API Process Development & Manufacturing

Evotec offers a comprehensive range of API capabilities, encompassing process chemistry, analytical, and manufacturing operations. With over 25 years of experience in the development and manufacturing of small molecule APIs, we have established ourselves as a leader in the field. In addition to offering integrated process R&D and analytical development services using state-of-the-art laboratory facilities and equipment, Evotec supplies APIs for preclinical development, non-clinical use, clinical trials, and small-scale commercial supply.

At Evotec, our chemistry teams and in-house Material Science experts work hand in hand on your project. Together, they conduct salt and co-crystal screens, polymorph studies, and utilize a wide range of crystallization technologies to develop and finetune scalable crystallization and drying processes.

To ensure compliance with cGMP standards and provide support for customer audits and regulatory inspections, we have an independent Quality Assurance unit that oversees all API activities. Their role is to uphold cGMP compliance and ensure the highest level of quality in our products and services.

Evotec provides its partners with exceptional API chemical development and manufacturing services, seamlessly integrated into a comprehensive research and development platform. Our chemistry, analytical, and manufacturing operations are co-located at facilities in Abingdon, UK, and Verona, Italy. Moreover, Evotec boasts a state-of-the-art cell factory in Modena, Italy, equipped to handle all stages of ATMP manufacturing, from development to production.

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Overview of Evotec's API Capabilities

Our FDA, MHRA, and AIFA approved cGMP Kilolabs, pilot plants and plants provide high flexibility to manufacture a wide range of APIs, including potent and controlled substances, at various scales, with vessel volumes ranging from 20L to 1,600L. Our production teams possess extensive experience in successfully delivering API manufacturing projects for preclinical, clinical, and commercial stages, working closely with our integrated process research and analytical development teams.

Evotec's API teams play a vital role in successfully delivering INDiGO, Evotec's accelerated IND and CTA submission process, working diligently to supply fit-for-purpose API materials within the tightest timelines to enable the conduct of pivotal studies required for the compilation of IND and CTA dossiers.

For later phase development, API process optimization, characterization and validation is supported by highly experienced scientists who possess specific expertise in risk-based methodologies and Quality by Design to establish critical process parameters and ensure process robustness.

The solid form matters!

The Material Science group combines their integrated expertise and facilities in solid state chemistry and physical properties, ensuring that the same team oversees the project from API development to the final drug product manufacture. The knowledge transfer from API to drug product manufacturing plays a vital role in determining the critical quality attributes and the selection of the ultimate fit-for-purpose formulation.

Analytical Support

Analytical teams support all phases of development with capabilities in method development, phase appropriate validation, informal and full ICH stability studies.  

Evotec specializes in chiral HPLC method development with more than 30 years’ experience in this area. All analytical processes are undertaken with data integrity assurance and have regulatory approval.

cGMP Manufacturing

At our sites in Verona, Italy and Abingdon, UK manufacturing is performed in fixed vessels with capacities ranging from 20L to 1,600L. Our operations adhere to full cGMP standards, approved by the FDA. We hold the necessary licenses from MHRA and AIFA. 

At our Abingdon site, in addition to the manufacture of investigational APIs, we also specialize in low volume commercial manufacturing typically for rare diseases indications and orphan drugs.

Medium Scale Oligonucleotides Manufacture Capabilities

A Cytiva ÄKTA OligosyntTM synthesizer (the first of its kind that was installed in Europe) is available at our Evotec site in Verona. This state-of-the-art equipment enables the synthesis of complex modified oligonucleotides (ASOs, siRNAs, etc) on a scale from 0.5g to 50g (up to 12 millimoles) to support the initial preclinical development studies. Coupled with the ÄKTA Flux 6 and ÄKTA Pure 150, this oligonucleotide synthesizer completes our fully integrated Oligo R&D suite at the Evotec Campus Levi-Montalcini in Verona. Both our Verona and Toulouse sites are equipped to support drug discovery programs in the field of RNA therapeutics with the synthesis of oligonucleotides on a research scale. Evotec is now able to also support the preclinical and clinical development studies with a comprehensive set of analytical and bioanalytical capabilities for this modality.

Quality Assurance

Our independent Quality Assurance unit oversees API activities to ensure cGMP compliance and provide both customer audits and regulatory inspections support.  Evotec works with a global network of approved raw material suppliers that provide highly specified starting material for pharmaceutical development.

Regulatory Affairs

Evotec offers full Non-Clinical, Quality (Chemistry Manufacturing & Controls) and Clinical Regulatory support with a dedicated team of highly experienced Global Regulatory Affairs professionals. This support can be offered for all API Development and Commercial projects.

API Capabilities Summary

Chemical Development

  • Route scouting, IP generation, cost of goods analysis 
  • Phase appropriate process development, process safety, process design and optimization
  • Large-scale chromatography to cGMP 
  • Late phase development, CPP studies, impurity purging, process characterization and validation readiness
  • Ongoing process verification and continuous process improvement
  • Integrated salt and co-crystal screens, polymorph studies, crystallization and drying technologies 
  • Genotoxicity and Nitrosamine risk assessments and control strategies

Analytical

  • Method development for raw materials, intermediates and API’s 
  • Analysis of non-chromophoric 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

  • 20L, 50L, 100L glass reactors
  • 150L, 300L, 1,000L Glass Lined Mild Steel reactors
  • 400L, 1,000L, 1600L Hastelloy reactors
  • 400L cryogenic unit to -80°C; Hydrogenation up to 1,600L at up to 6 Barg 
  • Enclosed filter dryer systems and dedicated isolation suites 
  • Handling high potent compounds with OEL ≥ 0.5 µg/m3
  • FDA approved, MHRA and AIFA licensed

APIs Covering All Development Phases & Commercial Production

API Process Development Manufacturing Extensive on line Chemistry Resources
Jerome Dauvergne

Jerome Dauvergne

EVP API Chemistry, Process Development & Manufacturing

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Evotec has the right technologies & disease understanding to meet our partners' evolving needs: a comprehensive disease knowledge at the molecular level, cutting-edge technologies & platforms to translate this expertise into effective precision medicines.