Achieves FDA Approval for Sterile Injectable Drug Product Manufacturing

 FISHERS, Ind, April 30, 2024 /PRNewswire/ -- INCOG BioPharma Services proudly announces that its sterile injectable manufacturing facility has received approval from the U.S. Food and Drug Administration (FDA) to produce a commercially approved drug product. The regulatory approval for its customer signifies a significant milestone for INCOG, as it positions itself as an emerging leader in the biopharmaceutical contract manufacturing industry.

The FDA approval comes after a rigorous inspection of INCOG's facility and quality systems, during which INCOG demonstrated compliance with FDA requirements for aseptic manufacturing. Notably, the inspection resulted in zero Form 483 observations, underscoring the company's commitment to excellence in quality systems and sterile manufacturing practices.

"We are thrilled to receive our initial FDA approval," said JR Humbert, VP of Quality for INCOG. "This remarkable achievement is a testament to the incredible team we have put together and our dedication to quality as a foundational element of our mission to be a best-in-class CDMO."

The company is currently expanding to add 100 million units of pre-filled syringe and cartridge capacity in 2025. The company's second barrier isolator filling line is scheduled for delivery in October 2024, with GMP readiness targeted for Q2 2025. This expansion brings the site's total capacity to approximately 140 million units per year and provides a clear path for additional commercial drug production at the facility.

"Our vision has always been to support customers from clinical stages all the way through to commercialization," said Tedd Green, COO and co-founder at INCOG. "We value creating long-term relationships with our clients, with the goal of accelerating their innovative therapies to the patients that need them."

In addition to the FDA approval, INCOG's facility was recently recognized as a finalist in the Facility of the Year Awards by the International Society for Pharmaceutical Engineering (ISPE). This recognition reflects the company's innovative approach to facility design and manufacturing processes, setting a benchmark for excellence in the industry.

Furthermore, for the third year in a row, INCOG received the Best Places to Work award from the Indiana Chamber of Commerce, which recognizes companies committed to fostering a positive work environment and supporting employee growth and satisfaction.

"We are proud of the recognition we have received for our commitment to excellence, both in our manufacturing facility and as an employer," said Tedd Green, COO and co-founder at INCOG. "These accolades reinforce our dedication to delivering high-quality products and creating a positive workplace culture."

About INCOG BioPharma Services: INCOG has been designed and built from decades of experience with a clear purpose: to deliver better CDMO services in the injectable drug product space. With our dedicated team, best-in-class processes, and state-of-the-art equipment, we provide meaningful results and stand-out customer experiences. We are here to strive for the best – for our team and our customers. We are ALL IN with you from the moment we start work on your project. We go above and beyond to understand your requirements, meet your needs, and foster a truly collaborative partnership.

Founded in June 2020 by a team of industry veterans, INCOG BioPharma Services offers manufacturing services to both early-phase and late-phase biopharmaceutical companies. The company's service offering includes filling drug products into vials, syringes, and cartridges. INCOG also offers support services, including formulation scale-up, analytical development, stability testing and storage, and auto-injector device assembly.

For additional information about INCOG BioPharma Services please contact us at info@incogbiopharmaservices.com

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SOURCE INCOG BioPharma