Containment & HPAPI
Highly potent API manufacturing.
World´s largest HPAPI process development and producer
One of the key challenges facing HPAPI manufacturers is safe operations with HPAPIs that have an extremely low occupational exposure limit (OEL).
Ingredients or intermediates of this kind require specialized containment to protect employees and the surrounding environment from exposure. This is far from straightforward – particularly when production levels can range from lab-size quantities to large-scale manufacturing projects.
As the world’s leading producer of HPAPI, Evonik has proactively addressed this crucial aspect of the manufacturing process. By implementing suitable primary containment measures, we ensure safe operations at all times, and at all production scales. As a result, we can work with HPAPI with an OEL as low as 0.1 µg/m³ – a real plus for many HPAPI applications in today’s pharmaceutical industry.
Highly Potent API (HPAPI)
World´s largest HPAPI capacity
Leading HPAPI producer for more than 20 years
Main site Tippecanoe Laboratories, Lafayette, IN, USA
From lab scale up to 8,000 l reactor volume
Total capacity: 170 m
OEL down to 0.1 μg / m
API for clinical and commercial supply
Global Top 3 API producer
FDA-inspected plants in Germany, US, China
Total cGMP reactor volume > 1000 m
Large-volume cGMP reactors up to 15,200 l
Development and manufacturing of very complex multi-step API
Controlled API / HPAPI
European and US-based production
US (DEA) and European controlled API
Conjugation of API (e. g. PEGylation)
Different conjugation technologies for API
Expertise in linker chemistry
Highly pure mPEGs and PEGylation particle design
Dedicated lab and experts
Development of crystallization, polymorph control, solid / liquid separation, drying, particle size control
Broad range of milling technologies and equipment
Spray drying expertise including non GMP commercial scale equipment