The complexities of today’s biologics and intensifying competition in the industry are making it more important than ever to develop a successful first-to-market strategy. Collaboration with a contract development and manufacturing organization (CDMO) can make it possible to bring your drug to market — and to patients — faster, as additional resources allow your operations to run more smoothly, and you can react faster when problems arise. Nonetheless, handing over vital information about your product can understandably feel like you are giving up, or even losing power over, your own project.
That is why it is important to find a partner who can help alleviate the risks associated with drug development but also understands 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?
1. Lay a strong project foundation
In the beginning of your project, a CDMO will want to complete exploratory work to determine any optimization opportunities that can create the most efficient process. The more information you include in your request for proposal (RFP), the better, so the CDMO has the information they need to propose the most effective changes. Your organizations must then 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 facilities 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 that is identified, 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. It also prevents you from over- or under-committing scope, which can cause misunderstandings of deliverables. Template documents, such as for batch records, process records, etc., can lay a foundation for the project but should be revised in accordance with the project needs. This offers the benefit of efficiency while still capturing the unique features of your specific technical details. Although there is a minimum criterion a cGMP manufacturing facility must abide by, the templates allow a CDMO to accommodate enhanced testing or quality evaluations, such as additional analytical test methods for a particular molecule.
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. Project management and oversight is a full-scope component from the earliest stages of the project to its completion. As part of that project management, project teams must be identified with their emails, phone numbers, and any other forms of communication. People should be introduced right away, so everyone is familiar with whom their technical and non-technical counterpart is and can build bridges among those teams (i.e., upstream, downstream, quality, analytical, etc.). This not only creates the initial connection between the appropriate departments, but it also helps build a larger and more cohesive team.
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?
Ideally, they should offer a clear pathway for communication that provides you with outlets where you can reach out and ask questions at any point in the project. 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”
Like any successful relationship, the importance of trust and respect cannot be understated, and valuing each other’s expertise is a crucial part of forming a strong business partnership. Often, this mutual respect 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 optimization of the development process as well as manufacturing to observe in-plant activities. This provides you with the opportunity to view processing firsthand as well as see the progression of the process first hand and completion of the respective steps. By asking questions and hearing the logic behind all of the decisions being made, you can gain a deeper understanding of the process in real time. Additionally, it gives your experts a chance to jump in when critical or even non-critical decisions need to be made, as well as to help troubleshoot.
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 the process is taken 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 up front. 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.
An open partnership depends on how the CDMO manages its customer on-site. It is up to you to vet any potential CDMOs and find out how open they are willing to be over the course of the relationship. Ask questions, such as does the CDMO allow both teams to work openly in a pilot plant, or is your team allowed only in specific areas of the building during processing steps? Also, find out what the CDMO intends to provide at the end of the project. Does it provide documentation, such as analytical testing requirements and SOPs, and will it speak openly with you to support it on an ongoing basis, even after the service work is rendered?
In the end, reaping the benefits of an experienced CDMO while protecting your process know-how and securing a successful transfer of knowledge can be challenging. The pace at which drug development moves also adds a layer of complexity and a sense of urgency. However, working with a 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.
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.