Welcome to the December edition of the DCT blog. In our final edition for 2020, we look back on an eventful year. As we entered into the year, we had a plan for building on prior successes in patient-centric trial design. We had plans for client outreach and events to …
Bioanalysis of Biologics: Understanding the Role of LC-MS
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.
Antibody reagents for your host cell protein assay: Experience counts
In the world of biopharmaceuticals and bioprocessing, ensuring the quality, safety, and efficacy of biotherapeutic products is of paramount importance. Host cell proteins (HCPs) are a critical component to consider in this context. HCPs are proteins of the host cells, typically microbial, insect or mammalian, used in the manufacturing of …
IND-enabling Programs for Gene and Cell Therapies Webinar Questions
Get insightful answers to some common questions on IND-enabling studies for cell and gene therapies (CGTs) from our recent presentation. For more information on our solutions, visit our Cell & Gene Therapy Education Center here.
The importance of bees in crop pollination
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 …
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 …
Five critical success factors for navigating EOGRTS complexity and smoothing the progress of your chemical registration
The EOGRTS or OECD 443 is a scientifically and logistically complex study. Five critical success factors can help you overcome the complexities to achieve DART success.
How to answer basic physical chemical questions for your chemical and agrochemical substances when test guidance changes and as regulatory standards evolve
Although most physiochemical endpoints are standard for crop and chemical active substances, selection of the right test method to assess them is critical. This blog reviews some standard endpoints and looks at the tests used, in the light of changing regulatory expectations and revised test methodologies for difficult substances.
IND-Enabling programs for gene therapies
Gene therapies continue to hold promise as treatments for many diseases but there are numerous and unique challenges to developing them for submission as an Investigational New Drug (IND)/ Investigational Medicinal Product Dossier (IMPD) application for use in clinical trials. These applications require an optimized scientific program designed to address …