By Anna Rose Welch, editor, Biosimilar Development
During our conversation about the FDA’s most recent comparability guidance, I picked one USP expert's brain about the challenges of establishing a biosimilar analytical development program, as well as why certain types of data may be more difficult to come by than others.
By Eduardo Schur, Justin Zamirowski, Atin Patel, and Maya Desai, Navigant
The number of new chemical entities gaining FDA approval more than doubled from 2017 to 2018. Global R&D spending increased 3.5 percent. The pipeline is strong, but how many innovations are actually reaching patients — and what can companies do to position their products for a successful launch?
Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.
This study is an overview of a model system for screening optimal protein purification conditions on a mixed-mode cation exchange resin using a statistical software-generated design of experiment (DOE) model with ChromLab Software’s Multivariable Scouting (MVS) function on the NGC Chromatography System.