Delivering On-Time, Every Time: 4 Key Factors for Evaluating a CDMO to Improve Timelines

Dec 15, 2023

By Cory Lewis, Chief Executive Officer and President, INCOG BioPharma Services

One of the most critical requirements for biopharma companies to get their drug to market fast is to receive it “on time, every time.”  Customer surveys published in the “CDMO Outsourcing Models Edition” by ISR Reports indicate that on-time delivery is one of the most challenging aspects for biopharma companies outsourcing drug product manufacturing.

When evaluating a CDMO’s ability to deliver on time, below are four key factors biopharma companies should consider to improve on-time delivery when outsourcing drug product manufacturing.

  1. Experienced, Seasoned Team

In the complicated realm of sterile manufacturing, seasoned team members who have weathered challenges, setbacks, and roadblocks in manufacturing possess invaluable expertise compared to those with equivalent or less experience in simpler manufacturing environments. For instance, a team developing a groundbreaking biopharma drug that had to overcome unexpected manufacturing hurdles, setbacks on supply chain components, or roadblocks in quality has the street-smarts to deal with the inevitable surprises that get in the way of on-time delivery. When interviewing and evaluating CDMOs for their ability to deliver on-time, look not just at the years of experience but also the examples of the challenges, setbacks, and roadblocks experienced by the specific team members who will be assigned to your project.

  1. Flexible Equipment Design

Every biopharma company has significantly different product requirements at different scales, so flexible manufacturing capabilities are critical to help deliver on time. Imagine a sterile filling line equipped with flexible systems capable of seamlessly handling vials, syringes, or cartridges while catering to varying clinical or commercial quantities. The ability to adjust and expand quickly helps biopharma companies save time and money. They don’t have to switch manufacturing partners from vial to pre-filled syringes or clinical to commercial manufacturing. By embracing CDMOs with flexible equipment design, biopharma companies can unlock agility, enhance productivity, and ultimately help deliver their vital drugs on time to patients.

  1. Digitalization of Systems

The future of timely, on-time delivery lies in integrating a biopharma company’s decision-making process and systems with digitalizing the CDMO’s systems, processes, and data capture. Imagine a scenario where real-time data analytics and predictive modeling are shared between the CDMO and biopharma company, which helps drive better production planning and scheduling when ramping up commercial production. Both companies gain actionable insights through interconnected systems, real-time data analytics, and predictive modeling to optimize inventory purchases, minimize downtime, and proactively identify potential bottlenecks. Furthermore, a CDMO adopting automated quality control processes utilizing machine learning algorithms ensures consistent product quality while reducing manual errors, helping biopharma companies receive their drug on time.

  1. Customer Service as a Collaboration

The three points highlighted above are a great start when evaluating which CDMO can help deliver your drug on time. However, biopharma companies will still struggle to experience on-time delivery if CDMOs and biopharma companies don’t collaborate to invest in customer service with outstanding project management and communication. It takes CDMOs and biopharma companies collaborating to align their missions, values, goals, and resources around customer service if we hope to see long-lasting, meaningful improvement with on-time deliveries.

A couple of ways that CDMOs and biopharma companies can better collaborate to improve customer service include:

  • CDMOs build more in-person customer offices to encourage biopharma companies to participate in manufacturing their drug on-site. In contrast, biopharma companies prioritize spending the money, time, and resources to have employees on-site at the facility during tech transfer and manufacturing to help improve on-time delivery.
  • CDMOs and biopharma companies each contribute to an Executive Sponsor program, in which senior executives from both companies agree to build and maintain an executive-level relationship.  These relationships help to identify and more quickly troubleshoot any outstanding problems that could affect on-time delivery.

Dealing with the inevitable challenges that arise from complex sterile injectable manufacturing operations is crucial for biopharma companies to meet their expectations of delivery timelines. It starts with a seasoned team, installed flexible equipment, and digital system integration and finishes with co-investing in customer service. Though money- and time-intensive, once the relationship is built with a solid foundation to deliver on time, their partnership’s ability to deliver only improves over time.   

About the Author

Cory Lewis founded INCOG in 2020 and serves as Chief Executive Officer and President. He has spent 20+ years working in the CDMO markets and has supported global biopharmaceutical customers by securing robust manufacturing strategies that led to the approval and launch of more than 50 commercially approved therapeutics.



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