Quality Control Laboratory (QCL)
Services Offered
1cafA pioneer in CAR T cell therapy, the Quality Control Lab (QCL) at the Clinical Cell and Vaccine Production Facility (CVPF) set the standard for the rigorous testing and acceptance criteria required for releasing cell and gene therapies to patients during the Penn-Novartis alliance that resulted in the first-ever CAR T cell therapy to receive FDA approval in 2017 (Kymriah). While the rest of the industry rushed to adopt these standards in the wake of our success, QCL at CVPF continued to pave the way for innovative clinical testing of cell therapy over the many years since. Whether it is through comprehensive sterility testing, advanced flow cytometry, or meticulous environmental monitoring of cGMP manufacturing facilities, the team at CVPF QCL ensures the utmost safety and quality of cell therapy products.
As the focus of CVPF shifted from high patient volume to branching out into dozens of different clinical trials utilizing different therapeutic approaches such as CRISPR editing, base-editing, bicistronic constructs, and combination therapy, QCL maintained current and cutting-edge methodologies to support the implementation of all these disparate clinical trials. Each year, numerous validation protocols and process improvements are executed by QCL, in addition to adoption of new technologies and assay development, to maintain CVPF’s position as a leading cell therapy manufacturing facility. Each of these validated SOPs and assays adheres to the highest standard based on USP guidance and documentation. As a FACT-accredited facility, CVPF QCL is proud to offer many of these services for external groups with the same stringent approach and diligent care that we provide internally.
In-House Testing Offered by CVPF QCL:
- Sterility (Aerobic & Anaerobic) via BD BACTEC FX Blood Culture System and BD EpiCenter Microbiology Data Management System
- Endotoxin Detection via Charles River Endosafe Nexgen-PTS system
- Mycoplasma Screening via BioFire FilmArray 2.0 Multiplex PCR and Lonza’s MycoAlert Plus
- Cell Viability via Luna FL Dual Fluorescnce Automated Cell Counter
- Cell Counting via Beckman-Coulter Multisizer 4e Coulter Counter
- Colony-Forming Assay via STEMVision Automated Colony Counter and Methocult Media Differentiation Assay
- Residual BSA ELISA via Cygnus Technologies BSA ELISA Kit and SpectraMaxM5 Microplate Reader
- Residual Beads Assessment via Microscopy
- Product Appearance via Adelphi Apollo 2 Liquid Viewer
- Flow Cytometry via Novocyte Quanteon (20 Parameter Multicolor Panels)
- Cell Phenotype, Activation, Viability, and Characterization
- Minimum Residual Disease (MRD)
- Transduction Efficiency of CAR
- Transfection Efficiency of Electroporation
- Editing Efficiency of CRISPR KO and Epitope-Editing
- Intracellular Staining
- Small Scale Test Expansion – Qualify New Patients and Donors
- Multiplicity of Infection (MOI) Titration – Determine Optimal Vector Quantity for New Clinical Trials and Reference Vector Control Cultures
- Reagent Qualification
- Cytokine Independent Growth Assay (Long Term Cultures) – Test for Malignant Cell Transformation in Products with Multiple Gene Editing/Modification Combinations
- Functional Potency: Luciferase Assay for cytotoxic activity and Cytokine Release Assay
- Stability (Vector/Products/Reagents/Cell Lines) –Testing of Cryopreserved Material to Ensure Consistent Quality Attributes over Time
- Cell Line Expansion
- Environmental Monitoring (EM) - Viable Air and Surface Particles via SAS Air Samplers and RODAC Plates, Nonviable Particulate Counts via Climet Particle Counter
- EM CFU Enumeration via Scan 500 Automatic Plate Counter
Consultation, Education and Training Services:
- Validation of Release Test Assays – Validation, Implementation, and Training of Any New Quality Assay Required for Clinical Products.
- Development of Complex Flow Cytometry Panels - Design, Optimization, and Validation of Multicolor Flow Cytometry Panels for All Time Points of Manufacturing from Apheresis to Harvest.
- Small Scale Cell Culture Training – Training on Cell Culture Required in Support of Large Scale Clinical Manufacturing: MOI Titrations, Test Expansions, Differentiation Assays, Positive Control Cell Expansion, Cell Line Maintenance, Long Term Cultures, Potency Assays
- GMP Gowning Training – Procedure for Donning PPE in GMP Cleanroom and Following Aseptic Technique for Sterile Manufacturing Rooms
- In-Process Environmental Monitoring – Training on Performing In-Process Sampling of Manufacturing Technicians and Cleanroom Spaces.
For additonal information please contact:
Anlan Dai
Phone: 215-898-5951
Email: anlandai@pennmedicine.upenn.edu
Contact Us
Clinical Cell and Vaccine Production Facility (CVPF)
Center for Advanced Cellular Therapies
9th Floor SPE/South Tower, Bldg. 421
3400 Civic Center Boulevard
Philadelphia, PA 19104
