Significant numbers of therapeutic small molecule drugs--as many as 40% of marketed and 90% of clinical--pose dosing and formulation challenges due to solubility issues from their hydrophobic character. Now some…
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…
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…
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…
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,…
Understanding the critical parameters that enable cells to grow to high density in a bioreactor is important to achieving a highly productive cell culture manufacturing process. Multi-omics, which is the…
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…
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…
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…
We have discussed bispecific antibodies (BsAbs) in this blog before. Teneobio, Inc., a biotechnology company in Menlo Park, CA, is developing a BsAb as a potential therapeutic for the treatment…