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 …

tech woman

Decentralized Clinical Trials (DCT) Monthly Blog – November 2020

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 …

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.

Immunophenotyping with immunohistochemistry: interspecies considerations impacting the success of your nonclinical studies

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 …

COVIDCELLS

Key Considerations for Medical Monitoring in CAR T Clinical Trials During the COVID-19 Pandemic and Beyond

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 …