Containment and HPAPI

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


API Conjugation
  • 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


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Health Care Case Study

Case study: Development & implementation of a large-scale HPAPI manufacturing process

Case Study
HC Portfolio

Custom Manufacturing Organization for API, HPAPI and Intermediates