Whitepapers

Screening studies of candidate proteins are critical in biopharmaceutical discovery. Preliminary assessment of the quality of the protein solutions by dynamic light scattering is imperative for reliable binding results.

The seasonal influenza vaccine market is projected to reach more than $4 Billion USD by the end of 2022. It is a safe assumption that as demand for seasonal influenza vaccines increases, so too with the demand for contract manufacturing organizations (CMOs) to support.

The Lucullus process information management system facilitates bioprocess development and optimization by centralizing data management and control of multiple BR1000 bioreactor systems that each employ dynamic PAT-driven glucose feeding

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.