Designed for QC analysts, laboratory scientists, analytical development specialists and biomanufacturing professionals seeking to expand their knowledge of advanced analytical techniques used to assess the quality, identity, purity and potency of biologics and cell-based therapies.
Learning Objectives:
- Understand sequencing technologies and their applications in quality control, including their role in product characterization, identity testing and genetic stability assessment.
- Describe cellular analytical methods used to evaluate cell identity, phenotype, functionality and quality in advanced therapies.
- Explain the principles of biophysical analytical techniques and their applications in characterizing the structural and physicochemical properties of advanced biologics.
- Understand potency assay development and implementation, including key regulatory expectations, assay selection and challenges associated with demonstrating biological activity.
- Recognize the importance of integrating advanced analytical methods into QC strategies to support product characterization, consistency and GMP compliance.
Included courses:
- Sequencing in Quality Control
- Cellular Methods
- Biophysical Methods for QC: Applications in Advanced Biologics
- Potency Assay
EST. COMPLETION 8 HRS - E-Learning format