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Analytical Science

Discovery & Development Business Practice

Top five reasons to replace a viscometer with a rheometer

Is your viscometer approaching the end of its life? Are you starting to feel that your trial and error, ‘rheology-light’ approach to formulation is becoming dated? Or are there longstanding product performance issues that you’re failing to gain traction with, where you suspect rheology may hold the answer? 

Discovery & Development Business Practice

Dry Powder Inhaler Formulation Development

Dry powder inhalers are accepted as being complex drug products due to the interactions which occur between the active pharmaceutical ingredients (APIs) and excipients within the formulation and the way this then affects the efficiency of drug delivery by the inhaler device. Obtaining component specific particle size and particle shape distribution data can help with understanding the properties of the formulation as part of formulation or deformulation studies. This application note describes how the combination of automated image analysis with Raman spectroscopy in the Morphologi G3-ID allows the individual components present within a dry powder inhaler formulations to be independently characterized and compared.

Discovery & Development Business Practice

Determining fluorescence Limit of Detection with Nanoparticle Tracking Analysis

NanoSight instruments can also operate in fluorescence mode where only fluorescently labeled particles are detected and measured. This application note works through an experiment to approximately establish a baseline in terms of the fluorescence limit of detection for a given fluorophore.

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.

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