Jiangxi Chiyan can provide customers with a full range of CRDMO services such as ADC Payloads synthesis, ADC pharmacodynamic evaluation, ADC pharmacokinetic evaluation and ADC safety evaluation.
After years of research and accumulation, Jiangxi Chiyan has formed its own compound library, which has a variety of chemical ADC payload molecules with different mechanisms for customers to choose, and can customize the synthesis of one or several ADC drugs that customers specific needs.
Efficacy test of ADC drugs in animal is an important pharmacological parameter in ADC drug research, which directly reflects the efficacy of ADC drugs and influences the design of clinical trials. Jiangxi Chiyan is committed to providing customers with mature tumor models and other models for evaluating the efficacy of ADC drugs in vivo, modeling and feeding model animals in AAALAC certified environment, and completing related pharmacodynamic evaluation tests in accordance with GLP-like and CGMP high standards.
Due to the complex composition of ADC drugs, their PK characteristics must be evaluated by multiple analytes, which increases the difficulty of analysis. Jiangxi Chiyan provides a variety of high-quality test methods for various ADC component analytes in the in vivo analysis of ADC drugs, and provides customers with reliable and high-quality PK data by analyzing plasma/serum samples collected in animals.
待测物 | 描述 | 常用分析方法 |
Conjugated Antibody | 至少偶联一个药物的抗体 | LBA |
Total Antibody | 全部偶联、部分偶联以及未偶联的抗体 | LBA |
Small Molecules | 游离或被稀释的药物小分子及其代谢物 | LC-MS/MS |
ADA | 可特异性结合ADC分子及其部分结构的抗体 | LBA |
Our experimental results can be benchmarked to international test standards and are consistent with the conclusions drawn by laboratories such as the United States.
Following the ICH Guiding principles S6 and S9, the relevant Toxicology Research Department of Jiangxi Intelligent Research Institute customizes the safety evaluation program according to the specific situation of each project, and provides safety evaluation services in line with international GLP standards such as NMPA, FDA, OECD and TGA, including:
Single and repeated administration toxicity tests (accompanied by toxicokinetic studies); Safety pharmacology (including tissue cross-reactivity);
Immunogenicity test.