Cory Lewis, CEO and President
Case in point, INCOG BioPharma Services, a sterile fill-finish CDMO based in Fishers, IN was approached by a commercial biopharma company that expressed concern and dissatisfaction with the customer experience it had received from a large, well-established CDMO in the industry. Poor communication, delayed responses, and inconsistent follow-through by the CDMO led to manufacturing challenges with excessive rejection rates, low yields, and repeated delays in manufacturing their commercial drug.
The above example is just one of many where biopharma companies are struggling with on-time deliveries because of mediocre execution from CDMOs. This is the exact reason why INCOG BioPharma Services was founded by a group of industry veterans: to create a better customer experience for biopharma companies’ life-saving injectable drugs by offering state of-art technology solutions supported by an unparalleled focus on customer service.
In the case above, it was INCOG’s customer-driven mission and transparent communication that resulted in a tailored solution that provided a better overall customer experience, increased manufacturing yield, and improved the batch release process.
Backbone of Customer-Driven Success: INCOG’s Mission + Team
The backbone of INCOG BioPharma’s customer-driven focus is its team. Cory Lewis and Tedd Green—two CDMO industry leaders with 20+ years in the drug manufacturing industry – founded the company and assembled a leadership team with experience manufacturing more than 200 different molecules and 50 commercially approved therapeutics.
As part of the company’s customer-driven focus, INCOG assesses employee candidates based on their technical capabilities and their passion for putting the customer first. INCOG also uses a unique screening, onboarding, and training process that ensures every employee aligns with its values of, “All In, Lean Forward, Pull For The Team.”
When assembling a team for a customer project, INCOG also assigns an executive-level sponsor for the program's life cycle, who is actively and directly involved with the customer’s team and project meetings. This involvement ensures resource availability and prioritizes problem identification and resolution.
Beyond tactical assistance, the Executive Sponsor is also expected to bring a strategic perspective for anticipating hurdles and shortening timelines to move the clients’ therapies to the patient.
Offering Purpose-Built Customer-Driven CDMO Services
Leveraging the team’s extensive experience and state-of-art equipment, INCOG is capable of providing a wide range of manufacturing services for vials, syringes, and cartridges. These services include fill/finish manufacturing, analytical testing, quality control support, stability studies, final inspection, device assembly, and integrated storage solutions at various temperature conditions.
“We are purpose-built to be customer-driven. Our teams, facilities, and capabilities are all designed to serve a client’s most complex needs and support them across every stage of injectable drug manufacturing, from clinical through commercial supply,” says Cory Lewis, CEO of INCOG BioPharma Services.
“As an example, we built a proprietary online customer portal to facilitate sharing documents, collaborating on tasks, and communicating with the right people at INCOG in real time. We also built a suite of person-in-plant offices so that customers will always feel welcome to come on site and work face-to-face with the team. We encourage our clients to walk alongside us in the drug manufacturing process,” says Lewis.
While the backbone of the company’s approach is its team, INCOG has invested in the latest, best-in-class equipment to maximize batch yield and minimize scheduling surprises and downtime. This equipment contributes directly to efficiency and on-time delivery.
INCOG strategically selected the OPTIMA MultiUse filling line for its ability to support a broad array of filling needs and deliver ultra high manufacturing yields. The filling line can accommodate a broad matrix of ready-to-use vials, syringes, and cartridges, all on the same line, which minimizes the costs, risks, and time of future scale-up.
“We invested over $100 million at our 90,000 square feet headquarters in Fishers, IN to support 40M units of annual capacity of vial, syringe, or cartridge filling. By leveraging our industry experience with seasoned partners, we managed to convert a greenfield site to fully operational and cGMP ready by December 2022. While it typically takes 3-4 years for a new sterile fill-finish site to produce Process Performance Qualification batches, we accomplished it in just over two years.” says Lewis.
Our teams, facilities, and capabilities are all designed to serve a client’s most complex needs and support them across every stage, from clinical through commercial supply
Going beyond conventional CDMO operational standards, INCOG BioPharma Services continues to support its customer-driven mission with top talent, comprehensive services, and state-of-the art equipment to deliver best-in-class drug manufacturing customer experience for biopharmaceutical companies.
“When it comes to your supply chain, you need a simple and streamlined process to mitigate risk, minimize your time to patient, and increase value,” says Lewis. “As your CDMO partner, we know it isn’t enough to say we will help you meet your critical milestones; we need to demonstrate it. We welcome the opportunity to earn your trust and discover the INCOG way.”
