cmc

Biological characterization of mAbs: role of Fc receptors in activating and regulating immune response

As well as interacting with the target antigen, antibody derived therapeutics have the potential to be able to interact with components of the immune system. Interactions with the innate immune system trigger effector functions such as antibody dependent cellular cytotoxicity (ADCC), complement dependent cytotoxicity (CDC) and antibody dependent cellular phagocytosis …

cmc

Biological characterization of mAbs: assessment of Fc-mediated effector function

As outlined in ICH Q6B “Test Procedures and Acceptance Criteria for Biotechnological/Biological Products” (CPMP/ICH/365/96), the regulatory expectation for any developmental biopharmaceutical is that a wide range of analytical methodologies are used to characterize the therapeutic. Generally, this means the application of orthogonal physicochemical and biophysical techniques to provide a comprehensive …

Optimizing ADME/hAME studies

Optimize your ADME/hAME study to overcome barriers and avoid delays for drug development success

Optimization of human absorption, metabolism, and excretion (hAME) studies, and their timing, increases the chance of drug development success, saving time and resources. This digital whitepaper provides advice and insight on how to make the right choices when planning and conducting hAME studies and how to leverage preclinical and clinical …

covancecrop1

Using LC-MS/MS to optimize the OECD 456 H295R steroidogenesis assay for sensitive and selective detection

Assessing in vitro steroidogenesis endpoints is an important early step in establishing the endocrine disruptor (ED) potential of your crop protection product. Many regulators worldwide now require this information as part of the registration and approval process; for example, in the E.U., the updated pesticide and biocide directives now requests …

Using acute respiratory disease syndrome (ARDS) in vivo models to screen for coronavirus inflammation treatment

Solutions to the current COVID-19 pandemic involve preventing coronavirus infection through vaccination and treating the severe clinical symptoms of the disease, including acute respiratory distress syndrome (ARDS). Establishing in vitro screening for potential treatments, though, can be challenging, due to the limited number of appropriate research models available, and the …