Evonik and Heraeus cooperate to expand the range of services for highly potent active pharmaceutical ingredients

Evonik and Heraeus cooperate to expand the range of services for highly potent active pharmaceutical ingredients

Evonik specializes in mid- to large-scale, later clinical phase HPAPIs

  • By ICN Bureau | July 13, 2023

Evonik and Heraeus Precious Metals are collaborating to expand both companies’ range of services for highly potent active pharmaceutical ingredients (HPAPIs). The cooperative effort leverages the specific HPAPI competencies of both companies and provides customers with a fully integrated offering from the pre-clinical stage to commercial manufacturing. Customers will benefit from a streamlined transfer between small and large-scale production between the two companies which is based on an understanding of each other’s capabilities and assets, as well as the proximity of the Hanau manufacturing sites.

“As one of the earliest adopters of large-scale HPAPI production, our offering is perfectly complemented by that of Heraeus. This alliance benefits clients needing to develop and launch HPAPIs safely and quickly,” said Stefan Randl, head of Evonik’s Drug Substance product line.

Evonik’s Health Care business is one of the world’s leading CDMOs (Contract Development and Manufacturing Organizations) for active pharmaceutical ingredients (APIs) and intermediates, representing a key growth business for Evonik. It is part of the company’s life sciences division Nutrition & Care. The partnership with Heraeus Precious Metals builds on the company’s track record of delivering complex APIs to meet the clinical and commercial supply needs of biotech and large pharma customers around the world.

The Pharmaceutical Ingredients business at Heraeus Precious Metals offers customized solutions for both earlier and later clinical phases and smaller to mid-volume HPAPI commercial products in the marketplace.

“The supplementary approach with Evonik is thus a natural fit for Heraeus Precious Metals as it allows a smooth upscaling of small- and medium-scale projects that require larger scale commercial production at a later stage,” emphasized Dr. Marcus Hannakam, executive vice president business line Pharmaceutical Ingredients.

Extensive expertise as established service provider and world’s leading supplier of platinum-based HPAPIs

Heraeus Precious Metals’ Pharmaceutical Ingredients CDMO covers a full range of development and manufacturing services for cancer therapy, focusing on producing highly potent small molecules (HPAPIs), such as payloads including linkers and toxins for Antibody-Drug Conjugates (ADCs). The company is the leading supplier of platinum HPAPIs worldwide.

The range of services includes development and manufacturing under GMP for clinical trials, photochemistry in batch and continuous flow mode, high-containment systems for OELs (Occupational Exposure Limits) < 10 ng/m3, state-of-the-art equipment, CMC documentation for global approval and regulatory support. The Pharmaceutical Ingredients’ project teams can thus offer maximum flexibility, short lead times to execution and a customized approach for each customer.

With over 35 years of experience delivering active ingredients for oncology to its customers and operating exclusively out of Hanau, Germany, Heraeus Precious Metals’ Pharmaceutical Ingredients Business Line is a reliable and sought-after CDMO. With a proven track record in taking pre-clinical projects to registration, the company, additionally, has comprehensive know-how for process optimization.


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