Cynthia A. Challener

Batch-to-batch variability and impurities present critical challenges.

Optimization strategies that leverage advanced technologies are essential for maximizing yield and quality.

Stability and in vivo performance aren't just affected by lipids.

The breakthrough approach is commonly used, but the devil is in the details.

Key challenges posed to autologous and allogeneic treatments could be resolved by in-vivo CAR-T gene therapies.

Process and plasmid design optimization, disposable equipment, and flexible platform processes all play important roles.

In vivo CAR-T gene therapies could overcome the challenges faced by autologous and allogeneic treatments.

Messenger RNA is inherently unstable and thus requires unique solutions to protect its cohesion.

Affinity chromatography resins must perform well under mild elution conditions yet withstand robust cleaning and sanitization protocols.

Digitalization of bioprocessing is slowly bringing benefits to the biopharma industry.