CMC Development – Biologics

Biologics CMC Development Services

The CMC experts at Aptiv Solutions provide a comprehensive, integrated CMC development service with a global perspective for your biologics products.

With 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 resource to manage the implementation.

Our CMC biologics experts have worked with a wide range of recombinant products including monoclonal antibodies, antibody fragments, glycoproteins, modified proteins and conjugates.

Biologics CMC Development Expertise

Aptiv Solutions can support the design and development of your candidate from selection through Proof-of-Concept to validation and product launch. We can assist in your CMC development strategy for biologics, scientific guidance, and CMO selection and management. With our knowledge and experience of product development, we can also assist in the evaluation of the potential for in-licensing and out-licensing.

Our approach as a nonclinical CRO is flexible and collaborative – from providing one-time technical consultancy to joining your project team for the design and implementation of your entire 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
  • Stability testing
  • 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