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…
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…
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…
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…
You may be aware of the diagnostic value of hemoglobin A1C in managing patients who are at risk of developing diabetes. Hemoglobin A1C is glycated hemoglobin that results from the…
We report on antibody drug conjugates, another exciting drug class that is proving to be an important tool in the fight against cancer. Leukemias, lymphomas, and myelomas are among the…
As multivalent antibodies find their way to the therapeutics market, the ability to evaluate affinity and avidity becomes a key step to their success. Separating individual binding units by cutting…
One of the first tasks necessary for recombinant production of a protein or mAb is synthesis of cDNA(s) that will encode the protein of interest. This is typically done by…
We often blog about monoclonal antibodies and the increasingly important role of this drug class in modern medicine. Monoclonal antibodies were first made possible with the development of hybridoma technology…