Striking a Balance with Cost Containment
October 17, 0219
Cost plays a significant role in the development of any drug. Companies must find ways to control and lower overall spending, especially in today’s climate where drug prices have come under increased scrutiny. When it comes to process development (PD), cost containment is achieved by limiting the number of development runs. But a word of caution – to guarantee efficient process scale-up, gathering sufficient knowledge to build a robust and cost-effective manufacturing processes is mandatory. When there is insufficient process knowledge, data or high quality biological material, troubleshooting at development stage as well as large scale is extremely difficult and can be expensive. Therefore, fine-tuning process parameters at the PD stage should be focused on increasing product yield and defining process limits.
Attention to detail and gathering of process information during this phase will almost certainly enable late stage manufacturing and lead to significant cost reduction. In other words, spending more on PD may result in higher margins when the drug product is manufactured.
An excellent place to start exploring the possibility of outsourcing your PD is by fully understanding your budget. The size of your budget will be dependent upon your current process knowledge and the requirements for overall drug quantities required to fully treat your patient population.
Determining the end goal of your process and establishing the requirements for locking in an optimized and robust manufacturing process is essential. This data will provide you with a rough estimate of your overall costs. With high competition, everyone is constantly vying for funding. If you find yourself in that place, ask your preferred PD partner for help in putting together a compelling case to illustrate why proper PD funding is critical for your company’s long-term success.
Top tip: Don’t get caught up in trying to move too fast or be tempted to cut corners in areas such as process development. It is essential to ensure that your therapeutic is built on a reliable process. This will save you time, reduce risk, and avoid challenges in the future.
Learn about the challenges of making a commercially successful gene therapy in the blog post by Dr Clive Glover.
Dr Mark Szczypka – Global Director, Process Development Services
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