Routine Medium and Large-Scale ADC Synthesis

Product Description

This routine synthesis is for medium to large scale (30-200 mg) preparation of purified and characterized ADC for in vivo studies. Customers provide their antibody to CellMosaic®, and CellMosaic® will supply the conjugate along with analysis data. Great care will be taken to ensure high quality ADC. For 3-10 mg scale ADC preparation for in vitro studies, please click here. For over 200 mg large scale ADC preparation, contact us for a quote.  

Customers can order this online by choosing from reaction scales, drug linkers, and other additional services.

Delivery: aliquoted lyophilized product plus a COA with HPLC data, MALDI-TOF MS data, and DAR value. 

Included in the price:

• 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.

Selections and Add-ons:

1. Reaction Scale: choose between 30 mg, 50 mg, 100 mg, and 200 mg antibody labeling scale. Final ADC recovery is usually 40-80% depending on the properties of the ADC. If you don't see the scale of the reaction, please contact us for a quote.
2. Drug+ Linker + Chemistry: choose from popular drugs in the market (MMAE, SN38, DM1, MMAF, Doxorubicin, Deruxtecan) with different linkers and labeling chemistry. if you don't see the drugs you are interested in, please contact us for a quote.
3. Aliquot: additional aliquot beyond 5 mg per tube will be charged at $25 per tube.
4. Optional Endotoxin Testing: chromogenic endotoxin testing at CellMosaic. The final endotoxin level will be reported. Total two samples: antibody and ADC. Additional samples or repeated testing will be charged at $100 per sample.
5. Additional Special HPLC Purification: there might be some unreacted antibodies present in an ADC with an average of 2-4 DAR. For ADC prepared via thiol reduced chemistry, it might be possible to separate different DAR conjugates using HPLC. In an event if customer wants to completely remove unreacted antibody and/or obtain only single DAR conjugates, please write down your HPLC purification need. Price will be adjusted later based on your need.

Special Request for Higher DAR:

Standard synthesis will target average 4 drugs per antibody molecule and can be ranged from 3 to 5 drugs per antibody molecule. Higher DAR may be requested later for Deruxtecan ADC with classical linker if your initial synthesized ADC does not have too much aggregation and precipitation.

For other drugs, higher loading can be requested with our proprietary super-hydrophilic sugar alcohol based AqT™ linker. Please contact us for a quote. Loading up to 6-8 drugs per antibody while still maintaining good solubility and biocompatibility are possible with AqT™ linkers. Click here to see an example of AqT™ ADC with 6.1 SN38. 

Requirement for Antibody

1. Preferably >90% pure by gel electrophoresis
2. The amount of the antibody supplied should be 1.2x over the asking reaction scale (protein content measured by UV). Unused antibody will be returned to the customer. 
3. Please fill out the antibody information such as MW, IgG type etc. and attach any QC document of the antibody if available.