Ashley Harp to present at PDA Week 2025

Join CRB and other industry leaders at PDA Week 2025, April 6–11 in Palm Springs, California. This year’s theme, “Embracing Change: Catalysts for Disruption,” will explore cutting-edge trends, regulatory updates, and best practices in drug development and manufacturing. Don’t miss out on Ashley Harp’s presentation. More information below!

It’s Just Dilute Liquid (Or Is It?): Why Understanding the Risks Matters in Antibody-Drug Conjugate Processes

Monday, April 7 | 3:30 PM

This presentation offers an in-depth examination of the formulation and fill/finish processes for antibody-drug conjugates (ADCs), highlighting the unique risks associated with the manufacturing of these complex drug products. While ADCs may appear to be simple dilute liquids, the potential hazards stemming from their toxicity necessitate rigorous risk assessment and mitigation strategies. In this presentation, we will explore critical risk areas, the evaluation methods employed to identify vulnerabilities, and effective strategies to manage and overcome these risks. Emphasis will be placed on the specialized filling systems designed to safeguard personnel from exposure, particularly during the weighing, dispensing, and lyophilization processes.

Additionally, the presentation will cover regulatory compliance, including Annex 1 requirements, and the importance of automated cleaning capabilities in preventing cross-contamination and environmental impact.

1. Identify and discuss potential risk areas specific to the formulation and fill/finish processes of ADCs.
2. Understand and apply methods for evaluating risks within ADC manufacturing, focusing on personnel safety and product integrity.
3. Explore potential strategies for overcoming risks associated with the handling and processing of cytotoxic materials, including innovative design solutions and best practices for compliance with regulatory standards.

For more information about PDA Week, click here.