BioPharm International-09-01-2020

Rapid scale-up to billions of doses requires collaborative, all-out efforts by innovators, their manufacturing partners, and the entire supply chain.

The increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.

As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.

Facility and equipment design are important, but the team and its experience matter most.

Processes, people, and tools are necessary to comply with the pharmacopoeia and approved drug product registrations.

Current and newer biologic modalities pose increasingly complex challenges to the detection and characterization of protein aggregates.

Cellular and gene therapy fields are currently on track for, if not already experiencing, a serious capacity crunch.

Regulators strive to review flood of advanced treatments while also vetting COVID-19 vaccines.

Amid high expectations for a COVID-19 vaccine, biopharma readies production capacity, weighs external pressures.