Frequently Asked Questions ( FAQ)

Cell and gene therapy (CGT) manufacturing involves producing treatments that use living cells or genetic material to prevent, treat, or cure diseases.

Cell therapy: Uses modified or unmodified living cells (e.g., immune cells, stem cells) as the treatment itself.

Gene therapy: Delivers genetic material—often using viral vectors—to correct or replace defective genes within a patient’s cells.
Manufacturing these therapies requires highly controlled, sterile environments and customized processes since products are often personalized or biologically complex.

Good Manufacturing Practice (GMP) regulations ensure that products are consistently produced and controlled in accordance with quality standards. For CGTs, GMP requirements typically include:

• Validated and controlled processes to ensure product consistency and potency.

• Qualified facilities and equipment designed to maintain aseptic conditions.

• Trained personnel with specialized expertise in aseptic processing and biological systems.

• Comprehensive documentation and traceability for materials, reagents, and patient samples.

• Rigorous testing for identity, purity, sterility, and safety.

Because CGTs are often patient-specific, regulatory agencies (like the FDA, EMA, or Health Canada) may also require enhanced oversight of the chain-of-custody and chain-of-identity.

C3i is the leading CDMO in Canada for Cell & Gene Therapy manufacturing. There are distinct differences between each category of service providers: 

• CDMO (Contract Development and Manufacturing Organization): Provides both development and manufacturing services, helping clients design, optimize, and produce their therapies under GMP.

• CMO (Contract Manufacturing Organization): Focuses mainly on manufacturing products according to client specifications.

• CRO (Contract Research Organization): Supports research and clinical trials, such as preclinical studies, trial management, and data analysis.

• Biotech company: Develops its own therapeutic products and intellectual property, often outsourcing parts of development or manufacturing to CDMOs or CMOs.

GMP compliance ensures the safety, purity, and efficacy of biologically derived therapies. Non-compliance can result in:

• Contaminated or ineffective products posing risks to patients.

• Regulatory penalties, product recalls, or loss of market authorization.

• Damage to the company’s reputation and loss of trust from partners and regulators.

In CGT, where each batch may directly impact a patient’s outcome, adherence to GMP is essential for both patient safety and regulatory approval.

At C3i, we specialize in both types of cell therapies:

Autologous therapies: Use the patient’s own cells, which are collected, modified, and reintroduced.

• Advantage: No immune rejection risk.

• Challenge: Highly individualized and difficult to scale.

Allogeneic therapies: Use cells from a donor that can treat multiple patients.

• Advantage: Scalable “off-the-shelf” model.

• Challenge: Potential for immune rejection and need for immune suppression.

Yes! Currently, C3i can perform small-scale manufacturing of viral vectors. C3i is building a larger facility to support commercial GMP large-scale viral vector manufacturing, which is expected to open at the end of 2026.

Our specialist GLP and GMP labs offer a multitude of flow-cased and PCR-based assays. Please refer to our services webpage to see a complete lists of tests offered.

C3i is involved in several academic and industrial iPSC projects. We have iPSC world specialists on staff, ready to onboard new projects and support our current pipeline. 

Yes! C3i obtained a Drug Establishment License (DEL) in 2024 and, more recently, received a Commercial Manufacturing License from the EMA. 

Yes! C3i has a Technology Transfer Department which specializes in onboarding and scaling academic and industry projects to ensure GMP compliance. C3i is a CDMO, which means we provide both regulatory, Quality assurance, Manufacturing, and Quality control development. We have specialized teams dedicated to meeting the development needs of all of our clients. 

Cryopreservation in cell therapy is a freezing process used to preserve cells at very low temperatures in order to halt their metabolism and aging reversibly. The use of cryoprotective agents during cryopreservation helps maintain cell integrity and prevents damage caused by the formation of ice crystals. This process is essential for the storage and future use of cells, particularly in treatments such as stem cell transplants and CAR-T therapies.

Cold chain logistics and the transportation of cell therapy products are highly specialized process that requires strict control of temperature, transport conditions, and traceability. It involves the use of advanced technologies and validated equipment, including real-time monitoring systems such as smart sensors to track temperatures continuously. It also relies on specialized packaging solutions, such as cryogenic shipping systems at ultra-low temperatures, to ensure the integrity of cellular products.

A Master Cell Bank (MCB) is a well-defined and homogeneous population of cells derived from a single source (the same clone). It is prepared and stored under controlled conditions in compliance with GMP requirements. These cells are cryopreserved in multiple vials to ensure long-term stability and availability. The MCB serves as a unique, qualified reference for all future productions, ensuring that all cells used originate from the same source material. It is also tested to confirm the absence of contaminants and to verify genetic stability.

The storage duration of cell products or cell banks depends on the type of cells, the freezing process, and the storage conditions. Under GMP cryopreservation conditions (−150 °C or in liquid nitrogen), cells can be stored for several years without significant loss of viability or efficacy. Retrospective stability studies or periodic monitoring (including viability, identity, and contamination tests) are conducted to confirm product stability over time.