Novel Cell Lysis Solution: Scaling up viral vector harvest with ease and regulatory compliance

Drug products in development require compatible packaging to meet milestones and gain approval. West supports pharmaceutical partners with a data-driven process to give you confidence with closure containment that meets requirements in the modern regulatory landscape.

Small pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility. This paper explores how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations.