Analytical Methods

The European Directorate for the Quality of Medicines & Healthcare announces the publication of a chemometric methods chapter in the European Pharmacopoeia.

The authors explore the use of precipitation using polyvinyl sulfonic acid and zinc chloride in place of capture chromatography to reduce the cost of goods in the insulin manufacturing process.

This article defines the concept, justification, and method of removal of out-of-trend points in stability modelling and shelf-life prediction.

The company’s new version of its glycan analysis tool will help investigators determine the relative abundance of individual N-glycan structures in small biopharmaceutical samples.

Protea will use Agilent’s mass spectrometry imaging technology to develop new methods to identify cell metabolites produced as a result of disease or drug exposure.

The authors evaluate the SoloVPE technique as a replacement for nitrogen-based protein determination.

Expectations are high for rapid testing methods, but demonstration of comparability proves challenging.

Advances in glycan analysis are enhancing biologics development and quality control processes.

FDA seeks feedback on possible analytical standards and approaches to optimize regulation of next-generation sequencing (NGS)-based in vitro diagnostic tests.

The authors present a review of the techniques commonly used for glycosylation analysis.

This article introduces the technology that powers automated HT–DLS and explores its practical applications in enhancing formulation stability investigations.

The authors present the results of a survey of biologics manufacturers to evaluate how these manufacturers transfer analytical methods.

Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics.

Dynamic light scattering techniques can monitor viruses and virus-like particles in their native state.

An approach to small-model generation and calibrating small-scale models to reliably predict performance at scale is presented.

Three case studies illustrate some analytical methods important for stability testing.

imagewerksBiophysical binding studies utilizing surface plasmon resonance, biolayer interferometry, isothermal titration calorimetry, or related techniques are ce

Sorendls/Getty ImagesTo maintain a state of control and comply with regulatory authorities, many pharmaceutical, biotech, and medical-device companies have adopted continued pro

The rapid microbiological growth-based method represents an alternative for the quantification of contaminants in filterable products.

The authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.

The guidance provides recommendations for submitting analytical procedures and method validation data to FDA.

The collaboration will address the need for novel analytical approaches for the characterization of glycans.

The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.

Advances in adventitious agent detection methodology are bringing benefits, but more work needs to be done.

Low endotoxin recovery represents an opportunity to add value to the characterization of biologic drug products.

This article reviews the definition of HCPs, risks posed by HCPs, regulatory concerns, commonly accepted ELISA methods for HCP measurement and their limitations, and orthogonal methods available for HCP characterization.

Higher cell densities, greater demand for high-performance viral clearance, and desire for large-scale single-use technologies are driving development of filtration technologies.

The rapid testing of biologic raw materials can lead to greater efficiency.

Liquid particle counters are ideal for protein aggregation studies.