ADC Analytical Services

Robust analytical services and quality control offerings tailored to the unique realities of bioconjugation

Harnessing analytical expertise within ADC discovery, development and clinical manufacturing

With the complex nature of antibody drug conjugates, analytical testing is imperative to successful ADC discovery, development and clinical manufacturing.

 

At Sterling, the analytical team at our dedicated ADC facility delivers expertise in both analytical services and quality control tailored specifically to bioconjugation programmes. With extensive backgrounds in biopharmaceuticals and biochemistry, our analytical team performs comprehensive analyses on ADCs to fully understand potency and other key attributes. In turn, we empower our customers to develop high-quality, highly effective therapeutics. ... Read more

 

Our analytical capabilities for ADC manufacturing

  • Complete analytical development packages including raw material, in-process and release tests
  • Analytical method validation according to ICH
  • Drug substance and drug product/cGMP lot release testing
  • Drug substance and drug product/cGMP stability
  • Environmental monitoring
  • Cleaning methods

 

With deep expertise in biochemistry, bioassays, microbiology, and analytical testing, we have the capabilities needed to support a range of projects in ADC analysis. Our purpose-built facilities provide the high level of containment needed to safely handle toxic materials while working with ADCs, and our team is committed to working closely with customers to fully understand their project requirements and maximise their success. Read less

  • Chromatography (SEC, HIC, PLRP, IEX HPLC/UPLC)
  • Capillary electrophoresis (cIEF/CE-SDS)
  • Charge heterogeneity (icIEF)
  • Immunoassays (ELISA)
  • Cell based potency assays
  • Spectrophotometry (UV-SoloVPE)
  • Mass spectrometry
  • Microbiology (Bioburden/endotoxin)
  • Cleaning (TOC, conductivity)
  • Residual solvents (GC)
  • Forced degradation
  • Purity and impurity profiling
  • Comparability
  • DAR determination
  • Conjugation site analysis (MS, PRLP and HIC)
  • Reference standard characterisation and qualification
  • Pre-formulation/formulation development
  • Clinical in use

Related Services

Related Content

Animation

ADCHigh Potency API

Antibody drug conjugates (ADC): The magic bullets

News

API Development

FDA approves ADC supported by Sterling

Related Pages

ADCs

Deeside, UK

PDMO