CAR-T Safety Testing Services

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.

CAR-T Safety Testing Capabilities

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	Sterility Mycoplasma Pyrogens, endotoxins Adventitious virus Residual virus/provirus Viral Replication competency Tumorigenicity	Residual host cell DNA (cell and target specific) General safety Sterility Mycoplasma Pyrogens, endotoxins Adventitious virus Viral Replication competency	Sterility Mycoplasma Pyrogens, endotoxins

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)

A Glance of Highlighted Services

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.

Cell Banking Service: Create a cell bank that supports virus production
Copy Number: The copy number of nucleic acid target molecules can be quantitatively determined. The Q-PCR assay is commonly used as an identification assay.
Bacterial residual DNA/RNA: Bacteria represent the main source of large quantities of plasmids that support virus production. Evaluate and determine the amount of natural bacterial nucleic acid per milligram of the final product.
Fluorescence in situ hybridization (FISH): In situ hybridization is a powerful tool for locating DNA sequences. This technique is very sensitive and can routinely detect sequences of several thousand bases long. The relative copy number distribution of sequences present at more than one site can be determined.
Plasmid integrity: By measuring the total percentage of supercoiled DNA relative to the total open/nicked plasmid, assess the determination of plasmid integrity after preparation/purification.
Plasmid retention/residue: It is determined by propagating the microbial cell line on a suitable antibiotic selection medium, and then determining the percentage of the total plated cells that survive.
Quality of Design (QbD) Service: We can work with you to design and execute customized biosafety testing procedures-from the testing of input materials to the subsequent design of molecular and analytical solutions that support downstream applications and final product release.
Residual host cell analysis: The detection and quantification of residual host cell nucleic acid and protein are carried out by methods based on molecular biology. If the gene therapy vector is produced in a human cell line, it may involve size selection.
Stability: Customized test kits can evaluate the physical and chemical properties, identity and efficacy of gene therapy vectors after short, medium and long-term storage (usually up to 5 years).
Virus manufacturing: From pre-clinical development to manufacturing and filling/finishing, our state-of-the-art GMP facilities can support the production of adenovirus, adeno-associated virus, lentivirus, herpes virus, vaccinia, reovirus, coxsackie, dengue fever, and letter Debis's therapeutic viruses, retroviruses, alpha viruses and many other viral products.
Viral replication competency: determination/detection of viral gene therapy vector replication.