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Analytical Science

Discovery & Development Business Practice

Use of microcalorimetry and its correlation with Size Exclusion Chromatography for rapid screening of the physical stability of large pharmaceutical proteins in solution

Learn how to use DSC to screen for physical stability of proteins in solution. The utility of microcalorimetry as a rapid screening tool for assessing the solution stability of high molecular weight pharmaceutical proteins was evaluated using model recombinant antibodies, Protein I and Protein II. Changes in the transition midpoint, Tm, were monitored as a function of pH and/or in the presence of excipients, and results were compared with traditional accelerated stability data from samples that were analyzed by size exclusion chromatography (SEC). The data from microcalorimetry were well correlated with those from SEC for predicting both optimal solution pH as well as excipient effects on solution stability. These results indicate that microcalorimetry can be an efficient screening tool useful in identifying optimal pH conditions and excipients to stabilize pharmaceutical proteins in solution formulations.

Manufacture Analytical Science

Protein A: a Question of Affinity

| Sponsored by GE Healthcare

Is there a future for Protein A in affinity chromatography?

Discovery & Development Bioprocessing - Upstream & Downstream

Better Bioanalytics = Better Bioprocesses

| Fredrik Sundberg

Are you up-to-date with new analytical platforms that can give you the edge?

Manufacture Biosimilars

The optimization and scale-up of high shear granulation

This article explains how an inline probe was used to monitor a granulation at three different scales to confirm that, in each case, the granules produced were the same size, and more importantly produced tablets of identical quality as quantified by hardness.

Manufacture Analytical Science

The Science of Sugar: Lessons Learned with Pauline Rudd

| Pauline Rudd

Pauline Rudd explains why sugars and glycosylation are important for biosimilars.

Discovery & Development Business Practice

Using Taylor Dispersion Analysis to determine oligomeric state of insulin

In this article, we take an introductory look at how TDA works, the information it provides and its complementary application to other techniques within the drug development workflow. In addition, example case study data will showcase the performance of TDA relative to dynamic light scattering (DLS) for assessment of the impact of a range of parameters on the monomer-dimer-hexamer equilibrium of insulin.

Discovery & Development Biosimilars

Accelerating the development of generic pharmaceuticals

In this article, triple detection SEC and MDRS are considered within the context of characterizing complex drug formulations, with specific case studies and results illustrating their application.

Discovery & Development Business Practice

Resonant mass measurement as an analytical tool

Predicting and measuring protein aggregation is a critical challenge in the formulation of biopharmaceuticals. This article describes an analytical tool that hits the ‘sweet spot’ of protein aggregation measurement

Discovery & Development Business Practice

Gold therapy using dynamic light scattering

This article explains how dynamic light scattering (DLS) can be used to gather particle size distribution data for the successful use of nanosized colloidal gold in drug delivery applications.

Manufacture Facilities

Nominations for The Power List 2017

| Stephanie Sutton

Nominations for the 2017 Power List are now open and will close on February 1, 2017.

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