Process characterization and viral clearance validation are pivotal studies in biopharmaceutical manufacturing, particularly for monoclonal antibodies (mAb) produced in mammalian expression systems. As the demand for these therapeutics has grown in recent years, conventional column packing and validation methods have become a bottleneck for downstream manufacturing workflows. To stay competitive, manufacturers need agile validation methods that help them work more efficiently and shorten production timelines while meeting regulatory standards.
In this GEN webinar, our expert speaker, Matt Taylor, discusses how pre-packed chromatography columns can provide reliable small-scale models of the downstream mAb purification process. He will present data that demonstrates its performance equivalency to large-scale operations, offering an efficient alternative to traditional column packing. He will discuss how these pre-packed formats fit seamlessly into process development workflows and reduce preparation time, freeing teams to focus on value-added activities while adhering to ICH Q5A guidelines.
Key takeaways from the webinar:
- Feasibility of Pre-Packed Columns as Scaled-down Models: Understand how pre-packed chromatography columns can reliably model manufacturing-scale processes for mAb purification while aligning with ICH Q5A guidelines.
- Impact on Viral Clearance Validation: Learn how pre-packed columns deliver equivalent viral clearance performance, even with aged resin, while reducing preparation and experimental cycle times.
- Operational and Productivity Advantages: Explore how eliminating column packing and validation steps frees up development resources, accelerates timelines, and enables teams to focus on higher-value activities.
A live Q&A session will follow the presentation, offering you a chance to pose questions to our expert panelist.
Produced with support from:
