The requirements of drug developers often evolve as a project progresses through different stages. During the proposal phase, a sponsor may not fully understand the scope of their needs. Partnering with a flexible CDMO that offers capabilities beyond initial requirements can help prevent future roadblocks as a drug advances through its clinical journey. Below are some key characteristics that developers should consider when choosing an outsourcing partner to create a successful long-term partnership.
Staying Ahead of the Curve: Continuous Improvement & Digitization
CDMO partners with a culture focused on constantly seeking opportunities to make processes more agile and reduce the risk of errors, possess a strong understanding of their systems, and can quickly find solutions when an unexpected barrier arises. This also includes implementing digital solutions, such as electronic batch records, which allow teams to move quickly with minimal chances of error during production. This can have a significant impact on streamlining the execution of the first batch, as well as making it easier to produce subsequent batches without errors, while also helping to make it easier to share data with regulatory authorities.
Clear Communication with Reliable, Dedicated Teams
While timelines are often a central focus of proposals, the ability of a CDMO to reliably deliver on its promises is even more important. Offering an aggressive schedule is meaningless if your outsourcing partner cannot execute with consistency and quality. To ensure reliable delivery, each project should be supported by a dedicated team consisting of SMEs from supply chain, quality, MSAT, process development, and other core functions. Additionally, the use of robust project management tools and automation systems helps align expectations, improve visibility, and keep the project on track from start to finish.
Avoid Hiccups with the Handoff: Seamless Tech Transfer
The transfer of technology and processes from a developer to a CDMO is the first major test of a partnership. This is especially important for projects like late-stage or commercial projects, as the project may already be filed with multiple authorities. It’s critical for the CDMO to be able to transfer the project into their systems with as little change as possible. A manufacturing partner should have a highly experienced tech transfer team that can onboard these sensitive projects efficiently. Beyond experience, it’s important to evaluate the tools, templates, and digital systems they use to support tech transfer. These resources ensure that no deliverables or critical process steps from your internal workflows are overlooked.
Plan Ahead for Success & Future Phases
Finally, developers should look for a CDMO that can support their project across its entire lifecycle—from early clinical phases through commercial launch and beyond. A partner with comprehensive development and manufacturing capabilities increases the likelihood of long-term success. Finding a CDMO that can offer a secondary site in key geographical regions is also a plus, as your drug product is approved to be administered to patients globally.
AGC Biologics demonstrates this with flexible, state-of-the-art facilities that offer various scales and configurations, enabling us to customize production lines to meet client needs as projects progress, and support developers in the major markets where drugs are being brought to market today. Moreover, a robust R&D team ensures continuous testing and integration of new technologies and innovations, granting access to cutting-edge solutions.
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Want to learn more? Please check out our on-demand webinar with our Director of Process Transfer and Validation, as he dives deeper into this topic and discusses how we find the balance between speed and quality in drug development, plus how digitization is changing the future of the industry.
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