Analytics

Nanoparticles are becoming more prevalent to overcome low solubility and poor permeability.

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.

Bob Girton, partner at Edgewater, discusses best practices for how pharma manufactures should incorporate sustainability into their operations.

Lipids aren’t the only important ingredients influencing stability and in vivo performance.

This article reviews a range of techniques available for separative analysis of mRNA therapeutics, their associated impurities, and delivery vehicles.

Considerable efforts have been made over the years to resolve the key issues of stability and delivery of RNA-based therapeutics.

Monil Malhotra, vice-president of Industrial Software at Emerson, discusses the growing demand for software solutions in the pharma industry.

Ginkgo Bioworks has acquired StrideBio's AAV capsid discovery and engineering platform and has formed a partnership with WARF for development of next-gen cell therapies.

The acquisition of Cell Systems will bolster AnaBios’ portfolio of human tissue and cells for use in drug discovery.

Michalle Adkins, director of Life Sciences Consulting at Emerson, discusses the structure of manufacturing organizations and how novel technologies may play a role in operations.

Claudio Fayad, VP of Technology, Process Systems, and Solutions discusses the intersection of automation and data security in the pharma industry.

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

Change management is central to the evolution of quality control laboratories, but what factors can maximize patient outcomes?

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.

The IsoPick from iotaSciences is designed to expand handling solutions for cell biology and gene therapy applications.

Charles River’s HCP-ELISA kit is designed to increase the efficiency and efficacy of HCP assay development.

The further we pursue CGT, the more variability we need to account for in order to engineer consistency into these new products.

Bio-Rad’s newly launched StarBright Blue and StarBright Yellow dyes are intended for use in various flow cytometry applications.

Eurofins Viracor ExPeCT CAR-T qPCR assay is a tool designed for monitoring and optimizating CAR-T therapies.

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.

The BioProfile FAST CDV is a fully automated viable cell density and viability analyzer.