INCOG BioPharma Services, a leading contract development and manufacturing organization (CDMO) specializing in sterile injectable biopharmaceuticals, has unveiled ambitious expansion plans for 2025, building upon significant achievements from the past year.
Strategic Facility Expansion
Last September, INCOG broke ground on a second building at its Fishers, Indiana campus. The 113,000-square-foot facility will be connected to the current manufacturing site and is designed to significantly enhance the company's capabilities. This expansion will enable INCOG to provide comprehensive device assembly services for autoinjectors, pens, wearable injectors, and syringe accessorizing, along with new labeling and final packaging capabilities.
"This investment, coupled with expanding the facility and commissioning automated device assembly and packaging lines, reinforces our commitment to providing end-to-end solutions that meet the evolving needs of our clients," said Cory Lewis, CEO and President of INCOG.
Advanced Filling Capabilities
A cornerstone of the expansion is the installation of a high-speed Optima syringe and cartridge filling line, which was delivered in November 2024. Currently being prepared for qualification, this advanced system will add 100 million units of syringe and cartridge capacity annually and is expected to be GMP-ready by September 2025.
"Our new high-speed Optima filling line represents a significant step forward for INCOG, allowing us to efficiently fill both syringes and cartridges for large-scale commercial projects," Lewis explained.
Workforce Growth and Economic Impact
The 2025 expansion strategy includes a substantial hiring initiative that will increase INCOG's workforce to more than 350 employees by the end of summer. The company plans to add positions across manufacturing, quality assurance, and client support services.
Doug Dayhoff, CFO at INCOG, emphasized the importance of this growth: "Expanding our workforce and services is critical to meet the evolving needs of our customers who are bringing innovative drugs to patients. Our focus on attracting top talent in 2025 will strengthen our operations, foster company growth, and ensure we continue to deliver best-in-class solutions to the biopharma industry."
These new jobs are expected to contribute significantly to local economic development and create high-value employment opportunities in the Fishers region.
Building on 2024 Achievements
The planned expansion follows a year of remarkable accomplishments for INCOG BioPharma Services. Key milestones from 2024 include:
- A successful FDA inspection with zero observations, resulting in approval to manufacture a commercially approved drug
- Completion of 20 successful customer audits, including several from top global biopharmaceutical companies
- Installation of Fill Line 2
- Implementation of automated visual inspection systems
- Initiation of device assembly capabilities
- Growth of the team to 200 employees
"This past year has been a tremendous success for us, and I couldn't be prouder of our team's hard work, dedication and results," said Lewis. "These milestones are a testament to our amazing team who remains focused on INCOG's mission to bring life-saving drugs to market by serving our customers in extra-ordinary ways."
Industry Context and Significance
The expansion comes at a critical time for the biopharmaceutical industry, which continues to see increased demand for sterile injectable manufacturing capacity, particularly for complex delivery systems. As biologics and other advanced therapeutics gain market approval, specialized CDMOs like INCOG play an essential role in ensuring these innovative treatments reach patients.
The company's investment in both infrastructure and human capital positions it to address the growing need for end-to-end manufacturing solutions in the injectable space, from initial development through commercial production and packaging.
By focusing on advanced filling technologies and downstream capabilities like device assembly, INCOG is aligning with industry trends toward patient-friendly delivery systems and self-administration options for chronic conditions.
The strategic expansion reinforces INCOG BioPharma Services' position as a significant player in the sterile injectable CDMO market and highlights the company's commitment to supporting the next generation of biopharmaceutical products.
