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View these on-demand, 60-minute webcasts.

1. Challenges in Implementing ICH Q6B for Biologics Characterization

Characterization of a biological product by appropriate analytical techniques is necessary in development and process steps. Drug developers are challenged with keeping pace with new or modified analytical technologies. This webcast will provide an overview of the requirements outlined in ICH Q6B, Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological for analytical characterization of biological products. Challenges in determining higher-order structure and analyzing glycosylation of biologics products will be discussed in detail.

Key Learning Objectives:

  • Increase understanding of ICH Q6B
  • Learn about new analytical technologies for determining higher-order structure
  • Review methods for analyzing glycosylation of biologics products

View Challenges in Implementing ICH Q6B for Biologics Characterization.

2. The Basics of Biosafety Testing for Biologics

Detection and control of adventitious agents during the production of biologic products is a crucial part of the biomanufacturing process. In this educational webcast, an FDA expert will discuss the regulatory concerns around adventitious agent testing and an industry expert will discuss an industry initiative for risk mitigation of adventitious agent contamination in biomanufacturing. Then, a scientist from SGS will provide an overview of testing methods used to detect adventitious agents in the bulk drug substance. The webcast will conclude with a live Q&A with questions from the audience.

Key Learning Objectives:

  • Review regulatory requirements for identifying adventitious agents
  • Understand the history and scope of virus contaminations in cell culture biomanufacturing processes
  • Review pros and cons for various methods for detecting adventitious agents

View The Basics of Biosafety Testing for Biologics.

3. Regulatory, Biosafety, and Clinical Considerations for Vaccine Development

Vaccines address critical disease issues worldwide. Likewise, development and approval processes also span geographic borders, regulatory agencies, and testing criteria. This webcast will examine the regulatory framework for vaccine approval in the United States and other countries including a comparison of timelines, processes, and constraints. Biosafety issues, including adventitious agents, viruses, and appropriate testing procedures, will be discussed. A case study of viral challenge testing for vaccine development in a phase I clinical pharmacology unit will be reviewed.

Key Learning Objectives:

  • Understand key differences and milestones in vaccine approval processes
  • Identify key biosafety testing procedures that may be needed
  • Review viral challenge testing processes that can speed go/no-go decisions

View Regulatory, Biosafety, and Clinical Considerations for Vaccine Development.