Throughout the lifecycle of biopharmaceutical development and manufacturing, monoclonal antibodies (mAbs) are subjected to diverse interfacial stresses and encounter various container surfaces. These interactions can cause the formation of subvisible...
OBJECTIVES: Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease. Chest high-resolution CT (HRCT) is instrumental in IPF management, and the Quantitative Lung Fibrosis (QLF) score is a computer-assisted metric for quantifyin...
Chinese Hamster Ovary (CHO) cells are the most widely used cell lines to produce recombinant therapeutic proteins such as monoclonal antibodies (mAbs). However, the optimization of the CHO cell culture process is very complex and influenced by variou...
Development of antibodies often begins with the assessment and optimization of their physicochemical properties, and their efficient engagement with the target of interest. Decisions at the early optimization stage are critical for the success of the...
Selection of lead therapeutic molecules is often driven predominantly by pharmacological efficacy and safety. Candidate developability, such as biophysical properties that affect the formulation of the molecule into a product, is usually evaluated on...
Therapeutic monoclonal antibodies (mAbs) are a successful class of biologic drugs that are frequently selected from phage display libraries and transgenic mice that produce fully human antibodies. However, binding affinity to the correct epitope is n...
In the manufacturing of therapeutic monoclonal antibodies (mAbs), mechanistic models can aid the evaluation and selection of suitable chromatography operating conditions during process development. However, model calibration remains a common bottlene...
The shift toward subcutaneous administration for biologic therapeutics has gained momentum due to its patient-friendly nature, convenience, reduced healthcare burden, and improved compliance compared to traditional intravenous infusions. However, a s...
Highly concentrated antibody solutions are necessary for developing subcutaneous injections but often exhibit high viscosities, posing challenges in antibody-drug development, manufacturing, and administration. Previous computational models were only...