Antibody Drug Conjugates (ADC) comprise a new class of anti cancer drugs. They consist of monoclonal antibodies, which are chemically linked to cytotoxic small molecule payloads such as Auristatin, Maytansinoid or other chemotherapeutic agents. Linkage can be either chemically for example through covalent coupling to amino groups of lysine residues or thiol groups of cysteine residues or even through site specific enzymatic linkage.
Quality control of ADC on the level of protein, linker, linker with payload, free payload and intact conjugate level is crucial for monitoring of production process and assessment of product safety.
Protagen Protein Services (PPS) is experienced in handling proteins and highly potent protein conjugates by combining state-of-the-art separation technologies with mass spectrometry.
Analytical support throughout ADC development
PPS has extensive experience in analysis of different formats and can successfully support you with:
- Developability assessment of candidates
- Detailed Structural Characterization
- Development, Qualification up to Validation of specific analytical methods
- Stability Testing
- Release Testing
PPS is continously developing new methods for ADCs and is offering services for ADC analysis like:
- Determination of drug antibody ratio (DAR) by intact mass analysis
- Purity and integrity analysis by CE-SDS and cIEF analysis
- Identification of linker sites by peptide mapping mass spectrometry
- Assessment of quantity by amino acid analysis and liquid chromatography (HIC, RP-HPLC, IEX)
- Aggregation analysis by SEC-MALLS and Analytical Ultracentrifugation (AUC)
- Glycosylation analysis by mass spectrometry, HILIC-FL and HPAEC-PAD
- Mass spectrometric assessment of free thiol groups and disulfide bridges
- Determination of molar extinction coefficient
- Specific functional and potency assays on request