13 July 2023 | Thursday | News
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.
Manufacturing large volumes of HPAPIs requires years of experience
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, safety knowledge, systems and supply security.
Evonik has been one of the world’s largest process developers and manufacturers of HPAPIs for more than 20 years. The company has set industry standards through its broad technology portfolio, excellence in process engineering and unrivalled safety standards. The Evonik laboratories in Tippecanoe, Indiana in the U.S. can manufacture six different HPAPIs in parallel and has a total capacity of 170 m3. Evonik’s facility in Hanau has process and analytical laboratories to develop and optimize HPAPIs requiring containment down to an OEL of 5 ng/m3.
To address the specific needs of large or complex projects, Evonik has established a broad portfolio of differentiating technologies which can be combined to support multi-step API and HPAPI synthesis. In addition to superior technological expertise and an integrated portfolio of services, customers are also attracted by Evonik’s reliability and commitment to sustainability.