Cynthia A. Challener

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.

Enriching process understanding enables robust process controls.

Linking structure with function is paramount.

Some progress has been made, but improvements are needed when harvesting cells for cell therapies.

Battles against antibiotic-resistant bacteria can be won with bacteriophages.

With high-concentration biologics, careful selection of excipients in formulation is crucial for reducing viscosity without destabilizing the protein.

The need to increase efficiency and productivity is driving adoption.

Careful selection is essential for achieving viscosity reduction without protein destabilization.

Analytical approaches must keep pace to ensure the identity, safety, and efficacy of evolving mRNA candidates.