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For cell therapy developers, process development (PD) is a vital step toward commercialization. It’s your chance to root out inefficiencies so they don’t scale up with your process and to build a process that is repeatable, robust, and predictable. Careful planning can make a substantial difference on your path to commercial success. Here we delve into key considerations for helping you navigate cell therapy PD smoothly and efficiently.
Eliminate opportunities for error
Navigating the cell therapy manufacturing landscape can be complex in any case, and even more so where open and manual processes come into play. Contamination is a major risk factor in these cases and can directly impact the success of your therapies. One way to optimize your workflow for safety and efficiency? Implement closed and automated systems. By removing unnecessary manual interactions and touchpoints, you’re better able to safeguard your operations.
Digital connectivity is also crucial. Automation or services that enable you to connect, manage, operate, and monitor your equipment throughout your process will add tremendous value in terms of process efficiency and record keeping.
Know when to reach for a helping hand
For many in the cell therapy manufacturing space, optimizing PD includes challenges related to lab space, personnel, and time constraints. Consider outsourcing some development tasks to overcome these gaps effectively. A project manager can help you keep your projects on track and in budget.
Design for now and the future
Establishing repeatable processes is the goal of PD projects. To achieve this, you need to minimize variables and create a dependable, efficient design that produces consistent results without waste. Designing in equipment that is flexible and scalable will help you scale more smoothly and pivot to a different strategy if needed.
Understand regulatory requirements
As you advance towards clinical trials and commercialization, there are rigorous standards that need to be met while preparing for GMP manufacturing. It’s vital to ensure compliance with these guidelines.
Once your investigational new drug (IND) reaches phase 1, you’re largely committed to the instruments, media, and reagents you’ve used up to that point. So, it’s crucial to choose compliant and robust products to carry you through to approval.
Plan for success
Lastly, it’s important to recognize the challenges in reaching the market quickly and effectively. Knowing the potential obstacles will help you know where you may want to reach for a helping hand. Fortunately, there are experienced industry professionals available to support and enhance your development efforts.
Learn more about cell therapy solutions at cytiva.com.
