News

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, […]

The C3i Center is proud to announce the appointment of Bobby Boursiquot, B.Sc., MBA, as Vice President of Commercialization. With over two decades of experience in scientific innovation and commercial growth, Mr. Boursiquot will lead the C3i Center’s initiatives to accelerate the transfer of cell and gene therapy discoveries to the marketplace. “Bobby’s rare combination […]

What Do DEL and EMA Licenses Mean for Our Day-to-Day Operations? Our commercial manufacturing licenses allow us to manufacture and test cell therapy products for the commercial market. To achieve it, all our processes were reviewed and adjusted to meet the highest regulatory standards. The level of qualification/validation of manufacturing processes, equipment, facilities, analytical methods, […]