07.14.22 -- 2022 Outsourcing Trends In Biopharma Manufacturing

Biologics developers and manufacturers demand an accurate and reliable assay for host cell protein (HCP) quantitation. Let’s take a close look at why analytical scientists turn to the ELISA, and how it fits into process development.

Demonstration of fit-for-purpose for a drug-device combination product requires demonstration of system performance that meets regulatory requirements. This article starts with applicable regulations and guidances, and then performance risks are identified using failure modes and effects analyses (FMEA) and failure cause mapping analyses. Next, a test plan based on accepted standards is designed and executed.

This poster presents a one-year study examining performance with placebos of different viscosities (1, 8, and 15 cps.) in a laboratory configuration that replicates an autoinjector.

What can you do when the identification method defined by the USP monograph does not provide clear guidance? The authors decided to improve the method with a quality by design (QbD) approach.

Flow patterns are three-dimensional in space, and chromatography fluid dynamics (CFD) models should also be three-dimensional in space. Understand fluid dynamics within a chromatography column.

Biophysical characterization requires technologies that often require expensive reagents, high quantities of samples, and experimental conditions optimization. Simplified analytical workflows can help.