Editor's note: This article ran as part of our annual CDMO profiles series, highlighting four young companies built to help pharma tackle the future of medicine.
You could say that INCOG BioPharma Services is the result of an ultimatum.
The CDMO was conceived during a 34-mile cycling journey through Maui when Cory Lewis found himself at a crossroads in his career, uncertain about the path to pursue. Lewis’ wife had strongly requested that he come to a decision about what to do next by the time the trip was over. Somewhere along the scenic route between Paia and Mt. Haleakala, the revelation struck him.
Leveraging his years of experience in the contract manufacturing sector, along with his network of connections, Lewis embarked on his next journey — to establish INCOG. He was propelled by the idea that there must be better working philosophy in the CDMO industry, specifically by taking a flexible approach to projects and putting excellent customer service at the forefront.
Lewis, partially inspired by his cycling journey, chose the name ‘INCOG’ to reflect the company’s values — ‘all in,’ ‘lean forward’ and ‘pull for the team.’ The name also signifies the company’s commitment to service.
“The ‘cog’ in our name not only reflects our connection to cycling but also symbolizes our role as a crucial component in a customer’s entire process of bringing therapies to the market,” says JR Humbert, INCOG’s vice president of quality.
Since its establishment in Fishers, Indiana in 2020, INCOG has begun to pull away from the pack. The company’s flexible approach is aimed at helping pharma clients quickly and safely bring modern sterile injectables to market. While the CDMO’s predominant focus is on biologics, it can also accommodate small molecules, peptides and mRNA products. Utilizing state-of-the-art technology and driven by a commitment to serve both clients and community, INCOG ultimately looks to offer better outcomes for patients.
Pulling for the team
While INCOG has lofty world-class aspirations, the foundation of the CDMO’s success lies in keeping its wheels grounded in its home state. INCOG’s role in Indiana extends beyond a mere presence. By deeply embedding itself in the community, the company has contributed to a growing life sciences presence in Fishers.
Located just 30 minutes north of Indianapolis, Fishers’ thriving community wasn’t built by chance but instead through INCOG’s hands-on influence.
“We had the opportunity to say, ‘Hey, we want to be all-in on Fishers. It’s a community with the potential to be the next great life sciences hub,” says Humbert.
According to Humbert, Fishers’ local government — who were transparent about not knowing much about biotech — worked hand-in-hand with INCOG to outline what the industry needed. “In response, we adopted a proactive approach, and provided essential information about the biotech industry to the mayor and his business development team,” says Humbert.
This collaborative effort paved the way for INCOG’s commitment, leading to the mayor’s decision to acquire the 75 acres that became the Fishers Life Sciences and Innovation Park. The hub has since attracted notable players like viral vector CDMO Genezen Labs and Italian drug containment and delivery solutions provider, Stevanato Group. The development not only fosters a thriving business environment but also grants eligibility for city paid infrastructure upgrades and tax breaks.
Stevanato announced the start of construction on its new U.S. facility in Fishers in fall of 2021. With an investment of approximately $145 million, the 370,000-square-foot plant focuses on expanding Stevanato’s pre-sterilized drug containment systems. The facility aims to employ over 230 local professionals in production, engineering, maintenance and corporate support roles by the end of 2025.
For INCOG, Stevanato’s investment is excellent news. “Stevanato built the machines that we’ve purchased for our facility. The fact that our service provider is going to be right around the corner gives us confidence that we will easily be able to address potential equipment issues and more easily prepare for expansion. Ultimately, this is important because it will enhance the level of service to our customers.” says Humbert.
All-in on adaptability
With its specialization in aseptic fill-finish manufacturing, INCOG is tapping into a flourishing sterile injectables market, with recent forecasts projecting a rise from $518.49 billion in 2023 to an impressive $1.02 trillion by 2030.
Ready to help meet this demand, INCOG’s 90,000-square-foot facility, scalable to accommodate up to three filling lines, is also designed with transparency in mind, with 95% of processes visible without gowning up.
“Our focus on transparency allows customers to actively participate and ensure their drug is produced as desired. It’s a unique approach with windows around most filling activities, providing an enhanced level of trust for customers to monitor the manufacturing process and contribute to the drug’s timely and accurate production,” says Humbert.
INCOG’s multi-use filling line is designed to accommodate vials and prefilled syringes concurrently, enabling seamless transitions between the two. This adaptability, Humbert says, caters to a diverse customer base at various stages of the product life-cycle journey.
“If a customer has previously manufactured in a vial and now desires a prefilled syringe, our technology allows us to produce both on the same filling line. This means we can manufacture comparability material for the vial and demonstrate it in the syringe using the same equipment,” says Humbert.
Manufacturing on a single line offers cost-efficiency, time-savings and flexibility. With streamlined processes and consistent quality, companies can swiftly adapt to market demands while simplifying regulatory compliance.
When working with high-value biologics or small clinical trial batches, guaranteeing precise fill weight targets for every unit is crucial. In INCOG’s multi-use filling line, each component is taken out of the nest in the tub, allowing for in-process weight check.
“Thanks to the 100% in-process weight check and the re-dosing on request feature, our line ensures that the first unit off the line meets the fill weight target,” says Humbert.
This de-nesting and re-nesting for syringes and cartridges also means the risk of losing units due to glass contact is minimized, which is crucial for maximizing the value of each batch.
Leaning forward
INCOG’s first client immediately put the CDMO’s adaptability to the test. The client had an existing approved drug that necessitated a transition to an ophthalmic delivery method requiring a 0.5 ml syringe with specialized small fill volumes. INCOG was able to accommodate this with its multi-use filling line.
“This line ensures swift and precise filling, enhancing the product for both patients and medical providers. The shift from the current vial storage method to the multi-use line promises improved dosing accuracy, exceeding the capabilities of the existing process,” says Humbert.
INCOG has guided the client through the entire process — tech transfer, process validation and batch stability — and the filing is currently under review by the FDA.
“If that doesn’t validate the business model, I’m not quite sure what does,” Humbert. “We are helping customers take existing products and make them better for the patients that need these medications.”
INCOG’s vision extends beyond its current offerings, with plans to increase capacity through the addition of a high-speed syringe filling and cartridge line. According to Humbert, there is an order in place and fabrication underway for the new line, and it will be GMP-ready by the second quarter of 2025.
INCOG also plans to continue expanding capacity, potentially launching a second building focused on inspection, labeling and packaging — providing a complete end-to-end solution for clients.
“Our goal is to build solid partnerships with our customers and take a full portfolio approach. We want to support multiple molecules in their pipeline, and become a trusted partner for them,” says Humbert. “Our vision is that they’re continually coming back to INCOG because they know we will support their products at every step of the manufacturing process and give them an experience they won’t find at other CDMOs.”
