FISHERS, Ind., Feb. 15, 2024 /PRNewswire/ -- 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 at a time when securing access to capacity has become problematic for many biopharmaceutical companies.
In March of 2023, INCOG secured an additional $75 million of funding to initiate these expansion efforts. The decision to increase capacity, well before current capacity limits were reached, was based on a business philosophy that prioritizes customer needs.
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 is led by an experienced team that 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.
To that point, Lewis said, "From the beginning, we have had a big vision for what impact INCOG could make in the CDMO space. We've assembled a team with the experience and skill set to bring high-value sterile injectable drugs to the market with quality and speed. Seeing our capabilities and capacity expand when our partners need it most is exciting. We're looking forward to the new partnerships and programs we plan to support in the coming year and beyond."
If you need support on a project, please get in touch with INCOG's business development team at [email protected] or visit our website at www.incogbiopharma.com.
About INCOG BioPharma Services.
Designed to deliver better. Discover the INCOG way.
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.
SOURCE INCOG BioPharma
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