Contract Pharma Staff05.13.20
Evonik has commissioned an advanced biomaterials facility in Birmingham, AL to support increasing global market demand for the use of RESOMER bioresorbable polymers with parenteral drug products and implantable medical devices. This expansion will also begin to provide contract manufacturing services to customers looking to outsource the production of their own proprietary excipients.
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 a 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, 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.
Evonik has harmonized the equipment and processes used at both Birmingham and its other main biomaterials facility in Darmstadt, Germany, so that customers can 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.”
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 a 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, 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.
Evonik has harmonized the equipment and processes used at both Birmingham and its other main biomaterials facility in Darmstadt, Germany, so that customers can 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.”
