INCOG BioPharma Services’ sterile injectable manufacturing facility has received approval from the U.S. Food and Drug Administration (FDA) to produce a commercially approved drug product.
 
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). Furthermore, for the third year in a row, INCOG received the Best Places to Work award from the Indiana Chamber of Commerce.