Evonik Commissions US Pharma Biomaterials Plant
Evonik has commissioned a new advanced biomaterials facility at its Birmingham, Alabama, US site, designed to support increasing global market demand for bioresorbable polymers with parenteral drug products and implantable medical devices.
With the inauguration of the new 2,800m2 facility, equipped with multiple cleanrooms, numerous reactors, specialized purification and micronization systems, along with other ancillary equipment, Evonik said it will be able provide contract manufacturing (CMO) services.
Together with an adjoining facility in Birmingham, the Essen-based group also will be able to leverage an integrated range of biomaterial services at a single US site to support projects from initial feasibility down to commercial production standard or custom products based on its Resomer-branded materials.
The adjacent CDMO site, already approved by the US Food and Drug Administration and EU health authorities, provides 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 said.
As the new Alabama plant uses the same type of equipment and processes as those utilized at Evonik’s other main biomaterials facility in Darmstadt, Germany, the group’s pharmaceutical and medical device customers will now have access to a range of dual-sourcing options.
Evonik’s Health Care business line, part of its Nutrition & Care segment, supplies more than 1,000 pharmaceutical, nutraceutical and medical device customers worldwide. In addition to bioresorbable polymers, the offerings include the Endexo-branded surface modification technologies and application technologies services.