Cell & Gene Therapy: Why Work with Charles River?
Cell and gene therapy development is an evolving, complex, competitive arena. Get your therapy to market faster with fewer roadblocks with the help of a proven partner who can support you every step of the way. With over 70 years of experience, Charles River Laboratories has a unique and comprehensive portfolio to support the development and execution of cellular and gene therapy programs from basic research to discovery and safety testing through to clinical and CMC testing support.
- Our global sites offer immunodeficient rodent models, large animal models, neonates, surgically altered models and tumor/syngeneic models for discovery and/or safety studies.
- Many cell and gene therapy programs include a single combined pharmacology and safety study, so it is beneficial to partner with a provider with sites that perform both efficacy and safety services, collaboratively. Charles River is the only CRO with a network of integrated sites offering these services.
- Our discovery portfolio offers a range of in vivo proof of concept models including inflammatory, CNS, metabolic, and bone healing models as well as CNS studies, human tumor xenograft studies and in vivo imaging leveraged for these highly specialized programs.
- All cell and gene therapy programs require bioanalytical, immunogenicity and/or biodistribution assessments all of which we can perform across multiple sites globally.
- Our sites in North America and Europe offer pilot studies for cell engraftment, tolerability or surgical administration, GLP toxicology assessments and GLP tumorgenicity studies.
- Our global team of pathologists perform multiple techniques crucial to the success of cellular and gene therapy programs including histopathology, immunohistochemistry, image analysis, molecular pathology and various PCR – based methods.
- Our scientific staff has extensive expertise in flow cytometry and molecular biology techniques and methodologies as well.
- Our scientific advisors, including a former FDA reviewing pharmacologist from the Centers for Drug Evaluation and Biologics Evaluation (CDER & CBER), have a deep understanding of regulatory expectations to help design the best strategy to advance a cellular or gene therapy program, a crucial attribute of your outsourced partner, as reviewers at CBER/FDA highly encourage pre-pre-IND meetings for these types of programs.
- Not only can we assist with your IND filing, but we can also identify clinical trial risk mitigation steps, establish clinical biomarkers to address translation gaps, and prepare for BLA filing.
- We have the unique ability to perform simultaneous CMC, efficacy, and safety testing for biologic products.
- As part of an integrated package of expert analytical services, we offer an extensive array of AAV testing services for a viral gene therapy or a viral vector needed to perform the efficacy/safety testing for a cellular therapy program.
- Our biologics testing sites work closely with our safety assessment sites for cell bank creation and storage, process evaluation for viral clearance, cell bank and product characterizations as well as release testing.
- CRL is offering through its strategic partner, PathoQuest, premium advanced next generation sequencing (NGS) QC solutions that supplement or replace traditional methods and support the strategic decision-making process with faster turnaround times in GLP and GMP environments.
- Endosafe® endotoxin testing employs the most reliable and sensitive test methods and platforms to meet the needs of your lab. Our Endosafe® nexgen-PTS™ provides a rapid method for endotoxin detection that is crucial in quality control release testing and time-sensitive release of cell products.
- Our Accugenix® microbial identification products and services offer validated, reliable quality control solutions to provide the most accurate identifications of relevant environmental isolates to ensure confidence in the production of contamination-free products released to market, support risk management decisions, and guarantee patient safety.
- Receive contamination results in just three days as opposed to the compendial two weeks with the Celsis Adapt™ Concentrator and Celsis Adapt™ Cell Reagent Kit. The system removes production cells and debris, leaving only potential bacterial, fungal, and mold contaminants behind, allowing for rapid analysis and product release. Celsis® can serve as your complete solution for quality control micro testing to deliver your cellular therapy safely to patients as quickly as possible.