Integrated CMC

 

Integrated Chemistry, Manufacturing and Control

Our truly Integrated Chemistry, Manufacturing and Control capabilities fully support drug substance and drug product development and GMP manufacturing from FIH to Phase III clinical development programmes on behalf of our partners around the world.

Our teams are composed of multi-disciplinary, industry-leading scientists who possess integrated knowledge of every step contained within CMC development activities, from laboratory to commercial scale for both API and drug product.

Straightforward, continuous processes from API to pre-clinical data and clinical supply enable end-to-end development of new chemical entities, without the need to align different providers. 

This allows time optimisation and risk mitigation for each single development project, in the capable hands of our expert project management professionals.

Our integrated CMC capabilities include:

  • API polymorph screening, salt-selection, co-crystals screening
  • API route scouting, process development and scale-up
  • API GMP manufacturing
  • Solid state characterisation
  • Pre-formulation 
  • Drug product formulation prototyping and development
  • Drug product process optimisation, scale-up and transfer to GMP production
  • Clinical manufacturing
  • Commercial manufacturing for small volume/niche product 
  • Analytical development and quality control
  • Project management, quality assurance, consultancy

Areas of Excellence

  • Superior expertise in both conventional and bio-enhanced oral formulations and inhalation development
  • Thought leadership in Accelerated Stability Assessment Programs (ASAP)

Integrated CMC: End-to-end development of New Chemical Entities

API
Pre-formulation
Drug Product
Synthetic route
Early formulation
Formulation design
Starting materials, reagents and intermediates control
Biopharmaceutics
Excipient compatibility
Reference materials
Manufacturability
API manufacturing
Drug product manufacturing
API Synthetic route
Pre-formulation Early formulation
Drug Product Formulation design
API Starting materials, reagents and intermediates control
Pre-formulation Biopharmaceutics
Drug Product Excipient compatibility
API Reference materials
Pre-formulation
Drug Product Manufacturability
API API manufacturing
Pre-formulation
Drug Product Drug product manufacturing

Contact us

Evotec

Business Development

T +44.(0)1235.86 15 61 F +44.(0)1235.86 31 39 vCard
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