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Analytical Science

Discovery & Development Business Practice

Accelerate liquid formulation development for protein biopharmaceuticals

The work presented here illustrates how Differential Scanning Calorimetry (DSC) is used in the early stages of protein characterization to rapidly provide critical data about protein stability that can be used as a guide to support and accelerate liquid formulation.

Discovery & Development Business Practice

Reverse engineering of a pharmaceutical formulation

The Morphologi G3-ID can be used to generate component-specific particle size and shape data required to aid the reverse engineering of solid oral dose formulations. Here, we provide an example case study for a powder formulation.

Discovery & Development Drug Delivery

Screening, Identifying, and Quantifying Potential Genotoxic Compounds with High Resolution LC/MS

Analysis of chlorhexidine drug substance using an Agilent 6545 Accurate Mass Q-TOF System and MassHunter Mass Profiler Software.

Discovery & Development Business Practice

Thinking Inside – and Outside – the Box

Sitting Down With... Diane Paskiet, Director of Scientific Affairs at West Pharmaceutical Services, USA.

Discovery & Development Analytical Science

Ultra-Engineering UHPLC from Scratch

| Sponsored by Thermo Fisher Scientific

Incremental improvements to ultra-high performance liquid chromatography (UHPLC) have failed to deliver the tangible advances that researchers really want. Sometimes, a full overhaul by re-engineering from the bottom-up is the only way to innovate and move the field forward.

Manufacture Analytical Science

Smart Sensor Capsule

| Stephanie Vine

A capsule being developed in Ireland aims to contain not medicine, but process analytical technology.

Discovery & Development Standards & Regulation

Understanding Acceptable – Analytical Method – Submissions

| Marie Morin

Digesting regulatory guidance is not always easy, but understanding the main points – and then paying attention to the details – will improve your chances of success.

Discovery & Development Analytical Science

Data: Wanted Dead or Alive

| Ryan Sasaki

Can R&D organizations really afford to kill off analytical data that could be used for future decision-making?

Manufacture Analytical Science

Piecing Together Protein Analysis

| Sponsored by Thermo Fisher Scientific

In-depth analysis of original and new candidate drugs for biosimilars is easier than ever before…

Manufacture Standards & Regulation

A New Era of E&L Analysis

| Sponsored by Thermo Fisher Scientific

New technologies for extractables and leachables testing of small molecules and biopharmaceuticals.

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May Issue of The Medicine Maker