Covance Blog
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 …
As biologics-based therapies have expanded, LC-MS is increasingly applied to support quantitative bioanalysis to detect diverse peptides and proteins. LC-MS can offer a few notable advantages compared to the traditional approach for quantification with ligand-binding assays (LBAs), but is typically thought of as a complementary approach.
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 …
Get insightful answers to some common questions on IND-enabling studies for cell and gene therapies (CGTs) from a recent Covance presentation. For more information on Covance solutions, visit our Cell & Gene Therapy Education Center here.
Pollinator protection is a hot topic at the moment, and deservedly so. In order to feed a global population of 7.7 billion people, we must control unwanted pests that damage food crops, without killing the insects that help produce the food; this predominantly means bees. Various claims are purported as …
Welcome to the November 2020 edition of the Covance DCT blog. The current discussions around the clinical trial industry are heavily weighted around Decentralized Trials (DCT) and how COVID19 has been a catalyst. This has heighted the awareness across our industry as we are finding many new technology companies entering this …
Demonstrating the potency of a biopharmaceutical is critical to the successful development and market release of a drug. For therapeutic antibodies, binding to the target antigen is the first step in its mechanism of action and is therefore a critical quality attribute (CQA) for the product. Since the potency assays …
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.
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 …
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 …
