News

From April 7 to 9, 2026, C3i took part in the 4th Pan-Canadian Strategic Forum on Cell and Gene Therapies, organized by CellCAN at the Sheraton Laval & Convention Center.   The event brought together key players in the sector, including scientists, innovators, and partners from the cell and gene therapy biomanufacturing ecosystem, around a […]

From March 29 to 31, 2026, C3i participated in the Summit for Cancer Immunotherapy (Summit4CI), organized by BioCanRx in Vancouver. This annual event brings together scientists, clinicians, industry leaders, and patient advocates committed to advancing immuno-oncology.   At the event, Jamie Sharp, Director of Business Development at C3i, represented the organization to engage with the […]

Regulatory inspections represent a critical validation of manufacturing quality systems in cell and gene therapy. These inspections assess not only whether procedures exist, but whether they are effectively implemented and consistently followed. For advanced therapy manufacturers, inspection readiness reflects the strength, maturity, and reliability of the entire Quality Assurance framework. At C3i, inspection readiness begins […]

Cell and gene therapy manufacturing presents distinct challenges compared to traditional pharmaceutical production. The use of living starting materials, open processing steps, and viral vectors introduces risks that cannot be mitigated solely by terminal sterilization. Among these, contamination control stands as one of the most critical and closely scrutinized aspects of manufacturing. Ensuring that products […]

Understanding the regulatory landscape for cell and gene therapy manufacturing is essential to ensuring compliance, product quality, and patient safety. Unlike traditional pharmaceuticals, these therapies rely on living starting materials, patient-specific processes, and advanced genetic technologies, introducing unique risks and variability. In this context, Quality Assurance plays a central role in ensuring that manufacturing systems […]

Our team was present at Advances Therapies Week in San Diego on February 9-12th, 2026.   Our takeaway is these six major key subjects the industry is clearly aligned on right now: Standardization & automation are the number 1 priority. Closed systems, modular processes, digital batch records. Variability that the field can control is no […]

In the complex world of cell and gene therapy, the reliability of every analytical result depends on one essential principle: validation. Within C3i’s GMP framework, each assay, instrument, and dataset must demonstrate that it is fit for purpose, capable of delivering accurate, traceable, and reproducible results that withstand regulatory scrutiny, ensuring Rigorous Validation in a […]

As cell and gene therapy technologies advance, molecular assays have become essential for ensuring both speed and safety in product release. At C3i, these assays are designed with a single objective: to deliver rapid, validated data that regulators and clinicians can trust. The mycoplasma assay exemplifies this balance. Traditional compendial methods require a 28-day culture […]

In cell and gene therapy, every hour matters. The ability to test, qualify, and release a product quickly can directly impact a patient’s access to treatment. At C3i, release testing is designed to deliver fast, reliable results without compromising scientific or regulatory rigour.   C3i’s Quality Control (QC) laboratory oversees every step of product testing, […]