All products and services are For Research Use Only and CANNOT be used in the treatment or diagnosis of disease.
Cell therapy based drugs are experiencing a resurgence due to the introduction of "next-generation" transfer vectors, which have proven to have higher safety and efficacy. Creative Biolabs collaborates with our customers who focusing on cell therapy, and using our technical testing expertise and the highest level of quality to meet their testing needs. Patient cells are usually extracted, expanded, and transduced using gene therapy vectors, and then re-implant the modified cells into the patient to achieve therapeutic effects. In this case, the modified cell is a drug product, not a gene transfer vector, and is accompanied by unique regulatory challenges.
Given the complexity associated with new technologies, effective and efficient communication channels are often the determinant of the success of a test or manufacturing plan. Creative Biolabs always keep our customers at the center of the organization in the Creative Biolabs'charter. We do this through effective communication through integrated project management, customer management, development services, and laboratory operations. We provide comprehensive assays and services to support all stages of CAR-T cell therapy development - from the production of viral vectors to extensive biosafety testing following specified regulatory guidelines. Our first-class GLP and GMP safety testing is offered with leading turnaround time and scientific expertise. Our people all are trained and dedicated to providing you the best quality of service.
Our state-of-the-art facilities are well equipped to meet customers'virus product manufacturing and biosafety testing needs. Creative Biolabs provides a series of testing methods that support CAR-T cell therapy - conventional (mycoplasma, sterile) and custom designs (identity, potency testing) that meet all clinical and regulatory compliance standards. These tests are supported by our cGMP-level manufacturing and testing facilities and dedicated laboratory operations to ensure the highest quality and turnaround time.
Test Items | CAR-T Cell Therapy | CAR-T Therapy Product | |
Viral | Non-viral | ||
Safety |
|
|
|
Coupled with our cGMP grade manufacturing and testing facility, we also provide a comprehensive range of CAR-T cell characterization assays to meet your gene and cell therapy manufacturing and testing needs on a global scale.
Test Items | CAR-T Cell Therapy | CAR-T Therapy Product | ||
Viral | Non-viral | |||
Identity |
Surface marker determination DNA fingerprinting; STR analysis Species Morphology Bioassay Biochemical marker |
Restriction enzyme mapping PCR/Q-PCR Immunoassay (transgene) DNA sequencing |
Restriction enzyme mapping PCR/Q-PCR Immunoassay (transgene) DNA sequencing |
|
Potency |
Viability Titer Bioassays include colony formation and functional transgene expression |
Functional transgene expression | Functional transgene expression | |
Purity |
Cell viability Transduction efficiency Functional transgene expression (targeted cell) Process contaminants |
Residual host cell DNA/RNA Residual host cell protein Process contaminants Helper virus contamination Vector integrity (defective/immature particles) |
Plasmid integrity Residual host cell DNA/RNA Residual host cell protein Process contaminants (Solvents, salts, CsCl) Vector integrity (defective/immature particles) |
Creative Biolabs partners with our CAR-T therapy focused to design and execute customized biosafety testing programs – from testing of input raw materials to the subsequent design of molecular and analytical solutions supporting downstream applications and final product release. Routine and customized assays are offered for all the following major categories.
For any technical issues or product/service related questions, please leave your information below. Our team will contact you soon.
The latest newsletter to introduce the latest breaking information, our site updates, field and other scientific news, important events, and insights from industry leaders
LEARN MORE NEWSLETTERCellRapeutics™ In Vivo Cell Engineering: One-stop in vivo T/B/NK cell and macrophage engineering services covering vectors construction to function verification.
LEARN MORE SOLUTIONSilence™ CAR-T Cell: A novel platform to enhance CAR-T cell immunotherapy by combining RNAi technology to suppress genes that may impede CAR functionality.
LEARN MORE NOVEL TECHNOLOGYCanine CAR-T Therapy Development: From early target discovery, CAR design and construction, cell culture, and transfection, to in vitro and in vivo function validation.
LEARN MORE SOLUTION