Heraeus, Evonik collaborate on HPAPIs

Germany-based Evonik and Heraeus Precious Metals have announced that they are collaborating to expand their range of services for HPAPIs. They intend to build a fully integrated offering from the pre-clinical stage to commercial manufacturing, with streamlined transfer between small- and large-scale production between their respective sites.

Heraeus’s Pharmaceutical Ingredients business offers customised services for both earlier and later clinical phases and smaller to mid-volume HPAPI commercial products. It claims to be the world’s leading supplier of platinum-based HPAPIs.

The business offers development and manufacturing services for cancer therapy, focusing on HPAPIs and payloads including linkers and toxins for ADCs. Its range of services includes GMP for clinical trials, photochemistry in batch and continuous flow mode, high-containment systems for OELs of <10 ng/m³, advanced equipment and CMC documentation for global approval and regulatory support.

Meanwhile, Evonik’s Health Care business is one of the world’s largest pharmaceutical CDMOs, and one of the largest process developers and manufacturers of HPAPIs. At Tippecanoe, Indiana, it can manufacture six different HPAPIs in parallel and has a total capacity of 170 m³, while the Hanau facility has process and analytical laboratories to develop and optimize HPAPIs requiring containment down to an OEL of 5 ng/m³.