Case Study: Challenges and Opportunities in Analytical Development for Cell and Gene Therapies

  • With no standardized methods in analytical development of cell and gene therapies, we must define our own best practices
  • Looking at the evolution and industrialization of analytical development in biologics over the past 20 years: what did we learn and how can we leverage it now?
  • With the current speed of evolution, what new tools will emerge to help us solve these complex challenges
  • The high cost of analytical development and need for greater efficiency begs the question how do we get to where we need to be… And where do we need to be?

Stacey Ma
EVP Technical Operations
Sana Biotechnology

Stacey is currently the Executive Vice President of Technical Operations at Sana Biotechnology. In this role, she is a member of the Sana Executive Team, and oversees process, pharmaceutical and analytical development, supply chain, quality, CMC regulatory, CMC portfolio and global manufacturing operations.

Prior to joining Sana in March 2019, Stacey was the Global Head of Innovation, Manufacturing Science and Technology in Genentech/Roche’s Pharma Technical Operations, responsible for driving technology and innovation in the manufacturing and testing network for all pharma products. Over her 23-year career there, she has had various leadership roles within Genentech/Roche, in both South San Francisco and Basel locations, in diverse areas such as analytical development, pharmaceutical development, quality, technical product management and supply chain.

Stacey is an internationally recognized expert in analytical sciences for biopharmaceuticals. She is a fellow of AIMBE and has co-chaired many international scientific conferences and workshops related to CMC development strategies, including several co-sponsored by FDA, EMA, and Chinese FDA. Stacey has a BS in Chemical Engineering from University of Minnesota, and a Ph.D. in Chemical Engineering from Yale University.