BioPharm International, 2021 Biopharmaceutical Analysis eBook

The ever-increasing complexity of biotherapeutic molecules presents unique analytical challenges for developers.

Developing analytical methods and bioassays is necessary from early on in the drug development life cycle.

Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.

Gene therapy products present a unique set of challenges for the control of host cell protein impurities.

Sophisticated analytical technologies are complementing traditional approaches in the identification of residual process-related impurities of biotherapeutics.

Microfluidic Modulation Spectroscopy is a recent innovation in infrared spectroscopy techniques that improves elucidation of secondary protein structure.

As recent COVID-19 vaccine facility citations make clear, failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.