API capabilities

 Evotec’s Active Pharmaceutical Ingredient (API) Capabilities

Evotec’s comprehensive API services consist of chemistry, analytical and manufacturing operations that are co-located at sites in Abingdon, UK, and Verona, Italy, with more than 25 years’ experience of development and manufacturing small molecule API’s.  Alongside integrated process research and analytical development, Evotec supplies API’s for use in pre-clinical development, non-clinical use, clinical trials and small scale commercial supply. 

Overview of Evotec’s API Capabilities 

 

Evotec’s API teams are a critical part of INDiGO, Evotec’s accelerated IND submission process, working to supply API’s as fast as possible into pivotal studies required for IND dossiers.  For later phase development, API process validation is supported by highly experienced scientists with specific expertise in risk based approaches to establish critical process parameters and robust processes.  

The Evotec chemistry teams work closely with the in house Materials Science group on salt screens, polymorph studies and a full range of crystallisation technologies.

Analytical teams support all phases of development with capabilities in method development, phase appropriate validation, informal and full ICH stability studies.  Evotec specialises in chiral HPLC method development with more than 25 years’ experience in this sphere.  All analytical processes are undertaken with data integrity assurance and have regulatory approval.  

Manufacturing is performed in fixed vessels ranging from 100 L to 1600 L, operating to full GMP with FDA approval and the relevant MHRA and AIFA licences.  Low volume commercial manufacturing is undertaken for rare diseases, orphan drugs, niche products and launch stocks.  

Evotec works with a global network of approved raw material suppliers that provide highly specified starting material for pharmaceutical development.  

The independent Quality Assurance unit oversees API activities to ensure GMP compliance and provide both customer and regulatory audit support.  Evotec also has a long established third party relationships that can bring specialist advice on regulatory aspects.

API capabilities summary

Chemical Development

  • Route scouting, cost of goods analysis
  • Phase appropriate process development
  • Large-scale chromatography to GMP
  • Late phase development, CPP studies, impurity purging, validation readiness
  • Integrated salt screens, polymorph studies, crystallisation technologies
  • Genotoxicity and Nitrosamine risk assessments and control strategies

Analytical 

  • Method development for raw materials, intermediates and API’s
  • Analysis of non-chromaphoric materials using non-UV detection
  • Quality control, reaction monitoring, cleaning verification
  • Method qualification, limited validation, full ICH validation
  • Informal and formal stability to full ICH studies
  • Full data integrity compliance

Manufacturing

  • 20 L, 100 L, 300 L and 1000 L glass lined steel reactors
  • 400 L, 1600 L Hastalloy reactors
  • 400 L cryogenic unit to -80°C; Hydrogenation up to 1600 L at 6 Bar
  • Enclosed filter dryer systems and dedicated isolation suites
  • Handling high potent compounds with OEL = 0.5 µ/m3
  • FDA approved, MHRA and AIFA licensed

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