Engineering Micelles for Antibody Capture

Capture of antibodies in biopharmaceutical processes is most commonly performed using affinity chromatography on Protein A.  While Protein A works well, the commercially available chromatography resin is expensive and its…

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Taking Charge of Charge Variants

A principal reason for why the manufacture of biologics is difficult is the structural complexity of the recombinant glycoproteins that are being produced.  As biologics production moves from research and…

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Antibodies to Watch 2019: 10 Years and Counting
Monoclonal antibody (mAb or moAb), made by identical immune cells that are all clones of a unique parent cell. Most biotech drugs are monoclonal antibodies

Antibodies to Watch 2019: 10 Years and Counting

The annual “Antibodies to Watch” article series is celebrating its 10th anniversary. Published in the journal mAbs and widely anticipated at the beginning of the new year, these articles have…

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The Impact of the Shutdown on FDA

Nancy Bradish Myers of Catalyst Healthcare Consulting in Washington, D.C., knows FDA well and recently assessed the impact of the US government shutdown on FDA.  Here’s what is happening now,…

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Abbvie IP Deal with Sandoz Will Delay Humira Competitor

We have covered biosimilars in this blog before.  Biosimilars are biological products that are similar in potency, safety and efficacy to approved reference (or “innovator”) products, but are manufactured by…

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A Nobel Nod to Cancer Immunotherapy

One of the hottest areas of medicine is cancer immunotherapy.  The importance of this field to medicine was highlighted last month with the announcement of the 2018 Nobel Prize winners…

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CAR-T cells: Beyond CD19

CAR-T cells are a new and exciting drug class in which treatment involves the use of transformed immune cells for cancer therapy. A patient’s T- cells are removed, transduced and expanded…

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Biosimilars on the Sale Rack

Biologics are the fastest-growing class of therapeutic products in the United States. As products of genetic engineering technology, they were initially introduced in the 1980s and the segment has been…

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