Good Manufacturing Practice (GMP) Facility
From left to right: Nahian Rahman, Olivia Caunday Ep Rigot, and Jagrutiben Chaudhari
The Columbia Institute for Cell Engineering and Therapy (CICET) Good Manufacturing Practice (GMP) Facility at the Vagelos School of Physicians and Surgeons and Columbia University Irving Medical Center is a state-of-the-art manufacturing center dedicated to advancing cell and gene therapies to the bedside. Purpose-built to support early-stage clinical studies, the facility features clean rooms for vector production and cell manufacturing, supported by robust systems for quality control, quality assurance, and regulatory compliance. As part of CICET’s core mission to promote and strengthen the research continuum across the biological, translational, manufacturing, and clinical dimensions of cell engineering and therapy, the facility provides a framework for bringing translational to provide safe, reliable products for patients.
The GMP Facility bridges the critical gap between basic science and medicine, facilitating the seamless translation of research-scale processes to clinical-grade GMP manufacturing that is suitable for clinical investigation. The facility supports the acceleration of new cell and gene therapies into first-in-human studies. CICET operates this dedicated GMP facility for Phase 1/2 clinical manufacturing, thereby positioning Columbia to advance today’s innovations and rapidly deliver tomorrow’s cell and gene therapy breakthroughs. By integrating scientific excellence and FDA standards, stringent quality assurance, and regulatory guidance for developing Chemistry, Manufacturing, and Controls (CMC) for Investigational New Drugs (IND) applications, the facility empowers Columbia's researchers, clinical teams, and partners to provide innovative treatments and enable access to emerging cell and gene therapies.
Process Development (PD) and GMP Manufacturing
CICET's Process Development and GMP Manufacturing team offers the expertise and infrastructure necessary to translate research-scale processes into cGMP-compliant production of clinical-grade cell and gene therapies. Collaborating closely with Columbia investigators, our team adapts and optimizes research production protocols for scalability and GMP manufacturing, ensuring that novel therapies are produced under current GMP and FDA standards and rigorous QA oversight. Our approach entails early collaboration with Columbia scientists to ensure the GMP translatability of research-scale protocols as well as seamless technology transfer for timely GMP production of vectors and cell-based products for Phase 1 and Phase 2 clinical trials. By merging scientific innovation with stringent quality control and assurance, and under expert regulatory guidance, CICET makes possible and accelerates the critical transition of cell and gene therapies from bench to first-in-human studies.
Quality & Compliance
CICET’s GMP Facility upholds the highest standards of safety, consistency, and regulatory compliance. These measures ensure every cell and gene therapy product is rigorously tested, documented, and manufactured to meet FDA requirements and deliver safe, reliable treatments to patients.
Quality Assurance
Leadership: Olivia Caunday Ep Rigot, PhD — Associate Director, Quality Assurance
Quality Assurance is a critical component of CICET, required by the current Good Manufacturing Practices (cGMP) guidelines enforced by the FDA. The production of cell and gene therapy products combines highly complex and sensitive operations that require a robust Quality Assurance system in place to safeguard product quality. The overarching goal is to ensure consistent manufacturing, regulatory compliance, and patient safety.
Process validation and ongoing monitoring of the environment demonstrate that each product manufactured is reliable and meets predefined specifications. Good documentation practices are applied to all CICET activities, including standard operating procedures, batch records, and data logs.
The QA director implements corrective and preventive actions and audits as needed. The incorporation of a risk management policy anticipates and mitigates failures upon process development decision-making.
Quality Control
Leadership: Jagrutiben Chaudhari — Associate Director, Quality Control and Analytics
The Quality Control (QC) and Analytical Development unit provides comprehensive product release testing and end-to-end analytical support to ensure the highest standards of safety, identity, purity, and potency for cell and gene therapy products. With advanced instrumentation, cutting-edge technologies, and cGMP-compliant expertise, our team delivers reliable, regulatory aligned solutions that accelerate programs from early development through clinical manufacturing.
Key Capabilities:
- In-Process and Lot Release Testing: Complete QC package including sterility, mycoplasma, endotoxin, cell viability, transduction efficiency (flow cytometry), vector copy number (qPCR/ddPCR), and residual impurity assessments.
- Analytical Method Development and Validation: Custom molecular and cellular assays tailored for viral vectors and cell therapies, aligned with regulatory expectations. Development and qualification of Cytotoxicity assays, Cytokine release assays, and Cytokine independent growth assay to assess functional activity, safety, and potency.
- Product Characterization and Stability Programs: Comprehensive stability studies for cellular products and selected viral vectors, including flow cytometry-based phenotypic profiling, viral vector titration, and molecular assays for long-term monitoring.
- Raw Material Testing: Rigorous qualification and testing programs for critical reagents and raw materials to ensure GMP facility compliance.
- Post-Infusion Monitoring: Longitudinal patient sample analysis using Flow cytometry and qPCR/ddPCR to quantify expansion and persistence of genetically modified cells in clinical trial subjects.
- Regulatory & Technical Support: Generation of high-quality data packages to support IND submissions and FDA responses.