INCOG BioPharma Services, an Indiana-based contract development and manufacturing organization (CDMO) has completed the construction of its cleanroom production area within the new 90,000ft2 biopharma manufacturing site.
The fill-finish organization will be a key partner to life sciences companies that outsource the manufacturing of innovative injectable therapies. The newly completed cleanroom area within the building will feature a multi-use aseptic filling line, including fully integrated isolator technology, that can process both bulk vials and ready-to-use (RTU) vials, syringes, and cartridges. In addition, INCOG plans to conduct formulation activities, inspection, labeling, and packaging services in its recently constructed manufacturing space.
INCOG partnered with AES Clean Technology (“AES”), a leading provider of cleanroom facilities supporting the biopharmaceutical industry. AES equipped the new state-of-the-art facility in Fishers with its modular cleanroom systems and high-performance HVAC technology to optimize environmental control. The recently installed cleanroom systems provide INCOG with the flexibility and customization for growth, including the ability to quickly triple its drug product manufacturing and handling capacity via future capital investment projects.
With both speed-to-market and impact on patients in mind, INCOG has utilized an integrated design-delivery approach throughout the project to design, install, and commission its cleanroom in record time. AES has helped drive the process toward successful commissioning and qualification at every step of the way.
Grant Merrill, Chief Executive Officer of AES Clean Technology commented, “We are proud to partner with INCOG and support their mission of creating a better path to market for life-saving drugs through the therapies that they manufacture inside our cleanroom facilities.”
INCOG’s Vice President of Operations, Alex Haig, who steered the project, said, “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. 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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