When you hire a contract development and manufacturing organization (CDMO) to manufacture your company’s biologic, you are not just signing a contract. You are entering into a technical and commercial relationship that requires mutual respect, open communication, and good business practices.
To create a successful partnership, you first need to find the right outsourcing partner. That means identifying an organization that has not only the required technical capabilities, regulatory experience, and commitment to quality, but also one that wants to work collaboratively with you. Ultimately, you want a partnership based on trust, in which the CDMO serves as your consultant.
Find a CDMO that will act as your consultant
From the beginning, even during the request-for-proposals (RFP) stage, the CDMO’s leadership team should act as your consultant, providing advice without trying to dictate what you should do with your program. This is particularly critical for a small biotech that lacks experience in manufacturing and regulatory filings.
This consultative relationship is often harder to find in a large CDMO, which might not give your company or “small” project the attention you need. A large CDMO may also have highly standardized ways of doing business and little interest in a customized approach. A specialized CDMO is more likely to value your business and be willing to work closely with you in a collaborative, consultative fashion.
Consider the physical location of your CDMO
Now that so much business is conducted remotely, the physical location of your biologics manufacturing partner might not seem important, but it is. Working with a CDMO that is on the same continent, and even in the same time zone, will help foster collaboration.
Proximity makes it easier to visit the CDMO multiple times (beyond the auditing phase), to become familiar with the team that will be handling your project. Although video conferencing goes a long way, much more interaction happens in face-to-face meetings. Ongoing communication is also easier without the complication of coordinating schedules across a large time-zone difference.
Visit the site in person, spend time at the facility during the day, and even socialize with key members of the CDMO’s team. Doing so will enable you to get to know the people and their personalities, and to establish a good rapport. Those connections will pay off when challenges arise. And yes, challenges will arise when using a living system to produce structurally complex biologic therapeutics. How your CDMO handles those challenges is what makes the difference.
Collaborate early to ensure transparent pricing
In-depth discussions about the project early in the RFP process are important to ensuring transparent pricing. The details of the product and project will enable the CDMO to prepare an accurate contract, thus helping you avoid excessive change orders that could significantly increase the overall cost of your program.
If the CDMO does not request this early collaboration, you should. It’s easy for a CDMO to offer a simple proposal, knowing that once you sign and start working with them, it will be difficult for you to change to another manufacturer, no matter how much the cost creeps up.
You should also consider this factor when comparing proposals from different biologics CDMOs. If you’re not diligent during the contracting phase, future change orders could make the cheapest proposal end up being the most expensive.
Create clear lines of communication with your CDMO
Once you sign a contract and begin working with your CDMO, decide how you will communicate, including the frequency and format. Separate biweekly technical and business meetings are recommended. As the client, however, you should receive data as it is generated, not just when your next meeting is scheduled, so that you are continually informed. You should also receive presentation slides ahead of the meetings so that you can review and prepare questions.
Both the CDMO and the sponsor should have a primary point of contact, normally a program manager. Each team also should have a primary technical contact to handle detailed discussions.
It’s also important that you share your knowledge about the product with the CDMO. Sponsors often spend years developing a biologic before getting to clinical manufacturing. It’s not realistic to simply hand it off and expect the process to be duplicated exactly—particularly with a biologic. Scale-up is complex; it’s not just a question of taking a process that worked in the laboratory and making it bigger.
And even if you choose the ideal CDMO and give them a “perfect” product to manufacture, challenges will arise. Both sides must feel comfortable making a phone call at any time to discuss concerns.
Ask your CDMO to help manage third-party relationships
A good CDMO—one that acts as your consultant—can also help you identify reliable suppliers to handle other parts of your project, such as drug product filling, clinical packaging, or distribution. The CDMO can make introductions or directly manage third-parties on your behalf.
You should expect your CDMO to coordinate with those providers just as smoothly as they do with you.
Expect excellence
In the end, of course, even with an excellent working relationship between a sponsor and a CDMO, the deliverables are what matters most. Commitments must be kept, cGMP product must be released on time, and quality cannot be compromised.
You should have high expectations from your partnership with your CDMO, and those expectations must be met.
Listen to the podcast to learn more
Learn more about developing a successful outsourcing partnership by listening to the recent episode of the “Business of Biotech” podcast, where Dr. Andrew Lees of Fina BioSolutions and Steve Lavezoli of Scorpius BioManufacturing discuss the collaboration between their companies.