Key Elements To Drug Product Process Characterization For Liquid And Lyophilized DP To Support A BLA Submission

The pathway to market authorization of a new biotherapeutic drug product is a lengthy one. It is complex and often not without delays along the way. However, to mitigate in many cases such inevitable roadblocks, there are strategies proven to significantly improve timelines and success to market. First of all, by adopting a risk-based approach to process validation, as outlined in the FDA’s ‘’guideline for Industry, Process Validation: General Principles and Practices,’’ data-driven evidence of a robust process and in-depth knowledge of each of the individual unit operations during the drug product (DP) manufacturing process is guaranteed to be achieved.

This webinar guides you through some of the most important initial steps to consider and implement during the process design phase (Stage 1 of Process Validation), which is a pre-requisite to a successful PPQ campaign (Stage 2) and readiness for commercial manufacturing.

There is also an opportunity to learn about Lonza’s approach to process characterization, including an insight into the more complicated operation of lyophilization, and characterization of the resulting lyophilizate, as well as describing a method of generating supportive data to enable the setting of a specification for residual moisture.

Furthermore, some key aspects belonging to the unit operation of filtration are touched on, along with essential information and recent learnings pertaining to adaptation to the new Annex I requirements for sterile manufacturing.

Key Learning Objectives:

• Strategies and prerequisites to ensure successful process characterization as part of process design
• Sterile filtration validation strategies
• Lyophilization robustness testing for input and output parameters