INCOG BioPharma Services has announced that its sterile injectable manufacturing facility has received approval from the US Food and Drug Administration (FDA) to produce a commercially approved drug product.

The regulatory approval for its customers 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 aseptic 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," Humbert said.

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 through to commercialization," said Alex Haig, VP of Operations at INCOG.

"We value creating long-term relationships with our clients, to accelerate their innovative therapies to the patients that need them," Haig stated.

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," he added.