 records
AI capability4 records
Feature9 records
OmniaBio partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered core, key, supporting and flagship.
- AvectascoreCCRM and OmniaBio announced agreement with Avectas to evaluate its automated, integrated and scalable cell therapy manufacturing platform. The evaluation focuses on improving automation, scalability and manufacturing efficiency to address key challenges that limit patient access to cell and gene therapies. The partnership coincides with plans to establish CCRM Ireland.
- BrainChild BiokeyCollaboration to accelerate CAR-T cell therapy development for brain cancer. OmniaBio provides next-generation CDMO services including robotics and artificial intelligence-enabled manufacturing to support BrainChild Bio's innovative cell therapy program.
- LineaBiosupportingLineaBio submitted a Drug Master File (DMF) for its Linea 1 GMP iPSC line to the FDA with OmniaBio support. OmniaBio provides GMP manufacturing and support services.
- Somite TherapeuticskeyPartnership to advance SMT-M01 for Duchenne muscular dystrophy (DMD). OmniaBio supports from process optimization, master cell banking, and iPSC differentiation to fill-finish to ensure drug product quality and clinical readiness.
- MEDIPOSTflagshipMEDIPOST is the first commercial-stage customer at OmniaBio's Hamilton facility, planning to manufacture CARTISTEM for North American patients. MEDIPOST is also an investor/partner in OmniaBio alongside CCRM. CARTISTEM is an allogeneic umbilical cord blood-derived mesenchymal stem cell product for knee osteoarthritis.
- Catamaran BiosupportingPartnership to advance allogeneic CAR-NK cell therapies for cancer treatment. Leverages OmniaBio's manufacturing capabilities for allogeneic cell therapy development.
Scale indicators12 records
Recent moves8 records
Expansion highlights4 records
OmniaBio competitors and assessment
Company assessmentBroad incumbents
- Charles River Laboratories: Charles River is a large contract research and manufacturing organization with cell and gene therapy services including manufacturing, viral vectors, and testing. It is comparable to OmniaBio as a CGT CDMO and CRO serving biotech and pharma clients, with broader portfolio spanning research models and biologics.
- Catalent (now part of Novo Holdings): Catalent is a major global CDMO with significant cell therapy manufacturing capabilities acquired through its Paragon Bioservices deal. It is comparable to OmniaBio as a CGT CDMO serving both clinical and commercial-stage programs, with broader service offerings across biologics and gene therapy.
- Thermo Fisher Scientific (Patheon): Thermo Fisher's Patheon CDMO business and its viral vector services division serve cell and gene therapy developers globally. It is comparable to OmniaBio as a large-scale, full-service CDMO with overlapping CGT capabilities, though it is far larger and serves a broader therapeutic range.
- Lonza Cell & Gene Technologies: Lonza is the world's largest cell and gene therapy CDMO with a global network of manufacturing facilities. It is comparable to OmniaBio as a full-service CGT CDMO offering autologous and allogeneic cell therapy, viral vector, and process development services, but at significantly larger scale and with an established commercial customer base.
Emerging players
- Cellares: Cellares is an emerging cell therapy manufacturing technology company developing the Cell Shuttle, an automated and scalable cell therapy manufacturing platform. It is comparable to OmniaBio's Hamilton Intelligent Factory concept, as both target cost reduction and throughput gains in autologous cell therapy manufacturing through automation.
- Andelyn Biosciences: Andelyn Biosciences is a US-based cell and gene therapy CDMO specializing in viral vectors and plasmid DNA manufacturing. It is comparable to OmniaBio as a focused CGT CDMO with overlapping capabilities in viral vector manufacturing and serving similar biotech client profiles.
Direct peers
- AGC Biologics: AGC Biologics is a global CDMO with cell and gene therapy manufacturing capabilities including viral vectors and cell therapy services. It is directly comparable to OmniaBio as a mid-to-large CDMO serving CGT developers from clinical to commercial stages, with overlapping capabilities in LVV and cell-based therapies.
- RoslinCT: RoslinCT is a Scotland-based cell and gene therapy CDMO specializing in iPSC and cell therapy manufacturing. It is directly comparable to OmniaBio as a specialized CGT CDMO with iPSC platform capabilities and a similar focus on process development and GMP manufacturing for advanced therapies.
- Minaris Regenerative Medicine: Minaris is a cell and gene therapy CDMO offering process development, GMP manufacturing, and commercial services for cell therapies and viral vectors. It is directly comparable to OmniaBio as a specialized CGT CDMO with overlapping service lines including autologous and allogeneic cell therapy manufacturing.
Regional players
- Cell and Gene Therapy Catapult: Cell and Gene Therapy Catapult is a UK-based innovation and manufacturing center supporting cell and gene therapy development with GMP manufacturing facilities. It is comparable to OmniaBio as a publicly-supported advanced therapy manufacturing organization, though it is regionally focused on the UK rather than North America.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
OmniaBio social profiles
Digital presenceOmniaBio compliance and trust
Trust signalCompliance2 records
OmniaBio financial estimates
Financial estimateRevenue estimate
Valuation estimate
OmniaBio leadership team
Management profileNumber of profiles
Profiles7 records
OmniaBio funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
OmniaBio M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about OmniaBio
What does OmniaBio do?
OmniaBio is a contract development and manufacturing organization (CDMO) providing end-to-end cell and gene therapy services from preclinical process development through commercial-scale GMP manufacturing. Its offerings are organized around three technology platforms (Immunotherapy, Lentiviral Vectors, and iPSC) and include process development, analytical development, cell banking, autologous and allogeneic manufacturing, regulatory guidance, and end-to-end supply chain security. Manufacturing is delivered from a 120,000 sq. ft. AI- and robotics-enabled Hamilton facility, supported by a Toronto preclinical and clinical site.
Is OmniaBio a public or private company?
OmniaBio is a private company. It is classified as corporate owned and is currently operating.
When was OmniaBio founded?
OmniaBio was founded in 2022. It employs 101 to 250 people.
Where is OmniaBio based?
OmniaBio is headquartered in Hamilton, Canada, in the North America region.
How does OmniaBio make money?
Two revenue lines are on record. CDMO Manufacturing Services are the primary driver. The others are phase-Appropriate Services.
Who are OmniaBio's main competitors?
Broad incumbents on record are Charles River Laboratories, Catalent (now part of Novo Holdings), Thermo Fisher Scientific (Patheon) and Lonza Cell & Gene Technologies. Emerging players are Cellares and Andelyn Biosciences. Direct peers are AGC Biologics, RoslinCT and Minaris Regenerative Medicine. Cell and Gene Therapy Catapult is listed as a regional player.
Does OmniaBio have an API?
No public API is recorded for OmniaBio.
What industry is OmniaBio in?
OmniaBio's product category is Cell & Gene Therapy CDMO Services. Its primary akta.pro industry code is HLAGABAD, Cell Therapy CDMO, with a secondary code of HLAGABAE, Gene Therapy (Viral Vector/Plasmid) CDMO. Its NAICS code is 325414 and its SIC code is 8731.