BioPharm International, March 2022 Issue

The use of bioengineering offers practical tools for the evolution of host cells.

The authors review some of the monoclonal antibody candidates that reached Phase III clinical trials but were discontinued at later stages.

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

CGTs offer hope for the future of treatments, but the costly manufacturing, slow turnaround time, and need for supplies hinder progress.

The continuous, aseptic fill/finish process is finding use in vaccines and biologic drugs.

Emerging drug classes are giving rise to challenges in downstream processing, pushing the need for strategizing efficiencies.

Scientists can work to overcome the challenges associated with protein characterization through empowering technologies.

Optimizing the use of partners for clinical trials depends on selecting the right contractor.

Califf will face challenges that include COVID-19, opioids, and user fees.

Borrowing is good, but invention is best.

Auditors must have access to the batch records of the activities they are reviewing, says Siegfried Schmitt, vice president, Technical at Parexel.

Reducing US dependency on overseas pharma manufacturing may prove critical in navigating supply chain disruptions.