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●This modern CDMO site enhances GMP production of RESOMER® bioabsorbable polymers to meet global market demand
● Coordinated development with Evonik's biomaterial factory in Germany, dual source selection, and improved supply security
●● Further expansion of CMO services to provide customers with large-scale and commercial production of their excipients
●Evonik Industries has announced the successful commissioning of its advanced biomaterials plant in Birmingham, USA, to meet the global market demand for RESOMER® bioabsorbable polymers
.
The new factory covers an area of 2,800 square meters and has multiple clean rooms, reactors, professional purification and micronization systems and other supporting equipment
.
The contract R&D and manufacturing (CDMO) base has successfully passed the inspection of the US Food and Drug Administration (FDA) and relevant EU agencies, and can provide formulation development and GMP pharmaceutical services for a series of injectable drug products, as well as implantable medical devices.
Application development and mass production services
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Evonik has integrated the equipment and processes used at its two biomaterial plants in Birmingham, USA and Darmstadt, Germany, so that pharmaceutical and medical device customers can also benefit from a range of dual sourcing options
.
Dr.
Andreas Karau, Global Head of Biomaterials, Evonik's Healthcare business line, said: "Our state-of-the-art biomaterials factory has been commissioned in Birmingham, which means that in the supply of RESOMER® bioabsorbable polymers standard and customized products, medical Device and pharmaceutical customers gain greater flexibility regardless of any clinical or commercial scale
.
Mr.
John Daly, Plant Manager at Evonik's Birmingham Laboratory, said: "Birmingham is now a global centre of excellence for the design, development and supply of biomaterials
.
The Healthcare business line is part of Evonik's Nutrition and Consumer Chemicals business segment, serving more than 1,000 pharmaceutical, nutritional and medical device customers around the world
.
