Viral vector technologies are at the heart of many promising new therapies, such as vaccines, gene therapies, immune-oncology therapies and other advanced therapy medicinal products (ATMPs). In this rapidly evolving and competitive landscape, there is little scope for error or inefficiency in the development process.
A contract manufacturing and development organization (CDMO) that specializes in viral vector products can be a lifeline for process development and CMC managers, who bear the lion’s share of responsibility for ensuring their company’s innovations make it from bench to clinic as quickly and efficiently as possible. Outsourcing to a CDMO is one of the best ways to de-risk and accelerate viral vector projects—provided it is carefully planned and managed from the start. So how do you engage effectively with a CDMO and make the most of this important relationship? Here are 5 steps to a successful collaboration.
In viral vector product development, the seeds of success—or failure—are sown early. In particular, there are many challenges and pitfalls when taking a product from proof-of-concept to the first clinical trials. The decisions you make at this stage can have major consequences in terms of overall capability, reliability, quality and cost-efficiency of your process.
By reaching out to a CDMO in the early stages of development, you can benefit from the full range of their experience, capabilities and services. This usually starts with a comprehensive evaluation. For example, how scalable is your current process? Is your cell line suitable for GMP manufacturing? Do you have the appropriate analytical methods in place for in-process and release testing?
A CDMO with a strong track record in viral vector development and process engineering should be able to evaluate your project from every angle—scientific, technical, operational, cost and regulatory. An early assessment will maximize the number of design options available and ensure that strategic gaps, issues, and potential stumbling blocks are spotted early, before they become problematic.
Be clear about what you need and want from a CDMO
The first step to getting what you want from a CDMO partnership is knowing what you want. This may sound trivial, but it is surprising how often companies reach out to a CDMO with a request for proposal (RFP) before having a clear idea about exactly what they need to get out of the partnership and how they prefer to collaborate.
Before engaging with a CDMO, it is a good idea to run a gap analysis to assess your in-house capabilities and identify any gaps that you think need to be filled in terms of skills, expertise and resources. Consider also the more intangible qualities that make for a good working relationship. Intangible qualities could be your preferred communication style, the importance of compatible values, and the degree of responsiveness, flexibility and support you expect from a potential partner.
Find the right fit
With your general needs and preferences in mind, you will be in a better position to research potential CDMOs, articulate your needs, and effectively interview candidates. At the same time, it is important to remain open-minded in your initial discussions with CDMOs. In many cases they will be able to spot gaps or needs that weren’t identified in your gap analysis.
Some of the key topics to explore with potential CDMOs include:
- Range of services and competencies. Does the CDMO have the right capabilities to cover all of your needs, from virus and cell banking to regulatory sign-off and support for manufacturing handover?
- Track record in viral vector process development and clinical manufacturing. How extensive is the range of viral vectors they have successfully manufactured? Will your vector system be new to them?
- Flexibility to tailor their approach and processes to meet your vector-specific requirements.
- Equipment and facilities. Are they appropriate for your current and future needs?
- Regulatory history and experience with IND/IMPD dossier submissions. Can the CDMO prepare and provide all the necessary information for filing? Do they offer support in completing the CMC section?
- Project and program management capabilities. How experienced are they at managing complex viral vector development projects? Would you be able to trust them to drive your project forward while you focus on the high-level strategy and manage your in-house team?
- Capacity and willingness to support you at every stage of the project. Importantly, how will the CDMO prioritize your project against existing work or the needs of larger clients?
Before you make your final selection, arrange some face-to-face time with the leadership team. If possible, an on-site meeting will help you assess the culture. During such a meeting you can get a sense of what it would be like to work together. Do they listen? Are they open and easy to get along with? Do you feel comfortable working together? Is this a company you can trust to deliver?
Align and organize
Once you have found a good match, proactive engagement is key to ensure your project gets off to a good start. This includes putting the right mechanisms in place to keep the momentum going. Together with the CDMO, organize an on-site kick-off meeting to align on project vision and scope. Key milestones, priorities and ways of working can be established during the meeting. Ensure roles and responsibilities are clearly defined from the start, so there is ownership when problems arise. Along the way, take note of how quickly the CDMO gets up to speed and takes action on your requests. If they are slow to respond in signing of documents, for example, or to address your questions and concerns, this could be an early warning sign.
Maintain strong lines of communication
Lastly, never underestimate the importance of transparency and regular communication throughout your project. Establishing a schedule of communication and sticking to it will help you build strong connections and establish trust. Your CDMO should also be willing and available to participate in more impromptu discussions to work out any issues as soon as they arise. The more proactive you are about ensuring the lines of communication are open, the better able you will be to build a productive and lasting partnership.
Partnering with a CDMO can make a world of difference for your project. To discover how, talk to one of our experts. They will be happy to discuss your needs and perform a free review of your current process.
Alfred Luitjens joined Batavia in 2015. As Global Technical Director, he is our go-to expert on viral vector and viral vaccine manufacturing processes. Alfred has an extensive background in development and production of viral vectors and vaccines, with more than 30 years of industry experience. Before joining Batavia, he worked with a number of leading technology innovators including Solvay, DSM Biologics, Crucell, and GSK.