INCOG BioPharma Services, a contract development and manufacturing organization (CDMO), specializing in sterile injectables, has achieved another milestone by completing the installation of its state-of-the-art OPTIMA MultiUse production filling line at its Fishers headquarters.
This major milestone means INCOG BioPharma will be GMP operational and manufacturing customers’ drug products before the end of the year.
Alex Haig, Vice President of Operations at INCOG BioPharma, said: “We strategically chose the OPTIMA MultiUse line for its flexibility to support the broadest array of filling needs for our customers. 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.
“This strategic capital investment in our drug product services strengthens our position as a new standard of CDMO. 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.”
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 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% in process controls, supported by volumetric weight checks and re-dosing on demand, for each vial, cartridge, or syringe unit
Re-stoppering controls with triple checkpoint laser safeguards
System-wide recipe management system
Next up: GMP readiness
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. JR Humbert, INCOG BioPharma’s Vice President of Quality, added: “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. 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 capacity to scale and accommodate up to three filling lines, as the market for injectable drug products continues to grow.