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July 2015 Issue of The Medicine Maker

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Articles featured in this issue

Business & Regulation Business Practice

The Epidemic That Cannot Be Ignored

| Charlotte Barker

Prescription drug abuse is not just a US problem.

Manufacture Small Molecules

Highly Potent; Highly Targeted

| Stephanie Sutton

A new mathematical model aims to improve drugs for cancer, viruses and bacteria

Manufacture Vaccines

Green Light for Malaria Vaccine

| Stephanie Sutton

After 28 years of R&D at GSK, the world has its first malaria vaccine

Manufacture Biosimilars

Riddle Me This, Biosimilar

| Stephanie Sutton

The first US biosimilar – Zarxio from Sandoz – has been cleared for market. But the judges say it wasn’t an easy decision

Manufacture Small Molecules

(Anti)Bacterial Factory

| Stephanie Sutton

Engineered E. coli colonies could be trump cards in the war against drug resistance

Manufacture

Biomimetic Protection of Biomolecules

| Stephanie Sutton

Porous shells – inspired by sea urchins – help defend biomacromolecules from the outside world

Manufacture Small Molecules

Recall Roundup

| Stephanie Sutton

Several companies are faced with recall woes thanks to insects, dodgy closures and broken tablets

Manufacture Small Molecules

A Blast From Potions Past

Are ancient texts hiding the answer to antibiotic resistance?

Manufacture Analytical Science

Multimodal Spectroscopy: Production Workhorse

Manufacturing is getting smarter; only a cross-discipline approach will ensure the success of tomorrow’s processes.

Manufacture Business Practice

Fake Medicine, Genuine Risk

How can we fight the global pandemic of falsified and substandard medicines?

Discovery & Development Formulation

Addiction by Prescription

Prescription drug abuse has already reached epidemic proportions in the US – and other countries look set to follow the dangerous trend.

Business & Regulation Formulation

A Cat and Mouse Game: The Evolving Landscape of Abuse-Deterrent Formulations

| Charlotte Barker

Abusers are finding ways to circumvent current abuse-deterrent measures, leaving companies in need of new strategies.

Manufacture Small Molecules

Is Biopharma Ready to Say Goodbye to Batches?

Very few biologics are made using continuous processing equipment like bioreactors. Clearly, the biopharmaceutical industry has a long way to go before it’s ready to embrace (potentially) superior manufacturing models. Why?

Manufacture Small Molecules

Decision Support

Suzanne Farid is Professor of Bioprocess Systems Engineering and Co-Director of the ESPSRC Center for Innovative Manufacturing in Emergent Macromolecule Therapies hosted by the Department of Biochemical Engineering at University College London.

Discovery & Development Business Practice

Fighting Fear – the Entrepreneur’s Enemy

The true path to success as an entrepreneur is the ability to spot high impact problems – and to be fearless in the pursuit of great solutions.

Manufacture Small Molecules

Precision Biomanufacturing

Personalized medicine looks set to transform the biopharmaceutical landscape, and will demand significant changes in production methods. The demand for large-scale batch processes will decline – so what is the alternative? The UK’s new National Biologics Manufacturing Center is on a mission to answer that very question.

Business & Regulation Biosimilars

The Business of Biosimilars

| Charlotte Barker

Sitting Down With… Carsten Brockmeyer, CEO, Formycon, Germany.

Business & Regulation

The Medicine Maker Innovation Awards 2015

| Charlotte Barker

The December issue will feature our inaugural Innovation Awards, recognising the most exciting new technologies of 2015.

Discovery & Development Standards & Regulation

Holistic Bioanalytics in the Clinic

| Sponsored by Agilent

Lawrence (Larry) Lesko is a bioanalytical veteran with many years of academic and FDA experience under his belt. Now, as director of the University of Florida’s Center for Pharmacometrics and Systems Pharmacology, Larry uses metabolomics to discover biomarkers of drug toxicity.

Manufacture Business Practice

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

The techniques of laser diffraction and automated particle imaging support the fast, cost-effective development of nasal spray products, simultaneously providing the data required for regulatory compliance. This paper examines their application.

Manufacture Business Practice

Nanoparticle Tracking Analysis: Principles and Methodology

Nanoparticle Tracking Analysis represents a rapid and information-rich multi-parameter nanoparticle characterization technique allowing the user to obtain number frequency particle size distributions of polydisperse nanoparticulate systems. It has resulted in its rapid adoption as an interesting new technique in a wide range of sectors within the pharmaceutical sciences. This Chapter 5 addresses some of the latest work reported in the literature in which NTA has been proposed, used and assessed in the study of nanoparticle-based drug delivery and targeting.

Business & Regulation Business Practice

Studying low-affinity fragments of ligands by ITC

Dissecting a ligand into smaller fragments can provide a strategy for analyzing the role of key functional groups in a protein-ligand interaction. Conversely, low-affinity ligand fragments that are able to occupy a receptor-binding site simultaneously, can often be linked together to form high-affinity inhibitors. The key challenge to such studies lies in measuring the thermodynamics of low-affinity interactions. This white paper will address the issues of studying low-affinity systems by isothermal titration calorimetry (ITC). Topics will include working with receptor concentrations below KD (i.e., low c-values), and how displacement techniques can be employed to measure very low affinities while still complying with the c-value rule. Illustrative examples will be drawn from studies with carbohydrate-binding proteins.

Other issues of 2015