Featured Articles
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Automating Cell Therapy Manufacturing For GMP Compliance And Consistency
11/1/2019
Exploring the use of automation in cell therapy and advanced therapeutic medicinal product manufacturing to improve safety, quality, and compliance is a key factor in advancing patient care.
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The Parameters That Matter In Cryopreservation And Cell Thawing Process Development
6/6/2019
We are trying to simplify freezing and thawing protocols, basing them on biology and physics, and it is important to define these final steps to reduce wasting time, effort, and money. Delve into the science of cell thawing.
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Virus Reduction Of An Affinity Capture Step: Viral Clearance For Protein A
5/17/2019
Learn more about how HiScale 10/40, packed with MabSelect PrismA, is a reliable choice for the capture step in a virus clearance study.
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Viral Clearance: The Basics On How To Conduct Effective Studies
5/17/2019
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.
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GMP Cell Therapy Manufacturing: How And When To Get Started
5/2/2019
As hospitals and translational facilities explore implementation, they concurrently evaluate whether or not to manufacture the therapies onsite. Here is a guideline of how and when to get started.
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Cell Therapy Manufacturing: The Supply Chain Challenge
4/1/2019
Overcoming the challenges of manufacturing and administering a complex product to any patient is critical for delivering cell therapies. Two industry experts detail strategies to meet supply chain challenges.
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Is A Rapid Cooling Step Needed When Freezing Cells For Cryopreservation?
3/6/2019
A “rapid-cooling nucleation step” is hypothesized to improve ice nucleation – an important event for good post-thaw outcomes. Explore how a rapid-cooling nucleation step affects viable cell count and activity of four cell lines.
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De-Mystifying, De-Risking Process Development With A CDMO
11/27/2018
An overview of how CDMOs can help companies get started in the world of CGT manufacturing, with considerations around timing of engagement to maximize commercial and clinical success.
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Factory-In-A-Box Scales Up Manufacturing Of Viral Vector Based Therapies
8/31/2018
Manufacturing viral vector-based therapies such as vaccines and gene and cell therapies is complex, but a new manufacturing solution helps solve those challenges.
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Effective Separation Of Full And Empty AAV Capsids By Anion Exchange
We show how Capto Q resin with dextran surface extenders, magnesium chloride (MgCl2), and the elution salt type (especially for rAAV9) significantly enhance separation.