The April 2026 issue of the Research Resource Nexus highlights the Immunologic Monitoring and Cellular Products Laboratory (IMCPL), a FACT-accredited, FDA-registered* good manufacturing practice (GMP) facility dedicated to advancing cell and gene therapy (CGT) from early development through clinical translation. IMCPL operates nine GMP clean rooms and a quality control (QC) analytics laboratory at The Riviera in the Pittsburgh Technology Center. In collaboration with the Advanced Cancer Cell Therapies facility at UPMC Hillman Cancer Center in Shadyside, IMCPL enables end-to-end clinical trial support for product logistics and bedside administration of more than 30 CGT products, targeting cancer, autoimmune and rare diseases across phase 1-3 trials.
IMCPL is a unique Pitt Health Sciences core facility available to Pitt investigators because it is designed to operate as an industry partner. Led by Director Devanjan Sikder and Associate Director Brigitte Senechal, the facility integrates regulatory and quality systems with GMP manufacturing and scientific expertise to support CGT product development. This includes generation of rigorous chemistry, manufacturing and controls (CMC) data for investigational new drug (IND) applications, as well as product delivery and longitudinal monitoring of immunologic function in clinical trial participants.
From Concept to Clinic: IMCPL’s Path to CGT Development
IMCPL supports investigators in translating CGT discoveries into clinically ready products through a structured, GMP-aligned process:
- Concept and feasibility: project onboarding to define scope, assess technical and regulatory feasibility, and establish quality and regulatory strategies
- Process development and optimization: transfer of research processes to the GMP platform, with readiness activities to support compliant scale-up
- Process qualification and validation (PQR): execution of PQR runs to demonstrate process consistency, reproducibility, and compliance, supported by analytics and stability testing
- IND readiness and regulatory submission: generation of GMP-validated production data and CMC documentation to support IND submission and clinical-phase manufacturing, including FDA negotiations
IMCPL’s manufacturing capabilities include a variety of CGT products, such as CAR-T cells, TCR-engineered cells, dendritic cell-based vaccines, gamma delta T cells, tumor-infiltrating lymphocytes and gene therapy. A dedicated QC laboratory performs testing for identity, composition, potency, stability and safety, as well as immunomonitoring assays to support clinical trials. For faculty with proof-of-concept data in animal models who are interested in translational or clinical CGT research, early engagement with IMCPL is strongly encouraged to help derisk development and align experiments with clinical scale-up requirements.
For more information about cell and gene therapy, ongoing clinical research and additional resources, visit the IMCPL website or email IMCPL@pitt.edu for consultations.
Selected Projects
Udai Kammula, professor of surgery, School of Medicine, and director of the Solid Tumor Cellular Immunotherapy Program at UPMC Hillman Cancer Center, developed a personalized adoptive cell therapy using tumor infiltrating lymphocytes. In this approach, T cells are isolated from a patient’s tumor, activated and expanded ex vivo up to 100 billion cells, and reinfused to target cancer cells with high specificity. This strategy has demonstrated rapid and durable responses in patients with rare and hard-to-treat cancers and depends on careful selection, expansion and handling of living cells. To support this classic bench to bedside model, Kammula has collaborated closely with IMCPL, first bringing his T cell manufacturing techniques in 2017, and continuously working with the team to translate laboratory discoveries into clinical-grade therapies. This close, transparent collaboration, unlike the “black box” nature of industry partnerships, has enabled real-time learning from each patient, rapid scientific progress and the production of dozens of personalized cell products. For Kammula, IMCPL provides a rare academic platform that supports continuous innovation, direct clinical feedback and the development of cell therapies as true “living drugs.” Learn more about his immunotherapy program in this video.
Gary Thomas, professor of microbiology and molecular genetics, School of Medicine, has spent more than 20 years studying the PACS1 gene and is now translating that work toward a treatment for PACS1 syndrome, a neurodevelopmental disorder caused by a single nucleotide mutation in one of the two PACS1 alleles. Thomas’ research demonstrated that silencing the mutated gene could restore normal neuronal structure and function in animal models, leading to the development of an experimental antisense oligonucleotide (ASO) therapy. This work was featured in the fall 2025 issue of PittMed, which followed the story and eventual approval of a treatment for a young child who will receive ASO therapy at UPMC Children’s Hospital of Pittsburgh thanks to the efforts of many at Pitt including Gerald Vockley, professor of pediatrics, School of Medicine, and of human genetics, School of Public Health, and director for the Center for Rare Disease Therapy. While effective, the current ASO therapy targets both mutant and healthy PACS1 proteins and requires repeated intrathecal delivery via spinal tap injections every three months. Building on this momentum, Thomas has begun a collaboration with IMCPL to design a gene therapy that precisely corrects the disease-causing allele, ensuring only the normal PACS1 allele is produced and maintained at normal levels, potentially correcting the disease from a single treatment. Although still in the early stages, this initiative aims to create a scalable, industry-aligned pathway to accelerate access to lower-cost gene therapies, with PACS1 serving as a model for other rare genetic diseases.
*Foundation for the Accreditation of Cellular Therapy (FACT) accreditation confirms that a cellular therapy program meets established standards for quality, safety and continuous improvement in patient care. U.S. Food and Drug Administration (FDA)–registered good manufacturing practice facility status indicates compliance with federal manufacturing and quality standards to ensure product safety, consistency and reliability.