Using LC-MS/MS to optimize the OECD 456 H295R steroidogenesis assay for sensitive and selective detection

Assessing in vitro steroidogenesis endpoints is an important early step in establishing the endocrine disruptor (ED) potential of your crop protection product. Many regulators worldwide now require this information as part of the registration and approval process; for example, in the E.U., the updated pesticide and biocide directives now requests information on ED potential to be included. OECD test number 456 provides in vitro mechanistic information about the impact of a chemical on steroidogenesis and this can determine if subsequent in vivo studies are needed. A reliable, sensitive and selective analytic methodology for measuring steroid hormones is, therefore, a prerequisite for success with OECD 456 – read on to find out how such a method has been optimized by using high-end technology platforms.

Business continuity: how robust is your patient support disaster relief plan?

To drive speed to therapy, reduce financial burdens and empower patient engagement, a Patient Support Services Call Center provides myriad support services that stakeholders depend upon. For pharmaceutical manufacturers, these services have gone from “nice to have” to “must-have,” driven by the growth of specialty pharmaceuticals. The complexity of treatment, advances in genetic and diagnostic testing and the high cost of specialty products require highly trained personnel, operation efficiencies and the flexibility to scale in lock-step with a product’s life-cycle stage or market conditions.

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.

Patient-Centric Sampling Evolution

As the pharmaceutical industry continues to seek ways to increase efficiency in bringing life-saving treatments to the patients who need them, a focus on both the ethical and financial benefits of patient-centric sampling has intensified. In this blog, our Director of Bioanalytical Science, Stephanie Cape, PhD, discusses the benefits, evolution and what’s next for patient-centric sampling.

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

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.

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 biologics, such as monoclonal antibodies, recombinant proteins, and vaccines. These HCPs originate from a variety of cellular sources, including the cell membrane, cytoplasm, nucleus, mitochondria, and other cellular compartments.

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.

Decentralized Clinical Trials (DCT) Monthly Blog – December 2020

Welcome to the December edition of the DCT blog. In our final edition for 2020, we look back on an eventful year.

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.