Anthony Garcia

Company: Kiromic Biopharma

Job title: Head of Quality Control

Seminars:

Key Considerations for Establishing a Working Cell Bank (WCB) as a Biological Raw Material for Release Testing & the Implementation into the Quality Target Product Profile (QTPP) 1:30 pm

Developmental and functional testing strategies needed to determine the proper cellular target to use based on clinical data and clinical considerations. Product characterization testing for biological AMs Key regulatory considerations and USPs needed in establishing biological raw material release testing and the stability testing needed to prove efficiency and biological effect over a certain period…Read more

day: Conference Day 1

Roundtable Discussion: An Industry-Wide Opportunity to Benchmark & Knowledge Share on Critical Quality Testing & Regulatory Considerations Associated with Establishing Master Cell Banks (MCBs) & Working Cell Banks (WCBs) to Ultimately Improve Efficiency & 2:00 pm

What kinds of challenges (analytical, regulatory, etc.) are typically faced when looking to qualify a certain type of cell line? What considerations are deemed important when establishing MCB or WCB? What was the end goal of this cell bank? What kind of release testing should be performed to release the cell bank for use and…Read more

day: Conference Day 1