Sterling’s dedicated specialists and state-of-the-art facility, based in Deeside, Wales, UK, are fully equipped to support bioconjugate research and development.

Our senior team possesses more than 35 years of experience in the field of bioconjugation, with a specialised focus on antibody drug conjugations (ADCs). Through partnering with Sterling, you can gain access to some of the world’s leading experts in this field, in addition to specialist capabilities outlined below:

Antibody Drug Conjugate (ADC) capabilities

Our technical Antibody Drug Conjugation (ADC) capabilities

ADC technical capabilities overview

Proof of Concept: Fast, reliable, high quality and tailored to meet your needs

Customer antibody/target

  • Various conjugation approaches, such as cysteine, lysine, enzymatic
  • Generation of different DAR conjugates
  • Multiple toxin classes available
  • Cleavable and non-cleavable linkers
  • Platform analytics and certification or customised to your needs

Client payload

  • Model antibodies available
  • Linker design for novel payloads

Scale, purification and analysis

  • Milligram to 100s milligram scale
  • Membrane and chromatographic purification as required
  • Certified ADCs: minimally DAR, monomer, concentration and residual toxin
  • Additional analysis, including mass spectrometry, iEF, CE-SDS endotoxin, bioburden

Process development: Proven track record in development of GMP ready processes

  • QbD approach exploiting experience, DOE and OFAT methods
  • Optimisation of reactive stages, including chemical and enzymatic
  • Development of supporting purification methods
  • Phase appropriate robustness studies
  • Process characterisation

Pre-clinical batch manufacture

  • Batch preparation and certification for pre-clinical animal studies
  • Milligram to multi gram scale

Supporting activities

  • Liquid formulation screening/development
  • In vitro stability
  • Developability assessment

 

As a partnership development and manufacturing organisation (PDMO), we are committed to harnessing our simple and collaborative way of working to help accelerate delivery of these innovative drugs to patients. Our team of experts can help support your project through discovery to pre-clinical scale up, in addition to helping proactively overcome ADC challenges.

Want to know more? Contact an expert here.