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. Recently, we have expanded our services to include larger scale custom manufacturing of cGMP intermediates and cosmetic ingredients. In addition to offering integrated process research and development 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, Verona, Italy, and Halle, Germany. 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.

Our FDA, MHRA, AIFA, and BfArM approved cGMP labs, 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 20 to 4,400 L. 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 Material Sciences 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 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 30 years’ experience in this area. All analytical processes are undertaken with data integrity assurance and have regulatory approval.

At our sites in Verona, Italy and Abingdon, UK manufacturing is performed in fixed vessels with capacities ranging from 20 to 1,600 L. Our operations adhere to full cGMP standards, approved by the FDA, and 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 of niche products for rare diseases indications, orphan drugs, and launch stocks.

In Halle, Germany, our production capabilities span from grams to metric tons. Our site is EU-cGMP certified and offers a highly flexible drug substance manufacturing facility covering over 5,000 square meters. We have a wide range of reactors, from 100 to 4,400 L, with a total capacity exceeding 30 m³. The Halle plant can currently handle cGMP production of up to 50 kg batches for API and 500 kg batches for intermediates. We offer our partners highly flexible product lifecycle management strategies, particularly well-suited for commercial manufacturing of niche products for rare diseases indications and orphan drugs.

A Cytiva ÄKTA Oligosynt^TM 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 0.5 to 50 g (up to 12 millimoles) to support the initial preclinical development studies. Coupled with the ÄKTA Flux 6 and ÄKTA Pure 150, this oligonucleotide synthesizer has completed our fully integrated Oligo R&D suite at the Evotec Campus Levi-Montalcini in Verona. Both the Verona and Toulouse Evotec 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.

The 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.

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.

• 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

• 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

• 20 L, 50 L, 100 L glass reactors
• 25 L, 100 L, 300 L, 500 L, 800 L, 1,000 L, 1,200 L, 2,000 L, 3,000 L Glass Lined Mild Steel reactors
• 500 L, 4,400 L Stainless Steel reactors
• 400 L, 1600 L, 2,000 L Hastelloy reactors
• 500 L Zirconium reactor
• 100 L, 400 L, 500 L, 1,200 L cryogenic units to -80°C; Hydrogenation up to 1,600 L at up to 10 Bar 
• Enclosed filter dryer systems and dedicated isolation suites 
• Handling high potent compounds with OEL ≥ 0.5 µg/m³ 
• FDA approved, MHRA, AIFA and BfArM licensed