Navigating Cell Therapy Process Development

Process development (PD) involves constructing an efficient and robust process, while concurrently balancing cost considerations and overall effectiveness. Although productivity remains paramount, it is imperative to also factor in cost, revenue, material sourcing, and compliance with regulatory standards. PD is essential for cell therapy developers, enabling the establishment of a standardized process that aligns with Good Manufacturing Practice (GMP) guidelines in preparation for clinical trials and commercialization.

Taking into consideration cell therapy PD optimization prior to scaling up or out can yield substantial advantages in the pursuit of commercial success. Overlooking this crucial step risks perpetuating inefficiencies that may scale with you, presenting formidable hurdles in the future. In this eBook, we explore the main challenges and considerations inherent in cell therapy process development, equipping you with the knowledge necessary to make well-informed decisions to navigate your journey with confidence and foresight.