time

Accelerating drug development timelines – Evolution in trial design approaches in oncology

Three specialists – Dr. Sarah Blagden, Associate Professor of Medical Oncology, University of Oxford; Maria Prendes, Head of Oncology at the Covance Biomarker Solution Center; and Kamal Saini, Senior Medical Director of Oncology at Covance – recently discussed this highly relevant topic in an educational webinar, which is now available …

stairs leading upward

Beyond Product Characterization: Analytical techniques that advance biopharmaceutical development

Evaluating your product beyond standard characterization can provide a comprehensive understanding of a molecule in early phase development. Allan Watkinson, PhD, Director of Biopharmaceutical Development CMC at Covance, recently discussed a few of the assays that can help drug development sponsors gain new insights about their product and making earlier …

testtubes

Antibody reagents for your host cell protein assay: Experience counts

The majority of biotherapeutics are produced through recombinant DNA technology using various host cell expression systems derived from bacterial, mammalian, yeast, plant or insect cells.  In the case of gene therapy products involving viral vectors, empty and partially assembled viral capsids are product related impurities that can have significant impact …

lab

What is an Inhalation reprotoxicology study – insights, advice, and secrets

What is Inhalation Reprotoxicology and When is it Relevant? Inhalation reprotoxicology studies are required when a chemical substance or plant protection product (PPP) is suspected of having the potential to cause reproductive or developmental toxicity and there is the possibility that human exposure can occur via the respiratory system.

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 …