The global network, process expertise and upscaling capabilities to support even the largest or most complex CDMO API projects
When it comes to the process development and manufacturing of small molecule APIs, there are few CDMOs in the world that can match Evonik’s size, scale, quality record and performance. We have served as a preferred global Contract Development & Manufacturing (CDMO) partner to develop, optimize and commercialize even the largest or most complex projects for API, HPAPI and advanced intermediates. Our wholly owned and operated cGMP sites across the U.s. and Germany with supporting sites in SLovakia, France, and China perform many complex processes to produce 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 bring together some of the pharmaceutical industry’s finest process engineers, chemists and technology specialists to establish project teams to efficiently upscale stages and accelerate our clients' speed to market.
A WESTERN-CENTERED NETWORK OF RELIABLE CDMO SITES FOR AN ASSURANCE OF API QUALITY AND SUPPLY
Our global network of multi-purpose manufacturing sites across the U.S. and Germany; with supporting sites in France, Slovakia and China, makes us one of the world’s largest and most specialized CDMOs for the commercial 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 services are fit for purpose and maintain excellent quality records. To address your company’s specific project needs, all of our facilities 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. 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.
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 and it will help you assess what you need for large or complex API projects – especially those focusing on large-scale manufacture of HPAPIs.
EVONIK IS A GLOBAL CDMO LEADER FOR API PROCESS DEVELOPMENT AND UPSCALING
Due to our superior technological and research base, Evonik has the expertise to develop robust processes to ensure even highly complex APIs can be reliably scaled-up to help reduce clinical and commercial supply 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 CDMO 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 CDMO services including route scouting and optimization, process development and analytical development. 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, biomanufacturing, reaction technologies and fluid processing.
A PREFERRED CDMO 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 CDMO 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 Contract Manufacturing Organizations 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, biopharmaceutical or fermentation processes.