Potency and stability tests are necessary to ensure the quality, efficacy, and safety of biopharmaceutical products. Creative Biolabs has organized many outstanding scientists who have engaged in immune checkpoint research and immunotherapy development for many years. Our seasoned scientists have developed a full range of cell-based assays for a variety of immune checkpoint targets. Our assay can be used for antibody screening and characterization, potency and stability determination, and lot release.
Importance of Potency and Stability Assays
Immunotherapy is one of the most significant paradigms shift in cancer treatment history. The exquisite specificity and potency of the immune system are unleashed to destroy different types of malignancies. Many immune checkpoint modulator-based cancer immunotherapy approaches aim to unmask the cytotoxic effector function of the innate and adaptive immune systems to recognize and destroy malignant cells. Although immunotherapy holds promise for treating certain cancers, significant challenges remain in the clinical translation to many other types of cancers. Therefore, there is an urgent need for functional potency and stability assays that could model the complex interaction of the target cell and the effector molecule and can be used to rapidly test the efficacy of different immunotherapy strategies.
Immune Checkpoint Potency and Stability Assays at Creative Biolabs
Since cell culture-based assays measure the physiological response elicited by the product and generate results within a relatively short period, these assays are often the preferred format for determining biological activity. Moreover, cell-based potency assays are functional assays used for product release and stability programs. Creative Biolabs has developed a range of cell-based bioassays for various immune checkpoint targets, including PD-1/PD-L1, CTLA-4, LAG-3, TIGIT, CD40, OX40, GITR, and 4-1BB. Whether you are targeting co-stimulatory or co-inhibitory immune checkpoints, our industry-leading bioassays can accelerate your immune checkpoint drug development.
A variety of immune checkpoint targets available
Potency and stability assay development, transfer, and optimization
Phase-appropriate method validation
Lot release potency testing
Real-time stability testing
Scientists at Creative Biolabs are experts in performing cell-based potency and stability assays for a variety of immune checkpoint targets. We also offer high-quality service for bioassay development, transfer, and optimization for the determination of potency and stability. For more detailed information, please feel free to contact us or directly send us an inquiry.
All listed customized services & products are for research use only, not intended for pharmaceutical, diagnostic, therapeutic, or any in vivo human use.