CMC - Biologics

ICON's CMC team has extensive experience in recombinant protein development using mammalian and microbial expression systems. Our team provides technical expertise for design of your biologics CMC strategy and hands-on resources to manage the developmental activities from preclinical to commercial launch.

Our CMC biologics experts have worked with a wide range of Cell and Gene Therapies and Advance Therapy Medicinal Products as well as recombinant products including monoclonal antibodies, antibody fragments, glycoproteins, peptides, modified proteins and conjugates.

Biologics CMC development expertise

ICON supports the design and development of your candidate from selection to Proof-of-Concept through validation and product launch. We can assist in your CMC development strategy for biologics, scientific guidance, agency interactions and CMO selection, regulatory strategy and management. With our extensive workforce knowledge and experience in product development, we can also assist in the evaluation of the potential for in-licensing and out-licensing associated with due diligence activities.

Our approach is flexible and collaborative – from providing one-time technical consultancy to joining your project team for the design and implementation of client regulatory CMC strategy. Our independent and objective analysis ensures that your project meets the required technical and quality objectives and is delivered on time and within budget.

We work with clients to define the most streamlined CMC program for each product. Our drug development experience means we can quickly identify issues as they arise and keep the project on track. We have experience in the following areas:

CMC development strategy for biologics

• Technical due diligence (in/out licensing)
• Technical consultancy
• Selecting & managing the ‘best fit’ suppliers

Process Development & Manufacturing

• QbD strategy (Quality by Design) and development continuity planning
• Upstream & downstream process development
• Liquid fill finish & lyophilization development
• Technology transfer & manufacturing management
• Lean Six Sigma methodology & continuous improvement
• Troubleshooting & risk analysis

Analytical development

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

Process validation

• Process optimization and scale up
• Process understanding and DoE studies
• Scale down challenge studies
• Critical Quality Attribute assessment
• Design space definition
• Technical writing of CMC dossiers (e.g. US preIND/IND, NDA, 505b2, BLA, Biosimilars, ANDA, IMPD, EU MAA, Post approval supplements, CTD Module 3 and QOS, GMO risks dossier (EA))

Life cycle changes

• CMC change assessment (e.g. substantiality or not, amendments)
• Regulatory impact assessment for CMC changes
• Variations and IND updates strategy, writing and submission