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Analytical Science

Discovery & Development Business Practice

In-vitro bioequivalence studies

The Morphologi G3-ID can be used to compare the Active Pharmaceutical Ingredients (API) within oral solid dose formualtions. Here we apply it to comparing innovator and generic versions of a product containing two APIs.

Discovery & Development Analytical Science

Finding Fakes

| Ravi Kalyanaraman

Looking at the past, present and future of counterfeit drugs screening.

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.

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.

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