Antibody-Drug Conjugate (ADC) CRDMO Service

Rochi Pharma can provide Synthesis of ADC Payloads、Pharmacology Evaluation of ADC、ADC Pharmacokinetics Study、ADC Safety assessment CRDMO Service.
Synthesis of ADC Payloads:
After years of research and development, Rochi Pharma has formed its own compound library, in which there are a variety of chemical ADC payload molecules with different mechanisms of action for customers to choose, and at the same time, it can customize and synthesize one or several ADC drugs specifically required by customers.
Pharmacology Evaluation of ADC:
One important pharmacological parameter of an ADC is the in vivo efficacy that directly reflects its potency and influences clinical trial designs. Rochi Pharma is committed to providing oncological models and other models for ADC efficacy assessment Our animal models are all established and maintained under the regulation of AAALAC. Our tests are conducted with GLP-like and C-GMP standards.
ADC Pharmacokinetics Study:
ADC raises the difficulties of PK study for each component ADC molecules owning unique PK characteristics. Rochi Pharma provides high quality quantification assays for key parameters in ADC PK study, presenting accurate results.

PK and TK:
Benchmarking with global lab standard for results with high consistency，consistent with the conclusions drawn by laboratories in the United States.
ADC Safety assessment:
Rochi Pharma offers rigorous and specific safety assessment services strictly following S6 & S9 Regulation of ICH and in compliance with the requirement of NMPA, FDA, OECD and TGA.
Single dose/Repeat dose toxicity (With TK)；
Tissue cross-reactivity；
ADA test.