Evonik commissions advanced biomaterials production facility for pharmaceutical and medical applications in Birmingham, Alabama

• Modern CDMO site expands GMP capacity of RESOMER® bioresorbable polymers to meet global demand
• Harmonization with Evonik’s German biomaterials facility creates dual-sourcing options for improved supply security
• Widens range of CMO services for the scale-up and commercial manufacturing of customer’s own excipients

Evonik today announced the successful commissioning of an advanced biomaterials facility in Birmingham, USA that will support the increasing global market demand for the use of RESOMER® bioresorbable polymers with parenteral drug products and implantable medical devices. With this expansion, Evonik will also begin to provide contract manufacturing (CMO) services to customers seeking to outsource the production of their own proprietary excipients to an industry leader.

The new 2,800 square meter facility is equipped with multiple cleanrooms, numerous reactors, specialized purification and micronization systems and other ancillary equipment. Together with an adjoining facility in Birmingham, Evonik can now provide an integrated range of biomaterial services at a single U.S. site to support projects from initial feasibility through to the commercial production of RESOMER® standard or custom products.

The adjacent CDMO site, which has been successfully inspected by US-FDA and EU health authorities, also offers a range of formulation development and GMP manufacturing services for parenteral drug products, and application development and scale-up services for implantable medical devices.

Because Evonik has harmonized the equipment and processes utilized at both Birmingham and its other main biomaterials facility in Darmstadt, Germany, pharmaceutical and medical device customers can also benefit from a range of dual-sourcing options.

Dr. Andreas Karau, Global Head of Biomaterials for Evonik’s Health Care business line said: “With the commissioning of our new state-of-the-art biomaterials facility in Birmingham, medical device and pharmaceutical customers have even more flexibility in the supply of standard or custom RESOMER® bioresorbable polymers at virtually any clinical or commercial scale. We can also now offer an expanded range of CMO services to support customers in the scale-up and commercial supply of their own proprietary biomaterials and other excipients.”

Mr. John Daly, Site Manager of Evonik Birmingham Laboratories, said: “Birmingham is now a global centre of excellence for the design, development and supply of biomaterials. Regardless of the tightness of a customer’s product specifications or batch volume requirements, we have the technical expertise, operational flexibility, and regulatory track record to deliver the highest levels of quality and supply security.”

The Health Care business line, which is part of the Nutrition & Care segment of Evonik, serves more than 1,000 pharmaceutical, nutraceutical and medical device customers worldwide. Its biomaterials portfolio of RESOMER® bioresorbable polymers, Endexo® surface modification technologies and application technologies services are a core element of the Health & Care growth engine, which helps drive Evonik’s profitable and balanced growth.