INCOG BioPharma Services, a US-based contract development and manufacturing organization (CDMO) specializing in sterile injectables, is adding a high-speed OPTIMA filling line that will provide an additional 100 million units of syringe and cartridge filling capacity.
 
This second filling line will be delivered on site this summer and qualified for GMP production in Q2 of 2025. It will complement the company’s existing multi-use filling line, bringing the company’s total filling capacity to 140 million units per year.
 
In addition to the new filling line, INCOG recently added automated visual inspection capabilities and will soon complete qualification of equipment to support auto-injector device assembly services. These equipment and capability upgrades pave the way for INCOG to provide high-capacity sterile injectable manufacturing.

Creating ‘A New Standard of Performance’

Cory Lewis, INCOG’s CEO, said, “We are a CDMO focused on creating a new standard of performance within our space. We are investing proactively in the equipment and people necessary to create a better customer experience. Simply put, we are committed to taking the steps necessary to give meaning to our words.”
 
Currently, INCOG supports several customer projects that include both clinical- and commercial-scale manufacturing and testing services. Those projects are utilizing an OPTIMA MultiUse filling line that has the capacity to fill up to 40 million units annually across a variety of formats, including vials, syringes, and cartridges. The system is designed to provide flexibility, while maintaining the highest quality assurance through barrier isolator and 100% in-process control technologies. The addition of automated visual inspection and soon-to-be-available auto-injector device assembly capabilities will help customers reduce time-to-market challenges.
 
INCOG has supported over 200 different molecules and projects through technical transfer and clinical/commercial supply. Furthermore, the team has contributed to the successful launch of more than 50 approved commercial therapeutics.