July 09, 2018

Is your biologics CDMO transparent?

By Cytiva

Reaping the benefits of an experienced CDMO that values transparency and open lines of communication is critical. You can not only gain expertise and experience but also valuable independence, giving you the security and longevity you need to achieve commercial success.

Collaboration with a contract development and manufacturing organization (CDMO) can help alleviate the risks associated with drug development especially when they understand how to work in a fashion that protects your intellectual property (IP). Complete transparency and open communication are key factors in doing so. But how do you know your CDMO is prepared to offer that type of commitment to your project, and what business practices should you look for to ensure they can? Here are four key considerations to help align expectations.

1. Lay a strong project foundation

In the beginning of your project, your organizations must work together to define the goals of the project and clearly outline how the CDMO’s knowledge and expertise can help execute your business strategy as well as how information will be transferred between your teams. Not only does this encourage better collaboration, but it also facilitates the handover process in the end. Identifying and outlining goals using documentation rigor and project management, both in terms of technology transfer as well as standard operating procedures for the respective equipment and platform technologies, is critical for establishing individual roles and responsibilities.

With each stage of work needed, milestones and deliverables should be identified in conjunction with the timeline. You can then track the pace of the project to make sure it is staying consistent with expectations. This also prevents you from over- or under-committing scope, which can cause misunderstandings of deliverables. Through close collaboration and discussion early on, your needs can be addressed and project deliverables are created that fulfill your expectations. Being adaptable and willing to negotiate creates trust and drives teamwork, ultimately ensuring the molecule is successful in clinic.

2. Establish effective communication: Build bridges, don’t burn them

Clear and effective communication is essential. By closing any potential gaps in communication, you eliminate delays and/or misunderstandings that often create frustration and opportunities for error. When vetting CDMOs for your project, inquire about its communication structure by asking questions like:

  • How accessible are the people in the respective areas?
  • Will they be clearly identified?
  • What’s the communication policy with respect to meeting frequency or updates?

If the CDMO does not outline a plan for effective communication, it can have a lasting effect on the strength and cohesiveness of your teams.

3. Operate as “One Team”

Mutual respect often occurs by working side-by-side to understand how the services of a CDMO are supplementing the expertise within your organization rather than replacing it. Essentially, you and your CDMO should function as one team, working to foster your relationship and facilitate knowledge transfer.

For example, a transparent CDMO that values close collaboration will allow a “person in plant” during a transparent CDMO that values close collaboration as well as manufacturing to observe in-plant activities. As this happens, the two teams strengthen their relationship and establish comfort and trust between each organization, so it can be a positive experience if subsequent support is needed later. Training also occurs throughout the project, so less time is spent doing so in the end. This transparency gives you the ability to be autonomous when you return to your facility or when you take the process back to the lab.

4. Define how your CDMO will protect your IP: Are they willing to work “Inside the Box?”

Allowing a CDMO with knowledge and expertise to support you means sharing valuable knowledge and data about your product and process. Ownership of the molecule itself almost always resides with the customer. However, defining whether there will be co-ownership or exclusive ownership of the techniques, process, and platform technologies should be identified upfront. Certain items of work might be done exclusively by the client, so processes would need to be defined on how that information is to be handed back and forth across the two teams and by whom.

You may even want some information blinded in a black box approach, which essentially protects the critical quality attributes (CQAs) of your product. A CDMO using this method receives samples from the customer to test and has an open relationship about the CQAs without ever knowing what they are. Some CDMOs may not want to work this way because it makes process development more difficult or they want a long-term relationship where, in the end, they manufacture your commercial product. If they do not have the internal capability to execute this type of approach, it should raise red flags about whether they are the right fit for your project. In addition, they should have a legal understanding of how to preserve IP for a particular entity, so both sides can move forward without any constraints.

About Fast Trak Services
Cytiva has Fast Trak service centers in the USA, Sweden, India, South Korea and China and satellite Fast Trak Centers in Turkey, Japan and Singapore. The centers are specifically designed to help biopharmaceutical manufacturers increase their process productivity, reduce cost and enable them to bring their product to market faster. Contact us for more information.