Specialty chemicals company, Evonik, has successfully commissioned an advanced biomaterials facility in Birmingham, USA.
The new facility will help Evonik to cope with the increasing global market demand for the use of Resomer bioresorbable polymers with parenteral drug products and implantable medical devices,.
The building is 2,800 square meters and comprises of multiple cleanrooms, numerous reactors, specialised purification and micronisation systems and other ancillary equipment. The site has been successfully inspected by US-FDA and EU health authorities, and is able to offer a range of formulation development and GMP manufacturing services for parenteral drug products, and application development and scale-up services for implantable medical devices.
Following the commissioning of this facility, Evonik will now be able to begin to provide contract manufacturing (CMO) services to customers who are seeking to outsource the production of their own proprietary excipients. Additionally, 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 harmonisation of the equipment and processes utilised at both Birmingham and its other main biomaterials facility in Darmstadt, Germany, will hopefully mean that pharmaceutical and medical device customers can benefit from a range of dual-sourcing options.
Dr. Andreas Karau, global head of biomaterials for Evonik’s healthcare 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, added: “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.”