In this series we will be discovering what immunogenicity is, why it is important and how is it regulated and standardized.
The FDA have approved Merck’s blockbuster drug Keytruda (pembrolizumab) to treat solid tumors on the basis of genetic characteristics rather than specific type and location.
Pfizer’s proposed biosimilar, epoetin alfa, has secured approval from the Oncologic Drugs Advisory Committee becoming a step closer to potential FDA approval.
Alzheimer’s researchers have urged the FDA to update drug approval standards for Alzheimer’s drugs, in the hope to encourage research and scientific progress.
The authors demonstrate how the relationship between academia and not-for-profit organizations with large pharma and emerging biotech companies has shifted toward a more collaborative effort in bringing new therapies to the forefront.
LC–MS quantification of protein drugs: validating protein LC–MS methods with predigestion immunocapture
The purpose of this paper is to describe validation experiments that measure immunocapture efficiency, digestion efficiency, matrix effect and selectivity/specificity that can be used during method optimization and validation to test the resistance of the method to these potential interferences. The designs and benefits of these experiments are discussed in this report using an actual assay case study.
A simple, effective approach for rapid development of high-throughput and reliable LC–MS/MS bioanalytical assays
In this article, the authors describe a simple, effective approach to achieve accelerated method development of high-throughput and reliable LC–MS/MS assays for regulated bioanalysis.
Overcoming Challenges in the Development and Validation of Biologics and Small Molecules in Ocular Tissues
This webinar will demonstrate how to overcome the unique challenges associated with the distinct characteristics of ocular matrices when developing and validating ocular bioanalytical methods for biologics and small molecule drugs.
In collaboration with Bioanalysis Zone and the Society of Quality Assurance’s Bioanalytical Specialty Section (SQA-BASS), your questions about regulation and standards in bioanalysis are answered.
Dieter Zimmer reflects on two guidance documents concerning drug contamination in control samples. The author offers practical recommendations from literature and personal experience.