#Japan #Tokyo #Quality Control #CMC Research #Antibody Drugs

Join the Live Seminar: Introduction to Quality Control Techniques for Antibody Drugs

On July 15, 2025, CMC Research will host a crucial seminar titled "Introduction to Quality Control Techniques for Antibody Drugs: Detailed Discussion on Aggregate Analysis, Removal, and Suppression Techniques". This online event, powered by Zoom, will begin at 1:00 PM JST and include on-demand viewing options, ensuring participants don’t miss valuable content. The seminar is led by Dr. Shinya Honda, a renowned researcher at the National Institute of Advanced Industrial Science and Technology and a visiting professor at the University of Tokyo.

Understanding the Importance of Quality Control in Antibody Drugs

As the demand for antibody drugs continues to surge, ensuring their quality and safety has never been more critical. Antibody drugs are complex proteins that can be unstable and prone to degradation during manufacturing processes, potentially leading to the formation of aggregates. These aggregates can not only reduce the pharmacological efficacy of the drug but may also trigger immune responses, raising safety concerns. In light of the FDA's 2014 guidance recommending that manufacturers minimize the presence of aggregates in formulations, this seminar is of paramount importance for all involved in the production and quality management of biopharmaceuticals.

What You Will Learn

Throughout this seminar, participants will gain foundational knowledge regarding the quality control of biopharmaceuticals, with a particular focus on antibody drugs. The seminar will cover the following key areas:
1. Basic Concepts in Quality Control
- Purpose and principles of quality analysis
- ICH quality guidelines for biopharmaceuticals
- Quality analysis in drug development and approval stages

2. Molecular Heterogeneity in Biopharmaceuticals
- Exploring the causes of molecular heterogeneity
- Quality management strategies and FDA perspectives

3. FDA Guidance on Immunogenicity
- Concerns around aggregation and immunogenicity
- Recommendations from FDA regarding patient-derived factors

4. Understanding Aggregates
- Definitions and classifications of aggregates
- Growth mechanisms and causes of aggregation during production

5. Analytical Techniques for Aggregates
- Methods for analyzing aggregate size and composition
- Comparison of various analytical approaches

6. Removal and Suppression Techniques
- Techniques such as chromatography for aggregate removal
- Strategies to prevent aggregation through formulation adjustments

By participating in this seminar, you will not only glean insights suited for beginners but also benefit from information relevant to experienced professionals already working in biopharmaceutical quality management.

Registration Details

The registration fees for this comprehensive seminar are as follows:

• - Regular: 49,500 JPY (including tax)
• - CMC Research Newsletter Subscribers: 44,000 JPY (including tax)
• - Academic Rate: 26,400 JPY (including tax)

This includes seminar materials and access to the recorded session after the live event.

To register and for more information, please visit our official site. We encourage everyone interested in the quality management of biopharmaceuticals to join this enlightening discussion. There will also be a Q&A segment, allowing participants to engage directly with our expert speaker.

Don’t miss this chance to enhance your understanding of antibody drug quality control and stay updated on the latest industry practices. We look forward to seeing you virtually at this important seminar!