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April 2015 Issue of The Medicine Maker

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Articles featured in this issue

Business & Regulation Business Practice

The Power of the List

| Charlotte Barker

Celebrating medicine makers of all stripes in our Top 100

Manufacture Small Molecules

Cutting the Cost of Antibodies

| Stephanie Sutton

By eliminating protein A, researchers aim to deliver continuous processing at a fraction of the cost of conventional techniques

Business & Regulation Business Practice

Generic Love Triangle

| Stephanie Sutton

It’s the timeless story: Teva wants Mylan, Mylan wants Perrigo, and Perrigo wants none of it

Manufacture Small Molecules

Ebola’s Genomic Drift

| Stephanie Sutton

Media attention on Ebola has largely abated, but the outbreak is not over yet. What impact will genetic changes have on new medicines currently in development?

Manufacture Standards & Regulation

To Err is Human

| Stephanie Sutton

But can pharma manufacturers do more to help prevent medication errors?

Manufacture Small Molecules

Enzyme Evolution

| Charlotte Barker

By mimicking natural evolution of enzymes, researchers are creating biocatalysts for reactions unheard of in nature

Business & Regulation Packaging

‘Fingerprinting’ Drug Labels to Fight Fraud

| Charlotte Barker

Using tiny imperfections in the printing process to track individual products through the supply chain

Manufacture Small Molecules

The Post-Antibiotic Phage

| Rob Bragg

Will bacteriophages be the savior of the human race in the post-antibiotic era or is it just pie in the sky?

Discovery & Development Analytical Science

Making Room for Improvement

| Dennis Åsberg

To make way for more flexible approved analytical methods in pharma, we need a better understanding of the underlying scientific principles.

Business & Regulation Business Practice

The Big Leap from Academic to Entrepreneur

| Seth Lederman

If you want to launch a new drug company, you’ll need experience, drive and excellent science… not to mention a great deal of perseverance.

Business & Regulation Business Practice

Protecting Intellectual Property

When it comes to IP, large companies regularly trample over the rights of smaller firms. But by playing the game, it is possible for a small company to make IP a core revenue stream.

Business & Regulation Business Practice

Innovation in Flux

| Jon Platt

Over 70 percent of pharma leaders admit their business relies heavily on fading revenue streams – but how can we promote much-needed innovation in the current climate of uncertainty?

Manufacture Business Practice

Eye on the Prize

Novartis’ Global Head, Development Franchise Ophthalmics.

Discovery & Development Analytical Science

Glyco-Pioneer

| Sponsored by ThermoFisher Scientific

Mass spectrometry’s ever-increasing resolution has placed it at the forefront of glycan analysis. In this second article of a two-part series, we call upon the expertise of Jasna Peter-Katalinic to understand the challenges, assess the breakthroughs, and discuss the impact on the biopharma market.

Manufacture Business Practice

Beyond SOPs – Exploring the rigor and requirements of Analytical QbD

Analytical QbD (AQbD) promises to extend the rigor and benefits of QbD into the area of analytical method development. Here, Paul Kippax provides an introduction to the methodology involved and takes as an example the application of AQbD to the development of a laser diffraction particle sizing method.

Business & Regulation Business Practice

Real-time particle sizing for granulation control

This paper considers wet and dry granulation processes and the use of real-time particle size measurements in their optimization, focusing on the application of real-time laser diffraction and spatial filter velocimetry measurements.

Discovery & Development Facilities

Laser diffraction and automated imaging: complementary techniques for nasal spray development

This paper reviews the use of laser diffraction (Spraytec, Malvern Instruments) and automated imaging coupled with spectroscopic identification (Morphologi G3-ID, Malvern Instruments) in the development of nasal spray products, showing how the two techniques combine to provide the understanding and regulatory data required to develop and optimize nasal spray products in a cost and time-efficient way.

Business & Regulation Drug Delivery

Accelerating the deformulation workflow for oral solid dosage forms

In this white paper we examine the deformulation workflow, demonstrating the value of the technique of Morphologically Directed Raman Spectroscopy (MDRS) within this context. Case studies illustrate the relevance of MDRS data.

Manufacture Business Practice

The big reveal: Workhorse + Innovation = more information (Part 1)

A concern raised by the rise in routine MRI screening within the healthcare industry is that the ability to detect abnormalities within the body may currently be running ahead of our understanding of their possible consequences, making it difficult to determine a sound course of action. Here then analytical science is arguably advancing beyond current requirements.

Manufacture Clinical Trials

Characterizing Liposomes for Drug Delivery

Researchers examine the application and usefulness of nanoparticle tracking analysis and dynamic light scattering techniques in the characterization of liposomes used as drug delivery vehicles.

Other issues of 2015