A LEADING CDMO FOR PHARMACEUTICAL PROCESS DEVELOPMENT AND UPSCALING 

ARE YOU LOOKING FOR A PARTNER WITH THE RIGHT MANUFACTURING CAPABILITIES, PROCESS EXPERTISE AND TRACK RECORD TO MATCH YOUR PRODUCT NEEDS?

A successful development and optimization program relies on close collaboration between you – our customer – and us at the developing site, alongside the application of key competencies. When it comes to the process development and upscaling of small molecule APIs, HPAPIs and intermediates, 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. 

OUR FLEXIBLE MIX OF ADVANCED TECHNOLOGIES CAN SUPPORT MULTIPLE PROCESS STEPS

If you are planning to develop and upscale large or complex projects, talk to us! We excel in chemical syntheses that require multiple process steps and have the technologies and expertise to make your project a success. 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. 

ROUTE SCOUTING FOR SUCCESSFUL PROCESS DEVELOPMENT

To develop a successful process, the requirements of both a product and its manufacturing needs must be met. We know that each route scouting and process development is unique in nature, but we recognize that some core characteristics are key:  

  • Broad expertise in different scientific fields – this ensures the best route selection and subsequent development from a quality and manufacturability perspective
  • Preventive measures – alternative routes to ensure successful development
  • Analysis of process requirements – from product as well as manufacturing site

Successful route scouting equips you with a viable synthetic pathway for further development and optimization.

Our development and optimization program consists of the following activities:

  • Confirmation of overall process feasibility and yields
  • Experiments to support fit to equipment and scale-up including
    • Confirmation of solvent volumes
    • Mixing studies
    • Production unit operation
    • Holding times
    • Cleaning and solubility testing
    • Filtration evaluation
    • MOC compatibility
  • Identification of impurities during synthesis steps and in final products

SAFETY ASSESSMENTS OF PRODUCT AND INTERMEDIATES AND ANALYTICAL DEVELOPMENT 

Evonik performs safety assessments of the product and the intermediates per internal safety requirements. This includes toxicological reviews including an OEL assessment and safety risk analysis for use within Evonik.

Close collaboration between process and analytical development is key to foster a highly successful program. Route scouting and process development activities are performed hand-in-hand with analytical development to ensure process understanding, developmental troubleshooting and state-of-the-art method development.

We carry out routine analytical techniques:

  • Liquid and gas chromatography
  • Titrations
  • Digestions

And a range of more specialized analytical techniques that are available on-site within Evonik:

  • NMR
  • GC&LC/MS
  • ICP-OES/MS

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:

  • 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.

Why are advanced technologies increasingly important for complex small molecule synthesis? In this whitepaper we outline what the growth in technology platforms used in chemical synthesis means for small, medium and large pharma companies.

Selecting a CMO partner is increasingly determined by the size, strength and flexibility of their advanced technology portfolio. This whitepaper will help you assess what you need for large or complex API projects – especially those focusing on large-scale manufacture of HPAPIs.

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:

  • Chiral resolution
  • Catalysis
  • Biocatalysis
  • Cryogenic reactions
  • Peptide coupling
  • Hydrogenations
  • Complex Processing
  • Chemistry in Water and Sustainability Assessments

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

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.

EFFICIENT PROJECT MANAGEMENT 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 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

To partner with a reliable and flexible expert on your process development and upscaling project, get in touch with us for more information: healthcare@evonik.com 

Looking for information compiled in one document? Our brochures offer an overview of relevant details in just a few pages.

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