Cynthia A. Challener

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.

Increasing molecular diversity is creating a need for the reinvention of process development and control strategies.

Both demand for and investment in fill/finish capacity continue to rise.

A holistic view of the product, manufacturing, and ultimate use of the viral vector is required.

Manufacturers are taking the first steps toward process intensification.