CAR-T In Vivo Pharmacology - Creative Biolabs

CAR-T In Vivo Pharmacology With our experienced scientific, technical and regulatory experts, Creative Biolabs is able to assist in all preclinical facets of your cellular and gene therapy (CGT) program, including CAR-T animal model, CAR-T in vivo pharmacology and CAR-T toxicology, as well as study protocol design, assay development and validation, and various endpoints analysis.

Creative Biolabs provides preclinical pharmacological services for scientific consideration of properties and predictive clinical use of a CAR-T product. We support the preclinical development of the following product types for decades with our unique professional services.


Cellular Therapy Type		Gene Therapy Type
Stem Cell Derived	Mature/Functionally Differentiated
✔ Variable capacity for self- renewal. ✔ Able to differentiate into variety of cell types. ✔ Fate is determined mainly by milieu post administration.	✔ No self-renewing or differentiation.	✔ Non-viral vectors (e.g., plasmids). ✔ Replication-deficient viral vectors (e.g., adenovirus, adeno-associated virus (AAV), retrovirus, lentivirus, poxvirus, herpes simplex virus (HSV)). ✔ Replication-competent oncolytic vectors (e.g., measles, reovirus, adenovirus, vesicular stomatitis virus, vaccinia). ✔ Genetically modified microorganisms (e.g., Listeria, Salmonella, E. coli, Bacteriophage). ✔ Ex vivo genetically modified cells.

“Challenge, Change, Chance and Cheers”

In Vivo Pharmacology Services for Cellular and Gene Therapy Products

Creative Biolabs is committed to offering exactly what clients need with integrated solutions, accelerated timelines to make a difference. Our scientists are dedicated to helping our clients to overcome challenges, avoid risks, and expedite CGT drug development with a broad array of pharmacology studies, such as ADME, PK, PD, toxicology, MoA, etc. Individual studies and customized integrated solutions will be designed with our clients’ goals in mind. In addition, our regulatory experts will ensure that all studies meet global requirements for quality and compliance, which can smooth the path to market.

Key Considerations for Cellular and Gene Therapy


CT product fate post-administration	CT product with implantable scaffolds	GT product
Survival/engraftment Trafficking/migration Proliferation Biodistribution Differentiation and integration Tumorigenicity	Cells characterization Scaffolds Biocompatibility Cell seeding Biological responsiveness Dose response and durability of the response	Vector Biodistribution

Specific Studies for Cellular and Gene Therapy Products


Proof of Concept studies	☆ We offer POC studies to define the dose range and timing, optimize the route of administration, and characterize the mechanism of action.
Dose determination studies	☆ We provide appropriate models to help determine dose regimen and route of administration via measurements of biological activities.

Pharmacological Measurements for Cellular and Gene Therapy Products


✔ Cell phenotype	✔ Cell source	✔ Ex vivo manipulation
✔ Minimal effective dose	✔ Limiting dose	✔ Cell fate
✔ Possibility of host immune response	✔ Local and systemic toxicities

Endpoint Analysis Capabilities


✔ Clinical chemistry, coagulation and hematology	✔ Histopathology and immunohistochemistry	✔ Deep sequencing
✔ Replication-competent virus detection	✔ Neutralizing antibody assays	✔ Total and infectious titer assays
✔ High-throughput bioanalysis	✔ Immunogenicity	✔ Biomarker analysis

Considerations of Gene Therapy products


✔ Safety/activity via the intended clinical ROA	✔ Aberrant localization to non-target cells/tissues	✔ Level and/or persistence of vector and transgene expression
✔ Level of viral replication in non-target cells/tissues	✔ Inappropriate immune activation	✔ Immune response directed against the vector
✔ Phenotype/activation state of target cell(s)	✔ Potential for insertional mutagenesis and/or oncogenicity	✔ Transgene-related concerns

Technology Platforms

ELISA, ELISPOT, qPCR, Deep Sequencing Flow Cytometry, MSD, ICS, UPLC (Q-TOF/MS) HPLC, Q-Trap Mass Spectrometry (LC/MS/MS)

Additional Services

With decades of providing biosafety and analytical studies for a wide range of advanced CGT products, we also provide the following services.

Comprehensive program support for GMP cell banking (eukaryotic/mammalian) and cell line characterization;
GMP manufacture of cellular therapeutics;
Potency assays for cell- and gene-therapy-based products;
Genetic stability and characterization;
Assay development and validation;
Lot release;
Stability programs.

Our immunologists, molecular biologists, analytical chemists, and pharmacological experts ensure that we become an ideal partner for your CGT discovery and development. Creative Biolabs is committed to providing personalized consulting services in the current rapid development of regulatory landscape. Please contact us to know more information and a detailed quote.

For Research Use Only | Not For Clinical Use