Cell Therapy Manufacturing: Strategy & Optimization

The course focuses on critical areas within the cell manufacturing workflow where inconsistencies and challenges frequently occur (e.g. Product Participants will benefit from real-world case studies presented by leading academic and industry experts from North America and Europe.

WHAT YOU WILL LEARN

• Overview and applications of ICH guidelines in ATMP manufacturing processes
• Recognize the importance of product characterization and Critical Quality Attributes (CQAs) in establishing specifications and ensuring product consistency (ICH Q8, ICH Q6B)
• Apply risk-based thinking to identify and control Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) in ATMP manufacturing (ICH Q9)
• Evaluate and select appropriate partners for scaling up, including developing contingency plans when vendors no longer support or exist
• Compare and apply strategies for manufacturing scale-up and scale-out
• Implement approaches to manage contamination risks when adopting new technologies or working with new suppliers
• Understand the key time points in the product lifecycle where full analytical method validation is required to ensure data reliability, regulatory compliance, and product quality assurance
• Defining characterization and potency from a regulatory perspective
• Developing “linear-by-design” potency assay for absolute, non-relative quantification
• Advantages and challenges of cryopreserving cell therapy products, and evaluating emerging technologies that improve cryopreservation quality, manufacturing consistency, and patient safety
• Applicable regulatory requirements for performing critical assays on Human Cell, Tissue, or Cellular and Tissue-based Products (HCT/P)

DESIGNED FOR:

• Senior lab technologists, lab managers, and senior process development associates.
• It is also ideal for learners who have previously completed the Cell Product Handling & Regulatory 101 and Essentials of Cell Therapy Product Manufacturing, Qualification, and Validation on-demand courses.