Highly potent active pharmaceutical ingredients (HPAPI) represent an increasingly significant share of the pharmaceutical drug pipeline including anti-cancer treatments. 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 a HPAPI come and see us early on and learn more about our experience and commercial manufacturing capabilities.
DRAWING ON 20+ YEARS OF HPAPI EXPERIENCE TO DELIVER YOUR CLINICAL AND COMMERCIAL PRODUCTS
Evonik has been one of the world’s largest process developer and manufacturer of HPAPIs for more than 20 years. We have set industry standards through our broad technology portfolio, excellence in process engineering, and unrivaled safety standards. Many HPAPIs are synthesized through multiple process steps which require advanced technologies, such as peptide coupling, mPEG/PEGylation, continuous processing, chiral resolution, catalysis or biocatalysis, and cryogenic reactions. Our interdisciplinary team draws on strong technical competencies to develop effective risk control systems based on a comprehensive assessment of exposure hazards and other safety risks for each step of the chemical synthesis.
Case study: How Evonik successfully conducted an HPAPI pilot campaign
A new customer came to Evonik’s Health Care business with the task of developing the process chemistry and scaling up the production of an HPAPI to cGMP standards.
The goal was to set up a process suitable for commercial production within a time frame of less than 8 months at Evonik’s site in Tippecanoe in the U.S.
OUR TEAM OFFERS ONE OF THE LARGEST BATCH SIZES (> 400 kg) OF CONTRACT MANUFACTURED HPAPIS
Our Tippecanoe facility in Lafayette, Indiana, in the U.S. can run six different HPAPIs in parallel and has a total capacity of 170 m3. With containment capabilities down to an OEL of 0.1 μg/m3, the Tippecanoe site features numerous QC and process development lab support areas. As a multi-product facility, the main unit was designed to prevent cross-contamination of products and ensure worker safety. Our industrial hygienists, maintenance teams, quality assurance experts, operations teams and engineering and automation personnel have achieved an impeccable safety and containment record spanning 25 years of HPAPI manufacturing.
In our Hanau facility in Germany, we run process and analytical laboratories to develop and optimize HPAPIs requiring containment down to an OEL of 5ng/m3. Manufacturing of highly potent APIs is possible under GMP or non-GMP conditions.
Overall, Evonik covers scales from lab up to 7,600 l reactor volumes.
ENSURING YOUR HPAPI IS MANUFACTURED SAFELY AND SECURELY
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 the 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, are individually assigned. Our toxicologists and industrial hygiene specialists oversee our advanced cleaning methods and comprehensive waste treatment systems including on-site solids and liquids incineration. Tailored manufacturing equipment and robust analytical methods provide our customers with a global high potent network for drug substances.
OUR HPAPI SERVICES AND EXPERTISE
Custom drug substance services
- HPAPI development and cGMP lab scale manufacturing ( > 5 ng/m3)
- HPAPI production ( > 0.1μg/m3)
Custom drug product services
- Oral dosage forms (cGMP, > 1μg/m3)
- Parenteral formulations ( > 0.1μg/m3)
- Oral dosage form development ( > 0.1μg/m3)
- Complex organic reactions
- Asymmetric synthesis
- Transition metal catalysis and biocatalysis
- Cryogenic reactions (e.g. organometallic)
- Milling of highly potent APIs (slurry, pin, jet mill)
SCALABLE SOLUTIONS FOR HPAPI MANUFACTURING
We design chemical 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.
A strong partner for your HPAPI project
Moving your high potency APIs from lab to large scale takes qualified facilities and stringent compliance with regulatory and safety requirements. We handle it for you.
Are you looking for support to develop and manufacture an HPAPI? Let our highly skilled staff take you through development, validation and commercialization of your drug substance.
Dr. Ingo Klement together with our global team of experts is ready to answer your questions.
Additionally, please download our case study to learn more about our HPAPI capabilities at Evonik.