In the rapidly evolving pharmaceutical industry, it is critical to stay up to date with current trends and regulatory requirements to ensure safety and efficiency in the manufacture of pharmaceuticals. This presentation will focus on the filling of highly potent liquid products.
We will begin by exploring the latest trends in pharmaceutical products, highlighting innovations and market demands that are driving the industry. Understanding these trends is essential to anticipate future developments and align manufacturing practices accordingly.

Next, we will discuss the importance of occupational exposure limits (OELs) and exposure bands (OEBs).These classifications are critical to maintaining safe working environments, especially when handling highly potent drugs.
The presentation will compare GMP requirements with Environmental, Health and Safety (EHS) requirements and explain conflicts.While both standards aim to ensure product quality and occupational safety, they have different focuses and implementation goals.

Focusing on the manufacture of highly potent products, we will discuss the specifics of plant design.This section will cover design considerations, containment solutions and the importance of validation and maintenance to ensure safe and effective manufacturing processes.

Finally, we will present a case study on the filling process of antibody drug conjugates (ADCs).This case study provides practical insights into the challenges and solutions associated with manufacturing highly potent drugs and teaches valuable lessons from real-life applications.

By the end of this lecture, participants will have a comprehensive understanding of current trends, regulatory requirements and best practices in pharmaceutical manufacturing of highly potent drugs.