Chamow & Associates is pleased to present a blog series detailing best practices for working with a contract development and manufacturing organization (CDMO). This series is intended to provide a potential…
Monoclonal antibodies (mAbs) as a therapeutic modality were developed over an 11-year period, from the first production of mAbs in 1975 to the first licensing of mAb therapeutic Orthoclone OKT3…
After the 2014 Ebola outbreak in West Africa, researchers wanted to test ZMapp, a new, experimental drug that had been used during that outbreak on some infected patients, along with…
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…