A total capacity of 170 m³ with OEL down to 5 ng / m³
Highly potent active pharmaceutical ingredients (HPAPI) represent an increasingly significant share of the pharmaceutical drug pipeline including anti-cancer treatments. The small, medium or large-scale production of highly potent API at desired levels of quality consistency requires highly specialized process development and manufacturing capabilities, as well as a broad mix of associated advanced technologies. For more than 20 years, Evonik has been the world’s largest process developer and manufacturer of HPAPIs, with a total capacity of 170m³ and OEL down to 5 ng/m³. In addition to the development and implementation of highly potent API manufacturing processes for most classical organic reaction types, we excel at projects that require a flexible combination of advanced technologies including peptide coupling, chiral resolution, catalysis or biocatalysis, cryogenic reactions or large-scale fermentation.
From R&D to small and large-scale highly potent API manufacturing
Evonik can supply complex substances from grams to tons, with up to seven different HPAPI steps to be manufactured in parallel. Our Western-based sites for HPAPI manufacturing in the U.S. and Germany are harmonized to support the seamless process development and optimization of these complex drug substances, as well as their small, medium or large-scale production.
- Three of the five FDA-approved plants located at our Tippecanoe facility near Lafayette in the U.S. State of Indiana, specialize in the production of highly potent API down to OEL 0.1 µg/m³.
- Reactors range from lab-scale up to 8,000 liters in capacity.
- The Tippecanoe site also provides extensive cryogenic capacities (-80º C) as well as a broad range of services for analytical characterization.
- Our Hanau facility in Germany also provides process and analytical laboratories for the development and optimization of HPAPI or ultra-HPAPI down to 5 ng / m³.
HPAPI samples can be manufactured under either GMP or non-GMP conditions.
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A strong track record for quality and reliability
The production of highly potent API requires comprehensive management systems for their safe handling and containment to prevent risks such as occupational exposure or cross-contamination. Evonik has a strong history of quality management and regulatory excellence for HPAPI projects. Based upon
- he toxicity and OEL of the drug substance or its intermediates,
- the technologies required for each synthesis step,
- as well as other risk assessment and control strategies,
we will create development and scale-up processes that optimize safety and efficiency from lab-scale to full commercial production. In addition to the installation of isolators around process equipment and the use of advanced cleaning and trace analytical testing methods, we seek to further minimize risk with the inclusion of highly skilled experts in toxicology, industrial hygiene and hazard reduction on each project team.
Formulation development and production of high potency drug products
If you are not only seeking a partner for the contract manufacturing of your highly potent API, but also the formulation development and manufacturing of your complex drug product, Evonik can help. Our formulation and application labs in the U.S. and Europe are licensed to handle controlled substances (II-V) and HPAPIs, with extensive expertise in oral modified release, oral bioavailability enhancement and parenteral extended release. A modern facility in Germany can support the cGMP production of oral solid dosage form drug products with high potency API down to an OEL of 5 ng/m³. In the U.S., we also support customers in the aseptic cGMP production and vial filling of specialized parenteral drug products in powder, liquid or suspension form.