Five Qualities to Look for in a CDMO
As the biopharmaceutical industry increasingly turns to outsourcing, the key to success lies in choosing the right Contract Development and Manufacturing Organization (CDMO). A trusted CDMO partner can bridge the gap between research and commercialization and be your guide as your product advances towards market approval. This is especially true for those in the early, preclinical research phase, who may lack the extensive experience negotiating the technical and regulatory complexity of a successful process development and scale-up program. An experienced partner can make all the difference.
But the growing number of CDMOs in today’s market raises the question: how do you choose one with the expertise and technology to successfully deliver? Beyond just production capabilities, a CDMO should be a strategic partner who aligns with your values and goals. In this blog, we explore five qualities to look for in a potential CDMO partner.
Experience
The most important clue about whether a CDMO partner can deliver the quality and scale to ensure the success of a project lies in their experience. Experience means you’ve done it before and because of this history of encountering and successfully navigating various products and problems, you can do it again—and better. The more experienced a CDMO, the more likely they are to bring relevant insights, best practices, and a proven track record that contribute to manufacturing success for your product. This can save a lot of time and resources both in avoiding and overcoming problems when they do occur.
Beyond assessing experience, consider a CDMO’s reputation and overall credibility in the industry. Spend some time talking with leaders in the organization. You can quickly gauge the experience and collaborative nature of a CDMO simply by describing your project and challenges you have faced in the past. Ask to see case studies and talk to former clients to better understand a CDMO’s operational approach and ability to overcome obstacles.
Unforeseen challenges are inevitable, but the mark of a seasoned CDMO is to be able to quickly overcome problems to avoid significant delays.
Transparency
A successful CDMO partnership prioritizes transparency from the start to build a foundation of trust between both parties. In biological development, challenges are inevitable, and when they do occur, you’ll want your CDMO to be as transparent as possible and willing to openly address issues. Open, consistent communication ensures all stakeholders remain well-informed and aligned—especially in the face of setbacks. Unforeseen challenges are inevitable, but the mark of a seasoned CDMO is to be able to quickly overcome problems to avoid significant delays. This is where a strong project management team can be a key differentiator in your success. Having a team dedicated to your success, as much as you are, helps maintain open communication lines to ensure your project stays on track and moving toward success.
Quality
Top-of-mind when evaluating a CDMO is product quality. It goes without saying that if the quality of your product falls short of commercial or regulatory quality standards (i.e., low purity, presence of contaminants), there is a good chance you will get suboptimal testing results that can impact your clinical testing or worse, regulatory approval. While it can be tempting to save time, or spend less, failing to keep the end product’s quality in mind, can result in costly delays and reworks.
A quality-focused CDMO operates with a robust quality management system aligned with Good Manufacturing Practice (GMP) guidelines and industry regulations. Rigorous quality control measures, including comprehensive testing protocols and validation processes demonstrate a CDMO’s commitment to delivering products that meet or exceed quality standards that contributes to your long-term success.
Flexibility
Your CDMO should be willing to adapt to meet your needs. A “one size fits all” mentality is ill-suited for the dynamic and often unique nature of cell and gene therapy products. Finding a flexible, service-oriented CDMO able to right-size—or customize—their services based on your project, development stage, and timeline allows you to adapt and refine strategies as your project matures.
Regardless of whether a project is large or small, preclinical, clinical or commercial, great CDMO partners should be nimble and flexible in their capacity, too. CDMOs with state-of-the-art facilities and configurable production lines able to support scalable operations ensures you have a long-term partner who can meet the specific production needs at every stage of a drug product’s life cycle.
Deliverability
A reliable CDMO must be able to fulfill its commitments on time, ensuring your project stays on track both in terms of timelines and budget. Speed is a critical factor in the pharmaceutical landscape, especially in the landscape of personalized medicines and novel immunotherapies. A CDMO’s ability to deliver with speed is a strategic advantage to facilitate timely development, market entry, and patient access.
Choosing the right CDMO for your project requires careful consideration and effort. While there are more than five attributes to consider when selecting the best CDMO for your needs, the ones outlined here provide an excellent starting point as you evaluate your options. Remember, your decision on a CDMO can significantly impact the trajectory and success of your project. Opting for a CDMO like VGXI who has the experience, flexibility, and customer-centric focus can not only help get your project off the ground but also set the stage for success in the complex landscape of drug development. Our team is ready to provide insights, address your specific needs, and chart a path towards your program goals. VGXI is a leading contract developer and manufacturer specializing in nucleic acid biopharmaceuticals – Plasmid DNA – including gene therapies, DNA vaccines, and RNA medicines.
Contact us now to explore a partnership that prioritizes transparency, flexibility, and quality, to ensure the success of your biopharmaceutical program.
