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 …

COVID

The COVID-19 road to recovery: coordinating clinical trial testing and central lab solutions

As COVID-19 was declared a pandemic, Covance Clinical Trials Testing Solutions (CTTS) witnessed a sudden influx of COVID-19 studies from both large pharmaceutical organizations and biotechs. Not only did CTTS need to accelerate the timelines for these drug development sponsors’ urgent studies, but they needed to provide patient-centric testing solutions, …

Brexit: leveraging the mutual recognition agreement to mitigate risk with commercial drug product release testing (updated 08-20)

The Brexit1 transition period is due to conclude on December 31, 2020 when the United Kingdom (UK) will become a third country to the European Union (EU). Drug manufacturers and contract test laboratories should be proactive in understanding the potential regulatory considerations relating to commercial drug product release testing and Brexit. …