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May 2016 Issue of The Medicine Maker

In this issue Upfront features AC/DC (and microparticles), a new R&D showcase platform, spaceflight for fungi and more. Our cover feature asks what potential impact a Brexit may have on the pharma industry. Best Practice looks at the beginning of the end of Quality by Design and NextGen focuses on the challenges of packaging biologicals. In Profession, we find out the story behind Andrew Lees ‘magical’ career in vaccine conjugation, and Steven Schultz gives his tips for quality writing in the science environment. We also sit down with Ann Hayes, former director of drug discovery at GSK.

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Articles featured in this issue

Manufacture Technology and Equipment

Welcome to (Virtual) Reality

| Stephanie Sutton

VR is creating a buzz, but is it a game changer or gimmick?

Discovery & Development Drug Delivery

Microparticles, You’ve Been Thunderstruck

| James Strachan

Scientists use hydrophobic plasma and AC/DC’s ‘Thunderstruck’ to coat porous silicon microparticles for drug delivery

Business & Regulation Business Practice

Hive of Industry

| James Strachan

Are you a budding biotech or pharma startup? “The Hive” could be your chance to showcase your work

Business & Regulation Business Practice

Getting the Message Across

| James Strachan

What’s the best way to present a health resource? Apparently, ease of use trumps all other factors

Business & Regulation Business Practice

Pharma on a Merger Mission

| James Strachan

Abbott, Abbvie and Sanofi all make separate merger announcements – on the same day

Business & Regulation Business Practice

CSRxP Vs PhRMA

| James Strachan

A US coalition seeks lower prices for US prescription drugs, but could their proposals undermine the competitive market?

Manufacture Small Molecules

Space Biology Awakens

| James Strachan

Can the stress of space force fungi to produce novel therapeutics?

Discovery & Development Analytical Science

Cancer Static Shock

| James Strachan

Are the metrics used to measure cancer drug efficacy inherently flawed?

Manufacture Technology and Equipment

Better Together

| Vijay Chudasama

Antibody drug conjugates offer a great deal of potential for drug targeting, but what’s the best way of linking drugs and antibodies?

Manufacture Small Molecules

Beyond Counterfeiting

| Izzet Senol

Our experience with implementing serialization, has shown us that anti-counterfeiting is just one of its potential uses.

Business & Regulation Business Practice

Open Door IP

| Charlotte Berg-Svendsen

Intellectual property issues have suffocated many industry collaborations. And though IP is clearly valuable to pharma companies, there is also value in learning to let go.

Business & Regulation Business Practice

The Great British Debate

| James Strachan

As politicians and the public argue over the minor point of the UK leaving Europe, we ask a more important question: what will a “Brexit” mean for the global pharmaceutical industry?

Discovery & Development Business Practice

Trials and Tribulations

| Angus Dalgleish

Angus Dalgleish tells us about his experience with EU regulation – and why he thinks Britain should leave the EU.

Business & Regulation Business Practice

Why the BIA Says No to a Brexit

| Steve Bates

Steve Bates, CEO of the British BioIndustry Association (BIA) explains why he thinks the UK bioindustry is stronger inside the European Union.

Business & Regulation Business Practice

Helping or Hindering Science?

| Michael Merrifield, Chris Leigh

Astronomers Chris Leigh and Mike Merrifield debate how a potential Brexit might impact UK science

Manufacture Small Molecules

The Beginning of the End of Quality by Design

| Jasmine

Where did Quality by Design come from? Where will it lead to in pharma? And is there a day when the concept will no longer exist?

Manufacture Packaging

Packaging the Future

| Mike Schäfers

The term ‘packaging’ may not immediately evoke excitement – but without innovation in the field, some therapies wouldn’t even reach market. In other words, don’t judge a box by its cover because there’s more to packaging than meets the eye… and even more lies on the horizon.

Manufacture Vaccines

The Conjuror of Conjugation: Lessons Learned with Andrew Lees

Andrew Lees lightheartedly states that he has built his career on two tenets: multivalency and being lazy. And it’s worked out well; while moonlighting as a magician, he has developed the conjugation chemistry behind some of the world's most-used vaccines. Here, he explains how he learned to combine science and magic.

Discovery & Development Quality & Compliance

Language as Quality Control...

| Steven Schultz

... or sonicate until the cockroaches disappear. When writing is central to the job of assuring health, safety, and quality, can you afford to be loose with language prone to misunderstanding? Why take a chance? Here are a few strategies to edit your written work for quality control.

Discovery & Development Small Molecules

Doyenne of Discovery

| Mike Schäfers

Sitting Down With... Ann Hayes, Owner, The Ann Hayes Consultancy, Stevenage, UK.

Manufacture Bioprocessing - Upstream & Downstream

Biopharma’s Continuous Future

| Sponsored by Pall Biotech

Traditional pharma manufacturers are already dipping their toes in the waters of continuous processing, but what about when it comes to biopharmaceuticals?

Discovery & Development Business Practice

Morphologically-Directed Raman Spectroscopy used for the characterization of protein aggregates in suspension

This application note explores the use of the Morphologi G3-ID for Morphologically-Directed Raman spectroscopy (MDRS) to identify and analyze contaminants including protein aggregates present in a stressed sample of lysozyme, and to compare particles held in suspension within a thin path wet cell with those collected on a filter membrane.

Discovery & Development Formulation

Therapeutic protein products used for the differentiation and characterization of subvisible particulates

This application note provides an example of how Archimedes can be used to detect and quantify the formation of protein sub-visible particles and the introduction of silicone oil droplets, in response to shear stress.

Discovery & Development Business Practice

NanoSight Nanoparticle Tracking Analysis Concentration Measurement

The ability to compare concentration data across users, instruments and sites is a key requirement for many applications. Concentration repeatability and reproducibility are greatly improved with the application of the NTA concentration measurement upgrade, which has also been shown to reduce the influence of user selected capture and analysis settings on measurements. This application note describes the improvement in accuracy and precision of concentration measurements over a wide range of sample sizes, concentrations and materials.

Discovery & Development Business Practice

Relative viscosity screening of monoclonal antibody formulations at low concentration and viscosity

Viscosizer TD provides automated relative viscosity measurements with high reproducibility at low viscosity, to help identify molecules with abnormally high viscosity-concentration profiles at low sample concentrations as early as possible in the development pipeline

Other issues of 2016