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API contract manufacturing organization - Development & up-scaling

A leading CMO for process development and upscaling for more than two decades 

We can bring together the right manufacturing capabilities, processes expertise and track record to match your specific project needs

When it comes to the process development and upscaling of small molecule APIs, HPAPIs and intermediates, as well as the fermentation of other advanced materials, there are few CMOs that can match Evonik. As a global CMO partner with a broad, flexible technology portfolio and global network of trusted manufacturing sites, we are committed to minimize your project risk and optimize scale-up processes to ensure consistently high levels of quality. In particular, we excel in the development and upscaling of large or complex projects where chemical synthesis requires a flexible mix of advanced technologies to support multiple process steps. In addition to process development and the introduction of the product to its target manufacturing site, we can also help:

  • Optimize established processes

  • Troubleshoot new and existing processes

  • Co-ordinate Design of Experiments (DOE)

  • Conduct safety and hazard assessments

Furthermore, we can undertake route scouting for new processes and provide a range of project engineering and analytical method development services.

Efficient project management is the key for a CMO to ensure the successful development and upscaling of your API, HPAPI or intermediates

Evonik has more than 25 lab groups dedicated to our CMO activities. This large team of process technology, engineering and chemistry experts are situated across our global network of CMO sites. Additionally, we can leverage the competencies of other specialized R&D and engineering groups within Evonik to create additional value as required. Our experts can be efficiently aligned to form project teams matching your specific technology and scale-up requirements during any project stage from initial lab-scale during initial PR&D through to clinical supply and commercial launch. The project manager and supporting team will bring together decades of expertise across areas including:

  • PR&D

  • Quality assurance and control

  • cGMP and non-GMP manufacturing

  • Plant engineering

  • Environmental health and safety

Typically, they will be able to draw upon the experiences they have gained during equivalent projects with other customers to efficiently optimize your reaction process.

A range of CMO services available to optimize your technical package and ensure effective process transfer

A range of CMO services are available to reflect the development status of your project and the overall maturity and quality of the technical package. In addition to process technologies and analytical equipment used to cover the most common reaction types for small molecule APIs and intermediates, our process and analytical labs are also equipped with isolators and other containment equipment to handle highly potent APIs and ultra-HPAPIs with an OEL down to 0.05 μg/m³. We offer a complete set of process technologies including:

  • Continuous processing

  • Particle technologies

  • Bioprocess technologies

  • Environmental technologies

  • Fluid processing

  • Automation

With these and other flexible capabilities, together with the expertise of our teams, we can develop comprehensive processes that clearly define protocols, equipment, materials and analytical methods to best facilitate an effective transfer.

Our global network of cGMP labs and manufacturing facilities can address your pilot, small and medium-scale batch requirements

In addition to having the ability to cover most classical organic reactions types, our global network of sites ensure we are fully equipped to support a range more advanced reactions including:

  • Fermentation

  • Chiral resolution

  • Catalysis

  • Biocatalysis

  • Cryogenic reactions

  • Peptide coupling

  • Hydrogenations

Examples of our capabilities to support you during the initial stages of PR&D include:

  • Dedicated facilities in Germany and the U.S. for the pilot and small-scale manufacturing of APIs

  • A cGMP suite for the small-scale production of HPAPI and ultra-HPAPI

  • A dedicated kilolab for the custom synthesis of highly pure PEGs and mPEGs

For fermentation, we offer advanced capabilities including a flexible downsteam processing pilot plant. We are also accustomed to the development and installation of additional capabilities at our sites to support additional customer requirements. Contact us any time to discuss your individual requirements.

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