Antibody-Drug Conjugates
Antibody-Drug-Conjugate Development
Antibody drug conjugates (ADCs) are the emerging class of anti-cancer therapeutic drugs. ADCs combine an antibody capable of recognizing cancer cells and cytotoxic small-molecule drugs via cleavable or non-cleavable linkers, thereby transforming the 3-unit combination into a targeted therapeutic drug for cancer treatment. In recent years, ADCs have rapidly developed and there are not only more than 14 approved drugs on the market but also many investigational drugs undergoing clinical trials. Furthermore, ADCs have shown potential for treating various diseases beyond cancer, such as Autoimmune disorders, Infectious diseases, Inflammatory conditions and so on.
By leveraging the existing mature protein drug manufacturing and analysis technology platform, Mycenax combines antibody and small molecule drug technology to expand its CDMO services into the ADC field. Mycenax and strategic partners offer a comprehensive one-stop ADC service, covering the process development from antibody modification, small molecule drug synthesis, biochemical conjugation, to analysis, characterization, and PIC/S GMP production, and provide customers with effective assistance in ADCs development.
1. Diversified ADC technology combinations
ADCs encompass a wide range of technologies, such as antibody genetic engineering, antibody modification, linker technology, conjugation techniques, and more. Mycenax and strategic partners provide diversified services, selecting one or more combinations of technologies based on the specific requirements of ADC designs.
2. Services tailored to meet the needs of different development stages
I. Feasibility study: Based on Mycenax existing ADC platform, we can rapidly provides small quantities of 20-200mg ADC samples for candidate drug selection. Additionally, we offer appropriate documentation tailored to meet customer requirements for preclinical testing and research, enabling the identification of candidate drugs.
II. Process development: Mycenax conducts process parameter studies based on OFAT (One Factor at a Time) or DOE (Design of Experiments) approaches, using scale-down model to investigate and establish a scalable and stable manufacturing process. Before transferring the process to the PIC/S GMP production line, we stepwise scale up the process in the laboratory to 5L to verify the established process.
III. PIC/S GMP production: The process is transferred from the laboratory to the production line compliant with PIC/S GMP standards to manufacture the target drug for clinical trials.
2023 World ADC Poster: Control of Drug-to-antibody Ratio in Cysteine-based Conjugation ADCs
OUR STRATEGIC PARTNERSHIPS
KriSan offers small molecule drugs, linkers, payloads, and GMP production for ADC drugs for Mycenax’s global
Antibody-Drug Conjugates CDMO business.
Mycenax and KriSan announce a collaboration to strengthen their one-stop service chain for ADC – read our press release.
Keyword: Antibody-Drug Conjugates, Antibody Drug Conjugate, ADC, linker, payload, linker-payload, CDMO, CMO, GMP manufacturing
Antibody-Drug-Conjugate Development
Antibody drug conjugates (ADCs) are the emerging class of anti-cancer therapeutic drugs. ADCs combine an antibody capable of recognizing cancer cells and cytotoxic small-molecule drugs via cleavable or non-cleavable linkers, thereby transforming the 3-unit combination into a targeted therapeutic drug for cancer treatment. In recent years, ADCs have rapidly developed and there are not only more than 14 approved drugs on the market but also many investigational drugs undergoing clinical trials. Furthermore, ADCs have shown potential for treating various diseases beyond cancer, such as Autoimmune disorders, Infectious diseases, Inflammatory conditions and so on.
By leveraging the existing mature protein drug manufacturing and analysis technology platform, Mycenax combines antibody and small molecule drug technology to expand its CDMO services into the ADC field. Mycenax and strategic partners offer a comprehensive one-stop ADC service, covering the process development from antibody modification, small molecule drug synthesis, biochemical conjugation, to analysis, characterization, and PIC/S GMP production, and provide customers with effective assistance in ADCs development.
1. Diversified ADC technology combinations
ADCs encompass a wide range of technologies, such as antibody genetic engineering, antibody modification, linker technology, conjugation techniques, and more. Mycenax and strategic partners provide diversified services, selecting one or more combinations of technologies based on the specific requirements of ADC designs.
2. Services tailored to meet the needs of different development stages
I. Feasibility study: Based on Mycenax existing ADC platform, we can rapidly provides small quantities of 20-200mg ADC samples for candidate drug selection. Additionally, we offer appropriate documentation tailored to meet customer requirements for preclinical testing and research, enabling the identification of candidate drugs.
II. Process development: Mycenax conducts process parameter studies based on OFAT (One Factor at a Time) or DOE (Design of Experiments) approaches, using scale-down model to investigate and establish a scalable and stable manufacturing process. Before transferring the process to the PIC/S GMP production line, we stepwise scale up the process in the laboratory to 5L to verify the established process.
III. PIC/S GMP production: The process is transferred from the laboratory to the production line compliant with PIC/S GMP standards to manufacture the target drug for clinical trials.
2023 World ADC Poster: Control of Drug-to-antibody Ratio in Cysteine-based Conjugation ADCs
OUR STRATEGIC PARTNERSHIPS
KriSan offers small molecule drugs, linkers, payloads, and GMP production for ADC drugs for Mycenax’s global
Antibody-Drug Conjugates CDMO business.
Mycenax and KriSan announce a collaboration to strengthen their one-stop service chain for ADC – read our press release.
Keyword: Antibody-Drug Conjugates, Antibody Drug Conjugate, ADC, linker, payload, linker-payload, CDMO, CMO, GMP manufacturing