Viral clearance studies are a critical part of the production of biologics. However, performing studies that are accurate and cost-effective can be challenging. Here are seven things to consider while performing your next chromatography viral clearance study.
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. These challenges are responsible for further complicating the question about which types of data are still necessary, and why.
In this first of what will be a two-part article, USP's Fouad Atouf highlights the challenges presented by the FDA’s newest guidance while remaining optimistic that the large amount of data recommended today will open doors to more efficient development in the (hopefully) near future.
Despite the importance of the process the FDA is outlining in the guidance, I’ve surprisingly heard little chatter — positive or negative — about what the agency is now outlining and what this may mean for biosimilars and the biosimilar regulatory paradigm moving forward. Here are a couple of the biggest takeaways to note.
Mixed-mode resins are often used when unimodal resins fall short of providing the required process productivity and/or process economics. To overcome this deficiency, Bio-Rad developed the Nuvia aPrime 4A Resin with an optimal balance of ion exchange and hydrophobic interactions to deliver simultaneous purity and yield of therapeutic proteins and monoclonal antibodies that are typically difficult to purify.
This study in 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.
A new adsorbent material using a novel proprietary structure overcomes the diffusional and flow limitations of packed bed chromatography purification systems and also aims to address the capacity issues of chromatography membranes.
Evaluating how much a process step contributes to viral clearance is an essential part of process validation in order to be sure you are manufacturing safe drugs. Learn more about how HiScale 10/40, packed with MabSelect PrismA, is a reliable choice for the capture step in a virus clearance study.
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.
The traditional method of big batch manufacturing must change as companies move away from the one-size-fits-all blockbuster model toward more innovative, targeted biologics that deliver better outcomes.
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