The production of Advanced Therapy Medicinal Products (ATMPs) can have many complex manual steps, which necessitates meticulous aseptic processing conditions to ensure the product is sterile, which is critical for patient safety. Closed isolator systems provide a consistent, compliant, and cost-effective solution, and can play a critical role in ensuring the safety of ATMPs.

The pharmaceutical industry faces significant challenges in rapidly expanding production capacity to meet the needs of patients. Traditional centralized manufacturing models are increasingly seen as inflexible and slow to adapt to the dynamic demands of modern healthcare. This article proposes a regulatory framework for distributed manufacturing using the concept of fleet management to address these challenges.

Digital transformation isn’t a future concept in the biopharmaceutical industry—it is already impacting manufacturing and quality control processes. Recent advancements and best practices will be showcased at the upcoming 2025 ISPE Biotechnology Conference, where the track “Implementing Digital Initiatives in the Biopharmaceutical Industry: Where Are We on the Road Map?” dives deep into the real-world progress, challenges, and wins from across the industry.