INCOG BioPharma Services, a contract development and manufacturing organization (CDMO) specializing in sterile injectables, recently achieved another milestone by completing the installation of its state-of-the-art OPTIMA MultiUse production filling line.
This accomplishment brings INCOG BioPharma Services closer to being Good Manufacturing Practices (GMP) certified and manufacturing customers’ drug products before the end of the year.
“We strategically chose the OPTIMA MultiUse line for its flexibility to support the broadest array of filling needs for our customers,” said Alex Haig, Vice President of Operations at INCOG BioPharma Services. “This MultiUse line enables us to process a broad matrix of ready-to-use vials, cartridges and syringes, while also supporting the ability to process bulk vials.”
The OPTIMA MultiUse filling line resides within a barrier isolator. It has a quadruple-headed filling station capable of filling multiple sizes of vials, cartridges, and syringes. Key highlights of the OPTIMA MultiUse filling line include:
- Flexibility to handle both bulk vials and ready-to-use vials, cartridges, and syringes
- Zero-waste priming capabilities during line setup
- Maximizing batch yield with 100 percent in-process controls, supported by volumetric weight checks and redosing on demand, for each vial, cartridge or syringe unit
- Re-stoppering controls with triple checkpoint laser safeguards
- System-wide recipe management system
“This strategic capital investment in our drug product services strengthens our position as a new standard of CDMO,” Haig said. “With our team working alongside OPTIMA, we managed to get the site fully operational at a record pace. We now look forward to building partnerships to support global biopharma customers with our team of experts and focused approach to doing business.”
With line installation complete, GMP qualification activities are underway. The company anticipates being GMP-ready in December 2022, less than 24 months after breaking ground on the construction of the facility.
“We’ve commissioned more than six OPTIMA filling lines in our careers, which have directly contributed to the health and well-being of millions of patients globally,” said JR Humbert, Vice President of Quality at INCOG BioPharma Services. “We’re excited to qualify another great asset to better serve patients. This filling line provides assurance that products will be manufactured to the rigorous safety and quality standards customers and patients deserve.”
The INCOG BioPharma building in Fishers has the capacity to scale and accommodate up to three filling lines, as the market for injectable drug products continues to grow. For more information about INCOG BioPharma Services, visit INCOGBioPharma.com.