Analytical Method Development

Capturing the nuances of immune cell phenotype and function can be achieved using glycosylation analysis.

With advancements in analytical technologies, such as next-generation sequencing, the industry is transitioning towards next-gen technologies for adventitious agent testing.

Under the partnership, Sartorius will leverage SPARTA Biodiscovery’s technology to accelerate development of nanoparticles used for drug delivery.

Under the collaboration, Orionis will receive $47 million upfront to leverage its Allo-Glue platform to discover small-molecule monovalent glues.

CN Bio and LifeNet Health LifeSciences have teamed up to provide direct access to a portfolio of highly characterized hepatic cells for the creation of advanced liver-on-a-chip assays.

Illumina’s new solutions center in Bengaluru, India, will expand access to genomics in the country.

The focus in labs is leaning more heavily toward automated processes while at the same time maintaining efficiency, safety, and a personalized experience for the lab worker.

Advanced analytical tools generate more data in today’s labs than ever before.

When evaluating a drug’s risk assessment for elemental impurities, one must consider all aspects of its lifecycle.

FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.

Sandbox AQ’s molecular simulation division is collaborating with companies like AstraZeneca and Sanofi to develop novel treatments for various disorders.

E&L analytical testing methods can be determined through pointed consideration of the differences small- and large-molecule drug products.

This paper demonstrates how assay data sets of a formulated liquid product, drug substance, and an impurity, obtained from combined accuracy-precision studies, are evaluated to calculate statistical intervals (prediction and tolerance intervals) and to graphically display the total analytical error (TAE) to account for the systematic and random errors.

Mass spectrometric techniques are providing insights in critical RNA-based therapeutic areas.

Considering the differences between small- and large-molecule drug products can help determine analytical testing methods for E&L.

Under a new partnership, Invitae and Deerfield Management will harness genetic and clinical testing data from patients to discover potential novel therapeutics for treating rare diseases.

How confident are you in your lab results? This paper explores this question and, by way of a worked example, provides a methodology to answer it.

A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.

Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating analytical methods.

As the development of increasingly complex biologics grows, more robust bioassays are required to accurately characterize these molecules.

Analytical techniques for validating cleaning methods must evolve to match the pace of an increasingly complex manufacturing landscape for new therapeutics.

The launch of Discovery Life Sciences’ new Proteomic Services Division offers a single source for large-scale population studies, biobank characterization, and multi-omic biomarker analysis.

One can improve method precision and productivity by replacing one step in sample preparation with an automated approach.

Advancing digital transformation can significantly reduce R&D costs and shorten drug discovery timelines.

Although well known in R&D, PK/PD studies are an equally powerful tool for promoting successful biologic drug development.

Dissolution testing is experiencing a refresh thanks to a variety of market drivers.

Biotech startup, Cradle, has raised $5.4 million in seed funding with an AI-enabled design platform that allows for the synthetic building of cell factories to produce proteins.

Replacing a step in sample preparation with an automated approach improves both method precision and productivity.

Experts discuss factors that can affect the outcome of an ADME study, signs that a drug compound shows promise, red flags, and key parameters to determine safety and efficacy.