Antibody Drug Conjugates Services

Antibody Drug Conjugates (ADCs) are monoclonal antibodies (MAbs) attached to cytotoxic / biologically active drugs by chemical linkers with labile bonds. By combining the unique targeting of MAbs with the cancer-killing ability of cytotoxic drugs, ADCs allow sensitive discrimination between healthy and diseased tissue.

With six marketed drugs(1), and 246 ongoing clinical trials(2), ADCs are presently recognized as a potent class of targeted anticancer therapies, with the potential to be used to treat a variety of other disease indications.

For Analytical Development of your ADC, SBH Sciences offers multiple platforms, including cell-based assays, and the innovative automated Simple Western Blot services using the PeggySue and WES (ProteinSimple), plus Flow Cytometry.

Using these platforms and services we can perform studies for:

  • Mechanism of Action (cell proliferation, apoptosis)
  • Drug potency
  • Fc-mediated action (ADCC, Antibody-dependent phagocytosis)
  • Flow cytometry - internalization assay, cell cycle arrest assay
  • Lot Release and Stability Testing
  • Batch-to-batch comparability
  • Purity (SDS-PAGE/capillary gel electrophoresis, size-exclusion chromatography)
  • Stability (chromatographic and electrophoretic methods)

Numerous analytes must be measured for the quantitative assessment of ADCs in serum or plasma:

  • Conjugated antibody
  • Total antibody (conjugated, partially conjugated, fully unconjugated)
  • Unconjugated (“free”) drug (detected by LC-MS)
  • Anti-drug antibody (ADA)

Ligand Binding Assays (ELISA) are ideally suited for the bioanalysis of ADCs and their component parts (except for free drug). For pre-clinical or clinical sample (plasma or serum) analysis, the services we can provide for your ADC program include:

  • PK/TK studies for ADCs
  • Immunogenicity assessment
  • Biomarkers
  • Long term stability

 

SBH Sciences has experience developing assays for immunogenicity, using a multi-tiered approach (screening, confirmatory, tittering, neutralization). Our scientists understand the complexity of ADCs and the development of assays required to measure total drug conjugates and naked molecules for PK analysis.

SBH Sciences is determined to maintain the highest standards and deliver the highest quality services. We welcome your suggestions and encourage you to communicate with us about your specific research requirements.

Streamline your ADC Development project by working with SBH Sciences.
To find out more please contact us today.

 

References
1. The six marketed ADCs are:
(a) Brentuximab vedotin (Adcetris, Seattle Genetics, Millennium/Takeda),
(b) Trastuzumab emtansine (Kadcyla, Genentech, Roche),
(c) Inotuzumab ozogamicin (Besponsa, Pfizer/Wyeth),
(d) Polatuzumab vedotin-piiq (Polivy, Genentech, Roche),
(e) Enfortumab vedotin (Padcev, Astellas/Seattle Genetics),
(f) Trastuzumab deruxtecan (Enhertu, AstraZeneca/Daiichi Sankyo)

2. According to ClinicalTrials.gov, Feb 25, 2020