Are you thinking of outsourcing a large or specialized API project?
Contract manufacturing organizations (CMOs) provide companies with the peace-of-mind they need to work on challenging drug development and drug manufacturing projects. When you partner with a CMO you benefit from comprehensive services. Evonik is one of the world’s largest contract development and manufacturing organizations (CDMO). We have unique core competencies across chemistry, engineering and biotechnology and combine these with a proud record of performance for quality, supply security and sustainability.
Your preferred partner for the largest HPAPIS and most complex API projects
Over more than two decades we have worked with customers on innovator-focused HPAPI projects and complex API processes. Our established manufacturing network supplies APIs, HPAPIs and intermediates from clinical trial demands up to the largest commercial volumes. If you are looking for a reliable partner with high-quality production and a sustainable supply, we can help you – regardless of your project size or complexity.
When you partner with Evonik you benefit from:
- A leader in API contract manufacturing and process development
- Innovator-focused solutions
- Experience serving a broad client base including > 5 of the top 10 global pharma companies
- A strong foundation in synthesis of HPAPI and complex API at all scales
- A leader in emerging and complex technologies
- 6 FDA/EU approved commercial scale development and production sites across Europe, US and China
Whether you work on pharmaceuticals or are looking to outsource the commercialization of advanced food ingredients, we have the facilities and expertise you are looking for.
Choosing a CDMO for complex API chemistry
In the past 20 years, the structures of APIs have become increasingly complex as the demand for specialized or personalized therapeutics increases, and innovators search for new chemical modalities in drug discovery and design. The average number of steps required for the chemical synthesis of small molecule APIs has almost doubled in the last two decades.
Using classical chemistries to synthesize APIs of increasing complexity is often not feasible or desirable. Most small molecules in clinical development require multiple different advanced technologies for a single synthetic sequence. Examples of advanced technologies used to synthesize complex APIs include containment for high potency APIs, continuous processing, synthesis and conjugation with PEGs and mPEGs, carbohydrate chemistry, online monitoring by process analytical technologies (PAT), catalysis and catalyst recycling, biocatalysis, cryogenic chemistry, as well as chromatography
It is challenging for any single pharmaceutical company or CDMO to develop a portfolio of advanced technologies that can accommodate the needs of all process steps involved in the production of such complex APIs.
For APIs requiring very special technologies – complex API chemistry – Evonik has a broad portfolio of advanced technologies. Whether you require complex synthesis of more than eight steps or certain building blocks such as chirality, you can partner with us for expertise and reliability.
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.
A solution provider for innovator-focused HPAPIS
Highly potent active pharmaceutical ingredients (HPAPIs) are a good example of complex APIs that require a range of classical and advanced technologies to support their synthesis. Typically, HPAPI projects can have several process steps, with at least some of these steps requiring reaction types such as amide coupling, chiral resolution, catalysis, biocatalysis, or cryogenic chemistry. HPAPIs represent an increasingly significant share of the pharmaceutical drug pipeline – especially for anti-cancer treatments.
Evonik is the world’s largest custom contract manufacturing organization for high potency, anti-cancer and anti-infective APIs, with more than 20 years of expertise in this specialized area. Manufacturing highly potent APIs in large volumes requires extensive project experience with HPAPIs and a strong track record for audits and supply security. Only a few CMOs have the capabilities and experience to turn small-scale development lab quantities to large-scale commercial volumes with batch sizes of over 450 kg. When you plan to produce large volumes of an HPAPI come and see us early on and learn more about our experience and commercial manufacturing capabilities.
A western-centred global footprint for reliable; high-quality production and supply
Our six sites in Europe, the U.S. and China capacities from lab-scale through to small, medium or large-scale production.
- Tippecanoe, USA: Five small molecule plants including three for HPAPIs with total reactor capacity of 860 m3.
- Hanau, Germany: Multi-purpose cGMP site with 196 m3 capacity.
- Dossenheim, Germany: Three cGMP and non-GMP plants for API and intermediates.
- Fermas, Slovakia: Multi-purpose fermentation site.
- Ham, France: Multi-purpose cGMP site: 65 m3 capacity.
- Nanning, China: Three cGMP sites and four amino acid plants.
Your preferred CDMO for APIS and intermediates
Developing and manufacturing APIs and complex intermediates requires experience of advanced synthesis and process development. We offer customized chemical GMP synthesis for small molecule APIs from clinical trials to commercial supply. Late-phase clinical trials require a scalable process and our experts can advise you on scaling up and work together with you to design process and impurity control strategies
Integrated drug substance services to meet your development and manufacturing needs
Developing and manufacturing a drug requires a customizable approach because we know that each project is unique. Our fully integrated services offer you phase-appropriate support irrespective of project size:
- Analytical services
- Regulatory affairs services
- API process research & development services
- API clinical trial material supply services
- API commercial production services
- HPAPI product handling at large scale
- Particle engineering services
For drug delivery and products we offer:
- Solid form services
- Bioavailability Enhancement services
Trust our broad portfolio of advanced technologies from process development to commercial scale
Our highly differentiated portfolio of advanced technologies provides you with flexible solutions for even the most complex syntheses of specialized APIs, HPAPIs and intermediates.
We master key synthesis and purification technologies including:
- Transition metal catalysis: full service from catalyst screen and reaction kinetic models to scale-up and production. Catalyst recycling by organic solvent nanofiltration.
- Cryogenic chemistry: the world’s largest GMP capacity for cryogenic reactions.
- Amino acid chemistry: one of the world’s most trusted suppliers of pharmaceutical amino acids and dipeptides.
- Chromatography: small-scale GMP chromatography for ultra-HPAPI to commercial scale GMP chromatography.
- Biocatalysis: full service from screening to large-scale production.
- Chiral synthesis: decades of expertise in asymmetric synthesis and chiral resolution.
Alongside our core technological competencies, we also have highly differentiated skills including:
- Precious Metal Recovery
- Particle Design
- Crystal Engineering
- Chemistry in Water
- Sustainability assessments
Sustainability and quality
As manufacturing solution providers, sustainability is a key topic for the future of our business success and a healthy world. To assure accessibility of medicines for a growing world population we need to review and continuously improve the sustainability of manufacturing processes.
Balancing quality, environmental, cost and timeline aspects in pharmaceutical development programs is highly complex and it is becoming increasingly complex. At Evonik Heath Care we approach sustainability by a systematic and multifaceted approach during process development and product life cycle.
Evonik is included in the ESG Leaders Indexes. Ecovadis awarded Evonik platinum rating the second time in 2022. One of the novel technologies to improve sustainability of pharmaceutical processes is chemistry in water. Learn more about this here.
In terms of safety, Evonik’s Tippecanoe site in Lafayette, Indiana has passed seven consecutive FDA inspections from 2008 without a form 483.
Recognized in the CMO market; appreciated by our industry partners
Evonik Health Care has been recognized as a recipient of the 2022 CMO Leadership Awards. For the fifth consecutive year, companies participating in the Contract Manufacturing Quality Benchmarking survey by Life Science Leader and Industry Standard Research (ISR) voted for Evonik to earn awards across all six categories for its Capabilities, Compatibility, Expertise, Quality, Reliability and Service.
Best-in-class industrial capabilities and services
- Drug type - HPAPIs
- Drug substance services
- API manufacturing technologies
- Catalysis Special technologies
Deciding whether to outsource is never easy. We know that contract manufacturing is a busy market and it can be difficult to identify who is the best partner for your project.