Whitepapers

In this work we demonstrate the effectiveness of Design of Experiment methodology for upstream process development through the execution of transient gene expression optimization and oxygen mass transfer characterization studies.

This application note describes the drug-to-antibody determination of brentuximab vedotin using a ternary gradient with isopropanol as third channel organic modifier.

Regulatory agencies recommend digital solutions to protect data. Explore the regulatory environment surrounding data integrity and what to look for in a laboratory information management system (LIMS) to ensure compliance.

In this paper, we present an alternative targeted metabolite profiling approach using high resolution accurate mass (HRAM) mass spectrometry with full scan analysis.

Analytical techniques are essential to ensuring the quality, efficacy, and safety of biopharmaceutical products. Advances in instruments and methods are providing biopharmaceutical drug developers, process and manufacturing managers, and quality teams with the capabilities to identify potential problem areas quickly and effectively, and to expedite drug production. In this eBook, the editors share the new technologies and methodologies to analyze and characterize monoclonal antibodies, protein therapeutics, and emerging therapies, as well as best practices to ensure the integrity of analytical test data and evaluate cleaning validation efforts.

Wastewater monitoring has been widely adopted by scientists to effectively detect and monitor infectious pathogens. Methods of detection and surveillance for SARS-CoV-2 are outlined in this paper and can be adapted for other pathogens.

Here, Sartorius provides an overview of cell line development and the associated hurdles. We will then discuss potential solutions that form part of an effective risk-management strategy and improve productivity.

Roche Pharma Research and Early Development lab automation specialist, Pawel Linke, discusses their approach to doubling the number of projects in process development without significantly increasing headcount.

Implementing a few recommended guidelines increases visibility in your distribution lane, incorporates robust materials, and qualifies them against relevant metrics to ensure consistent product quality in the cold chain.

The Sartorius-developed software, the Extractables Simulator, allows flexible combination of multiple component extractables data and prediction to facilitate the use of single-use systems in critical processing operations.

Use an HRAM LC-MS approach to cell culture media metabolite profiling to develop a targeted quantitative assay that monitors and quantifies multiple classes of cell culture media metabolites simultaneously in a single LC-MS run. Demonstrate that the developed quantitative assay can be used to support upstream processing optimization and quality control with excellent quantitative performance, high throughput and robustness.

This whitepaper discusses the potential implications on media management when implementing process intensification and explores strategies for overcoming this in both new and existing facilities.

To maintain high purity with an untagged protein, consider protein purification workflow development using the Bio Rad NGC Chromatography System, prepacked EconoFit Columns, and Stain Free gel technology. 

Read a case study about resin screening, process development, and scale-up purification of a retrovirus-like particle which was scalable, fast, and low-cost during the clinical-grade manufacture of retrovirus vectors.   

A new approach using the novel, easy-to-connect Thermo Scientific MAbPac RP capillary column for determining glycosylation site occupancy of therapeutic antibodies from the analysis of their tryptic digest.

Harnessing utilization data to drive asset lifecycle decision-making

TOYOPEARL NH2-750F resin is a salt-tolerant AEX resin ideal for the removal of endotoxins in mAb. It works in the presence of 150 mmol/L NaCl and a relatively low pH.

By measuring fundamental biophysical attributes, light scattering aids in vaccine discovery, development, and manufacture. This paper covers light-scattering characterization of vaccine classes spanning a large range of physicochemical properties.