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Evonik Qualifies Advanced Aseptic Filling Line

Expands Evonik’s range of CDMO services for pharma customers with complex, personalized or highly potent drugs.

Evonik, a global CDMO for advanced drug delivery, has announced the qualification of an advanced aseptic filling line for complex parenteral drug products at its FDA-inspected Birmingham facility in the U.S. State of Alabama.
 
Features and Capabilities
 
The VarioSys line, which was designed by Bausch+Ströbel, can aseptically fill powder, liquid, suspension or combination forms into vials in a range of clinical or commercial batch sizes.
 
The line features automated 100% weight verification to minimize product loss and optimize levels of quality and safety through improved dose accuracy. Also, the ability to efficiently interchange components or equipment makes it ideal for the high-yield manufacturing of products with complex filling processes, or the rapid conversion to a new formulation.
 
The versatility of the filling line makes it suitable for use with highly potent, personalized or sensitive drug products, as well as some specialized vaccines, which are often designed for the systemic or localized delivery of small molecules, peptides, proteins and nucleic acids.
 
“The ability to cost-effectively fill complex parenteral drug products in powder and other forms within an aseptic environment has been a major unmet need for pharmaceutical companies,” said Paul Spencer, head of pharma polymers and services at Evonik’s Health Care business line. “The qualification of this advanced, modular filling line at our Birmingham facility will further enhance our ability to serve as a preferred partner to pharmaceutical customers during the formulation development and cGMP manufacturing of their polymeric and lipid-based parenteral drug products.”
 
“Evonik has planned with great foresight, and with a clear and bold vision of the future, to support pharmaceutical companies in the production of their high-value medications with the highest possible process quality,” added Thomas Bühler sales group leader North America, Bausch+Ströbel. “From the outset, Evonik required a system with maximum flexibility to allow the processing of a broad array of active ingredients and packaging materials with little effort and in the shortest possible time.”

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