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June 2015 Issue of The Medicine Maker

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Articles featured in this issue

Business & Regulation Business Practice

The Price is Right?

| Charlotte Barker

Rising drug prices are not helping the industry’s image problem

Business & Regulation Facilities

Sterility Fears at the NIH

| Stephanie Sutton

How did the NIH get it so wrong – and how can it move on?

Manufacture Small Molecules

Managing Mutations

| Stephanie Sutton

Manufacturers must prove that new drug products are free of cancer-causing impurities

Business & Regulation Business Practice

The Innovation Game

| Stephanie Sutton

Big pharma is turning to outside sources to fill pipelines, but how often are companies backing the wrong horse?

Manufacture Vaccines

Teaching Old Drugs New Tricks

| Stephanie Sutton

Could existing drugs be repurposed as a shortcut to treating Ebola?

Business & Regulation Business Practice

Eyes on Expansion

| Stephanie Sutton

A round-up of the latest expansion plans and new facilities as building fever grips the industry

Manufacture Small Molecules

Amine Alchemy

Transforming common chemicals into complex amines is the pharmaceutical equivalent of turning lead to gold

Business & Regulation Standards & Regulation

One Framework to Rule them All

| Sam Salek

If regulators worldwide are to make good decisions in the face of complex risk–benefit profiles, a transparent and systematic approach is needed. I believe our ‘universal framework’ could be the answer.

Discovery & Development Formulation

How Does it Feel?

| James Humphrey

When it comes to topical formulations, I firmly believe that patients care about the way a cream or ointment feels – and that it plays a very important role in compliance.

Discovery & Development Clinical Trials

What Patients Want

| Abbe Steel

Most pharma companies want to become more patient focused. But how? You could start by simply listening more carefully.

Manufacture Small Molecules

How to be Fast and Flexible

| Prashant Yadav

The biopharmaceutical sector is rapidly evolving – can your supply chain keep up?

Manufacture Small Molecules

Finding Humanity in Science

| Peter Seeberger, Andreas Seidel-Morgenstern

What drives someone to throw aside selfish pursuits to focus on projects with true philanthropic impact? Here, the winners of the 2015 Humanity in Science Award provide their answers.

Business & Regulation Standards & Regulation

Countdown to Cures

| Stephanie Sutton

Is pharma keeping up with the latest innovations? US legislators say no, and are looking to a new act to accelerate approvals.

Manufacture Small Molecules

Continuous Progress

| Doug Hausner

Resistance is futile – big pharma has spoken and continuous manufacturing will be in commercial use in the near future.


Shark Attack

| Charlotte Barker

Could the unique properties of the shark immune system help us create biologics with more bite?

Business & Regulation Business Practice

Rebel With a Cause

| Charlotte Barker

Sitting Down With... Kiran Mazumdar-Shaw, Chairperson and Managing Director of Biocon, India.

Manufacture Quality & Compliance

Architects of Quality

| Sponsored by Catalent

Quality by Design: we’ve all heard the phrase – and know we should be fully on board with the philosophy. But how?

Manufacture Business Practice

Extending the boundaries of QbD

In this article Paul Davies and Paul Kippax from Malvern Instruments examine how a QbD approach can inform analytical instrumentation design and manufacture, focusing on the benefits for those who go on to use the equipment. Examples from the development of the Mastersizer 3000 particle size analyzer demonstrate the practicalities.

Business & Regulation Facilities

Investigating the de-agglomeration profiles of dry powder inhaler formulations

In this paper, Srinivas Ravindra Babu Behara, PhD, Researcher; David Morton, PhD, Associate Professor; Ian Larson, PhD, Senior Lecturer; and Peter Stewart, PhD, Deputy Dean & Professor of Pharmaceutical Sciences, all of Monash University; and Paul Kippax, PhD, Product Group Manager, Malvern Instruments, describe the use of laser diffraction to analyse dry powder behaviour. The authors introduce relative de-agglomeration versus flow rate profiles, which represent an effective graphical means to summarise the outcome of the complex interplay between the applied aerosolisation energy and the cohesive forces opposing dispersion in different powder formulations emitted from different inhalation devices. The resulting data can be used as a screening method for developing a formulation strategy for a particular active substance.

Manufacture Biosimilars

Taylor Dispersion Analysis for assessing the self-association and stability of Insulin

Using Insulin as a case study, Taylor Dispersion measurements are used to monitor self-association and oligomeric state in a variety of buffer conditions, and have the ability to render surfactants and excipients invisible in measurement data.

Manufacture Business Practice

Protein stability measurements amplified: Combining SEC-MALS and DLS to maximize data output

The stability of a protein sample and its tendency to aggregate is explored using a combination of SEC-MALS and DLS

Other issues of 2015