The approval of Zolgensma (onasemnogene abeparvovexioi) in May of this year was quite a milestone for the Cell and Gene Therapy world. Zolgensma is an Adenovirus Associated Virus (AAV)-based gene…
One of the most challenging aspects in developing new mAb therapeutics is target discovery. Identification of new, validated and preferably functional targets is difficult to sustain and is clearly a…
Because recombinant protein therapeutics are genetically engineered, they have the potential to induce an immunogenic response in a patient. Immunogenicity risk, as defined by the formation of anti-drug antibodies (ADA),…
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…