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Quality Control for In Vivo Assays

Qualification and Credit

Creative Biolabs is dedicated to establish the most exquisite service platform for the in vivo study of CAR-T/TCR-T cell therapy. We aim to provide customers with services for the most qualified preclinical tests. From the foremost project design to the final data interpretation, Creative Biolabs implements strict inspections and validations on each and every step. We are able to conduct projects in standardized procedures that conform to the GLP (FDA/OECD) regulations, which are essential for the IND application.

Quality Control for in vivo Assays

GLP-compliant in vivo Assays for CAR-T/TCR-T Cell Therapy

Compared to the conventional GLP-compliant chemical analysis, more specifications are required for the test of CAR-T/TCR-T cell therapies, which includes but not limited to the following categories.

Animal species/models

Before model construction, Creative Biolabs will make a detailed evaluation on the feasibility to access the anatomic sites on animals for cell products administration and the delivery of specific dose during the whole test process.

Study design

In accordance to the general guidance from FDA, scientists of Creative Biolabs will provide our customers with a detailed service proposal specifying the contents including targeted cellular phenotypes, the source of the cells, the extent of ex vivo manipulation, the fate of the cells post-administration, the probability of a host immune response, administration site reactions, potential inflammatory response in target and/or non-target tissues, unregulated/dysregulated proliferation of the cells within the host.

Cell fate of CAR-T/TCR-T therapy post administration

Due to the fact that determination of cell fate in the investigational CAR-T/TCR-T cell therapy is a crucial step for the characterization of product activity and safety profile, Creative Biolabs established a series of strict criteria. Based on the specific needs of each project, we will perform multiple evaluations from the list of determination of cell survival/engraftment, cell distribution (in vivo imaging, PCR, IHC), cell differentiation and integration (cell morphology, phenotype, and level of differentiation), and tumorigenicity/dysplasia/hyperplasia observation (for a sufficient length of time).

Non-GLP Studies for Basic Research

Since GLP compliance is not a requirement for discovery, basic research, screening or any other studies in which the safety of the products is not assessed, Creative Biolabs also provides services for non-GLP studies. However, we will apply the rigorous criteria that have been established for study design, performance, monitoring and documentation as well in order to generate reliable and solid data for every research projects.

Animal species/models Evaluation on the feasibility to access the anatomica sites. Study design

• Targeted cellular phenitypes
• Cells source
Ex vivo manipulation
• Et al.

Cell fate of TCR-T therapy post administration

• Cell survival/engraftment
• Cell distribution
• Cell differentiation
• Tumorigenicity/hyperplasia

Non-GLP studies

• Study disgin
• Performance
• Minitoring
• Documentation

Featured Service

Creative Biolabs possesses the qualification to supply GLP-compliant in vivo service for the preclinical evaluation of CAR-T/TCR-T cell therapy and the capacity to satisfy our customers with timely and accurate compliance feedback.

Featured services provided by Creative Biolabs include the following categories.

  • GLP and non-GLP in vivo assay for CAR-T/TCR-T cell therapy
  • GLP-compliant CAR-T/TCR-T preclinical project design
  • IND application related experiment design
  • Method validation
  • Formal report generation

All services and products are only for lab research use, not for any clinical diagnosis or treatment.

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