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 …

Covid Temp Check

Adapting oncology clinical research practices and therapeutic development strategies in the covid-19 era

The COVID-19 outbreak that began in Wuhan, China, in December 2019 was declared a pandemic on March 11, 2020 by the World Health Organization, and has since affected almost every country around the world. Cancer patients have been significantly impacted, through both clinical practice as well as engagement and participation …

lab

Combination Products: Post-marketing safety reporting

Understanding the expectations and challenges The pharmaceutical and medical device industries are seeing a substantial increase in combination products, and the related regulatory environment has been very dynamic. Recently, I was privileged to moderate a PharmaVOICE webinar on the latest U.S. FDA post-marketing safety reporting (PMSR) ruling and guidance. Expert …

COVID

Business continuity: how robust is your patient support disaster relief plan?

Weathering natural disasters and the COVID-19 pandemic To drive speed to therapy, reduce financial burdens and empower patient engagement, a Patient Support Services Call Center provides myriad support services that stakeholders depend upon. For pharmaceutical manufacturers, these services have gone from “nice to have” to “must-have,” driven by the growth …