ADC(항체-약물 접합체) 제작 서비스 | 고마바이오텍

특징 

• 고객이 제공한 항체를 사용하여 CellMosaic®에서 소규모로 정제 및 특성화된 ADC를 제조해 드립니다. 
• In vitro 초기 연구를 위한 소규모 제작 및 in vivo 연구를 위한 30-200mg (혹은 그 이상) 규모의 ADC 제조를 제작해 드립니다.

서비스 종류 

▒ Routine Small-Scale ADC Synthesis

• 제공되는 내역  
• aliquoted product 
• COA with HIC HPLC (if selected) and SEC HPLC data  
• MALDI-TOF MS data (if selected)
• ADC concentration
• DAR value if available 

• 서비스 포함 사항
• Labor and materials (excluding antibodies)
• Initial QC and quantitation of the starting antibody by SEC HPLC
• In-process reaction monitoring
• Final ADC analysis by SEC HPLC to check the purity and aggregation profile and determination of the concentration
• DAR estimation based on UV analysis. *
• ADC formulation with CellMosaic's ADC stabilizer. 
• Sterilized buffers and plasticwares are used for preparation.
• Aliquot equally up to 5 tubes (equal volume per tube).
• *Note: Mc-MMAF does not have a characteristic UV absorbance that allows calculation of DAR by UV.

▒ Routine Medium and Large-Scale ADC Synthesis 

• 제공되는 내역  
• aliquoted lyophilized product 
• COA with HPLC data, MALDI-TOF MS data
• DAR value 

• 서비스 포함 사항
• Labor and materials (excluding antibody).
• All HPLC analysis (HIC, SEC, or any other HPLC type) that determined necessary for QC materials, in-process analysis, and final product characterization. 
• MALDI-TOF MS analysis of the starting antibody and ADC if the MW of starting antibody is ≤150KDa.*
• Small scale testing reaction (10-20 times scaling down) to check the loading and ADC properties.
• Gel column purification to remove unreacted drugs.
• ADC formulation with CellMosaic's ADC stabilizer. 
• ADC conjugation under low endotoxin free environment: Endotoxin free water, biological grade chemicals, sterilized buffers, certified pyrogen-free pipette tips/tubes, columns/filters/resins are cleaned prior usage. 
• Endotoxin Free Lyophilization: Final product will be sterile filtrated, aliquot into non-pyrogenic/sterilized lyophilize vials (5 mg per vial), lyophilized, and sealed under N2 atmosphere.
• *Note: some ADCs may not be ionized well resulting in poor quality MS data. Drugs conjugated with some releasable linkers may fall off during ionization resulting in artificially low DAR data.