This FAQ explains how aseptic processing, contamination control, and validation protect patients amid sterile injectable failures.
|Articles|April 7, 2022
INCOG Biopharma Completes Construction of Cleanroom Production Area
Author(s)BioPharm International Editors
INCOG Biopharma has completed the construction of its cleanroom production area, marking a milestone in the completion of an overall $100 million investment in a new facility.
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INCOG Biopharma, a contract development and manufacturing organization (CDMO), has successfully completed the construction of a new cleanroom production area within its new 90,000-sq.-ft.biopharma manufacturing site. The completion of this construction marks a milestone in the company’s $100 million investment in a new facility and goals to ready current good manufacturing practice (CGMP) manufacturing capabilities for injectable drug product capacity.
The new cleanroom production area will feature a multi-use aseptic filling line with integrated isolator technology, capable of processing both bulk vials and ready-to-use vials, syringes, and cartridges. The cleanroom space will also be used for formulation activities, inspection, labeling, and packaging services. The cleanroom project, completed in collaboration with AES Clean Technology, will enable INCOG to greatly increase its drug product manufacturing and handling capacity as well as provide flexibility and customization for growth.
“I’m thankful for our partners at AES, Shiel Sexton, Javan Engineering, OPTIMA Pharma, and extended teams. INCOG is now even closer to opening our doors to advance therapies into the hands of patients and providers,” said Alex Haig, INCOG’s vice president of operations, in a press release. “The completion of the cleanroom space means we are ready to install our OPTIMA filling line and maintain our target to be CGMP ready by Q3 2022. With growing demand for injectables, our team is well positioned and ready to help alleviate capacity constraints in the global markets.”
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