CMC Consultancy – Biologics

ICON provides comprehensive, integrated CMC services with a global perspective for  your biologics products. With proven technical expertise in the design of biologics CMC strategy and hands-on resources to manage its implementation, ICON supports all phases of development. Our team are adept at designing and delivering CMC programs to take candidates from discovery to early clinical trials, through scale up and optimisation, to process validation and registration.

Our approach is flexible and collaborative, whether providing a single piece of strategic technical consultancy, or joining your project team for the design and implementation of your CMC strategy. Clients rely on our independent and objective analysis to ensure that projects meet the required technical and quality objectives, on time and within budget.

We work with clients to define the most streamlined CMC program for each product, to identify issues as they arise, manage the unexpected, and keep the project on track. Our experience covers:


  • Mammalian & microbial expression systems
  • Recombinant proteins and peptides
  • Monoclonal antibodies and antibody fragments
  • Modified proteins and conjugates
  • QbD strategy and development continuity planning
  • Upstream & downstream process development
  • Fill finish & lyophilisation development
  • Technology transfer & manufacturing management
  • Lean Six Sigma methodology & continuous improvement
  • Troubleshooting and risk analysis


  • Development plans
  • Fully integrated with other functions
  • Regulatory CMC strategy (IND/CTA to BLA/MAA)
  • Technical due diligence (in/out licensing)
  • Technical consultancy
  • Selecting & managing the ‘best fit’ suppliers


  • Process optimization and scale up
  • Process understanding and DoE studies
  • Scale down challenge studies
  • Critical Quality Attribute (CQA) assessment
  • Design space definition
  • Technical writing of CMC dossiers


  • QC release method development
  • Stability indicating method development
  • Characterization method development
  • Method transfer and validation
  • Formulation development
  • Stability testing
  • Analytical comparability strategy