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API contract manufacturing organization - CMO services

Evonik is a preferred CMO Partner for APIs, HPAPIs, intermediates and products made by fermentation

The global network, process expertise and upscaling capabilities to support even the largest or most complex CMO API projects

When it comes to the process development and manufacturing of small molecule APIs and products made by fermentation, there are few CMOs in the world that can match Evonik’s size, scale and track record for performance. For more than 20 years, Evonik has served as a preferred global CMO partner to commercialize even the largest or most complex projects for API, HPAPI and advanced intermediates. Our CMO network of trusted sites across Europe, the U.S. and Asia are equipped with some of the most advanced capabilities in the CMO industry for the GMP manufacturing of APIs utilizing either batch or continuous processes. In addition to having one of the world’s largest and most versatile capacities for the lab, clinical and commercial-scale manufacturing of bulk or controlled APIs, we can bring together some of the pharmaceutical industry’s finest process engineers, chemists and technology specialists to establish project teams to efficiently co-ordinate upscaling stages to accelerate speed to market.

A Western-centered network of reliable CMO sites for an assurance of API quality and supply

Our global network of multi-purpose manufacturing sites across the U.S., Germany, France, Slovakia and China make us one of the world’s largest and most specialized CMOs for the supply of custom APIs and intermediates at any scale from grams to thousands of tons per year. For multi-step API projects including those that are highly potent or require the handling of controlled substances, our CMO services are arguably best-in-class. To address your company’s specific project needs, all of our CMO sites are equipped with one or more advanced technologies including high potency APIs, continuous processing, biocatalysis and catalysis, PEGs and mPEGs, chiral, carbohydrate and cryogenic chemistry and polymer APIs. In addition to APIs, we are also the world’s leading CMO for the commercialization and scale-up of advanced foods and other products made by microbial fermentation. Each of our CMO sites for API manufacturing has a strong regulatory record to help ensure consistently high levels of quality and supply security for our customer.

Evonik is a global CMO leader for API process development and upscaling

Due to our superior technological and research base, Evonik has the technical expertise to develop robust processes to ensure even highly complex APIs can be reliably scaled-up to help reduce clinical and commercial risk. In addition to a global team of several hundred in-house engineers and chemists that can support large investment projects, customers can also leverage the support of more than 25 lab groups for chemical CMO development that have helped bring dozens of APIs to market. In addition to our extensive batch and continuous processing capabilities, we have also established a comprehensive set of CMO services including route scouting and optimization, process development, analytical development. Furthermore, many of our manufacturing sites have highly specialized assets including flexible pilot plants for downstream processing, continuous processing and the production of mPEGs. To further support efficient upscaling to large-scale commercial manufacturing, a complete set of process engineering competencies are available including particle technologies, bioprocess technologies, reaction technologies and fluid processing.

A preferred CMO supply partner for the large-scale GMP production of your APIs and intermediates

A short review of our industry credentials will quickly identify how Evonik is strongly positioned to serve as a long-term CMO partner to address your large-scale GMP manufacturing requirements across a broad range of reaction types. We are not only one of the world’s top three largest CMOs for APIs and intermediates, but the industry’s largest HPAPI process developer and manufacturer with a total reactor capacity of 170 m3 and the ability to run up to seven different API steps in parallel. We also have the world’s largest cGMP capacity for cryogenic reactions, and more than 4000 m3 of fermentation capacity with more than 20 different enzyme types already used in commercial scale. This broad combination of technologies, technical expertise and large-scale GMP manufacturing capacity ensures we can serve as a reliable CMO partner for virtually any small molecule API, advanced intermediate or fermentation project.

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