Immunophenotyping with immunohistochemistry: interspecies considerations impacting the success of your nonclinical studies

Immunohistochemistry (IHC) is a useful tool for immunophenotyping because it enables the visualization of immune system cells in context of their tissue environment. This post examines IHC in relation to other immunophenotyping tools and highlights the challenges of interspecies interpretation of IHC from toxicological pathology during early drug or preclinical …


Key Considerations for Medical Monitoring in CAR T Clinical Trials During the COVID-19 Pandemic and Beyond

The following blog is an adaptation of a conference presentation by Covance in September 2020 that was also re-recorded and available here Background: Medical monitoring supports the correct determination of patient eligibility for CAR T-cell therapy and plays a key role in monitoring quality patient care throughout CAR T clinical …


Decentralized Clinical Trials (DCT) Monthly Blog – October 2020

Welcome to the October 2020 edition of the Covance DCT Blog. When sponsors consider implementing a decentralized clinical trial (DCT), one of the key challenges that has been largely aspirational until now is that the trial experience should be as seamless as possible. There are many stakeholders in any clinical …


How to answer basic physical chemical questions for your chemical and agrochemical substances when test guidance changes and as regulatory standards evolve

Although most physiochemical endpoints are standard for crop and chemical active substances, selection of the right test method to assess them is critical. This blog reviews some standard endpoints and looks at the tests used, in the light of changing regulatory expectations and revised test methodologies for difficult substances.


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 …


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 …