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INCOG BioPharma Services announces it has completed the construction of its Quality Control testing laboratories, as well as the technology transfer and scale-up suite, at its headquarters in Fishers, Indiana. Shortly after INCOG employees moved into their new offices, in late December 2021, the team began installing and qualifying equipment in the 6,000 square foot laboratories at the form-fill-finish facility. INCOG will provide end-to-end QC chemistry and microbiology services, process development, and process optimization as key elements of its parenteral form-fill-finish offering. The newly designed analytical chemistry and microbiology laboratories will provide a wide range of essential biological and chemical testing capabilities to support sterile injectable drug product fulfillment programs, including sterility testing.
When fully qualified, the laboratories will enable INCOG to provide rapid turnaround times on various in-process, release, and stability testing protocols from small-scale clinical batches to large-scale commercial batches. This will also allow INCOG’s Quality and Technology Transfer experts to provide customers with the most up-to-date solutions to meet the ever-pressing regulatory requirements and stringent milestones in the biopharma industry.
Highlights of INCOG’s laboratory facilities include:
- Rapid microbiology testing
- One-day raw material/product bioburden and biological indicator results
- Seven-day sterility testing results
- Ultra-High-Performance Liquid Chromatography (UHPLC) with various detection mode capabilities
- Stability testing to meet full ICH recommended conditions
JR Humbert, VP of Quality at INCOG, shared, “INCOG’s new laboratories allow for efficient and effective method transfer into the laboratory, while simultaneously facilitating timely GMP testing delivered with upmost quality. The laboratory infrastructure we deployed lets us grow with our customers. This infrastructure also provides INCOG the capability to utilize the latest in compliant technologies to deliver accurate, rapid, and robust test results.”
Tedd Green, COO and Co-founder of INCOG, further added, “Reaching this milestone at our new facility brings us one step closer to providing our customers with turnkey manufacturing and testing services at the exceptional quality and service levels that are core to our mission.”
INCOG is investing over $100M to bring the facility on-line with the latest, state-of-the-art technology and equipment, while bringing together a talented team of experienced individuals in the injectable drug product space with a passion for delivering service. INCOG’s next major milestone is the imminent arrival, installation, and qualification of its OPTIMA Multi-Use Filling Line.
About INCOG BioPharma Services
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 experienced team, best-in-class processes, and state-of-the-art equipment, we deliver meaningful results and stand-out customer experiences. We are here to strive for the best – for our team and for our customers. We are in it 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.
INCOG BioPharma Services offers development and manufacturing services to both early phase and late phase biopharmaceutical companies. The company’s service offering includes filling drug product into vials, syringes, and cartridges. INCOG also offers support services to include formulation development, analytical development, stability testing and storage, and final inspection, labeling, packaging, and device assembly.
