Germany-Based Evonik Opens Advanced Biomaterials Complex in Birmingham, Alabama
The expansion will also allow Evonik to provide contract manufacturing services to customers seeking to outsource production of their own proprietary biomaterials.
According to company officials, the new 30,000 square foot facility in Jefferson County is equipped with multiple clean rooms, numerous reactors, specialized purification and micronization systems and other ancillary equipment.
Together with an adjoining facility in Birmingham, Evonik said it 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, officials said.
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.”
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.”
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