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October 2015 Issue of The Medicine Maker

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Articles featured in this issue

Business & Regulation Business Practice

Hiding in Plain Sight

| Charlotte Barker

Mislabeled, substandard or falsified medicines are the perfect opportunity for criminals looking for low risks and high rewards.

Business & Regulation Standards & Regulation

Too Fast and Furious?

| Stephanie Sutton

Expedited regulatory approvals bring medicines to market faster – but are they the right drugs?

Manufacture Small Molecules

Digging for Drugs

Genome mining hunts for bacteria micro-chemists that could help develop innovative drugs

Discovery & Development Drug Delivery

The Medicine Monitor

A digital pill submitted for regulatory approval tells caregivers if you’ve taken your medicine

Discovery & Development Formulation

Benign by Design

Making drugs greener for our environment and water supply

Manufacture Technology and Equipment

Big Pharma Gets Played

| Stephanie Sutton

As the industry makes its video game debut, the big question is: will you prioritize patients over profit? Here’s our big review.

Business & Regulation Standards & Regulation

All Change at the Top

| Stephanie Sutton

The EMA fights to reinstate its former executive director – and the FDA’s new leader is still unconfirmed

Discovery & Development Clinical Trials

Cancer Complexity

| James Ritchie

Clinical development is outmoded; we are witnessing serious attrition in cancer R&D. Perhaps it’s time to live and die by the mantra: “no biomarker, no trial”.

Manufacture Quality & Compliance

Painting a Better Picture of Quality

| Christian Mänder, Thomas Friedli

When seeking to measure quality across an organization, what is the right approach? We propose to use the synergies of Quality and Operational Excellence programs – and we are sure you will see the benefits.

Manufacture Facilities

Embracing Rapid Microbiology

| Tim Sandle

Microbiological approaches are faster and more advanced than ever before – so why on earth isn’t the pharma industry using them?

Manufacture Standards & Regulation

When Fakes Attack!

Counterfeit medicines are on the rise. Regulators are driving serialization and tamper-evident packaging initiatives, but is the pharma industry fully primed to defend against fraud and push back the forgeries?

Business & Regulation Business Practice

The Problem of Counting Counterfeits

| Stephanie Sutton

Tim Mackey is the Director of the Global Health Policy Institute and an assistant professor at UC San Diego – and he has written numerous articles on the subject of counterfeit medicines.

Business & Regulation Business Practice

Fighting Spirit

| Stephanie Sutton

Grant Lindman is director of Eli Lilly’s global anticounterfeiting operations and is passionate about fighting fake medicines.

Manufacture Technology and Equipment

Fighting Fakes

Track and trace is often used on pharmaceutical packaging but what if an invisible code could be applied directly to a tablet?

Manufacture Bioprocessing - Single Use Systems

Disposing of the Past and Embracing Single-Use Technology

| Stephanie Sutton

Single-use technology is ready to lend a helping hand to biomanufacturing, but is the industry ready to turn away from stainless steel? A hybrid manufacturing model could benefit from the best of both worlds.

Manufacture Advanced Medicine

The Hype, Hope and Reality of Personalization

Personalized cell-based therapies have been hyped as the future of medicine, but are current manufacturing technologies up to the task?

Business & Regulation Business Practice

Harnessing Emerging Markets

| Ambuj Jain

The emerging markets are home to 85 percent of the world’s population and represent a potentially massive source of untapped consumption. How can the pharma industry capitalize on this huge, underserved market?

Business & Regulation Small Molecules

An Instinct for Innovation

| Stephanie Sutton

Sitting Down With... John Talley, Chief Scientific Officer at Euclises Pharmaceuticals, St. Louis, USA.

Manufacture Bioprocessing - Single Use Systems

Bringing Vaccines into the 21st Century

| Sponsored by GE Healthcare

Medicine manufacturing has benefited from countless advances in technology over the last few decades, and yet many vaccines are still being produced with decade-old processes. Change is never easy, but is falling behind really an option?

Discovery & Development Formulation

The Medicine Maker × Catalent Applied Drug Delivery Institute

| Sponsored by Catalent

There are many hurdles in drug development, but your chances of success increase significantly if you pay more attention to API optimization from the outset.

Manufacture Technology and Equipment

Realizing 3D Potential by Printing a Clearer Picture

Inkjet printing has the potential to transform the ways in which pharmaceuticals are developed, manufactured and delivered to the patient.

Discovery & Development Drug Delivery

Printing Medicines for Express Delivery Through the Cheek

For the past decades, the buccal epithelium (inner side of the cheek) has been explored as a potential administration route for drugs. This route is particularly favored for the administration of biologics because of its systemic circulation drainage and low enzymatic content, as well as the fact that it bypasses the gastrointestinal tract.

Manufacture Business Practice

Utilization of kinITC in AFFINImeter

This application note describes how and when can kinetic information be retrieved from ITC power curves. The results shown here were obtained with programs developed with Mathematica from Wolfram Research, which was employed to implement and validate the method. The underlying algorithms were all introduced into AFFINImeter.

Manufacture Business Practice

Characterization of IgG monomers & their aggregates

Two antibody samples were characterized using column calibration and multi-detection SEC, and the results compared to show how multi-detection SEC provides more accurate data and a more complete characterization of the protein mixtures under study.

Discovery & Development Drug Delivery

Using Raman Spectroscopy to Understand the Conformational Stability of Protein Therapeutics

Use of a novel combination of dynamic light scattering and Raman spectroscopy to elucidate the conformational stability and structure of proteins in biopharmaceutical formulations

Discovery & Development Drug Delivery

Overview of Key Principles of Dynamic Light Scattering to protein therapeutic formulations – Part 1

This four-part series examines common issues and questions surrounding the principles, measurements and analysis of DLS data and discusses how to minimize the time required for and increase the accuracy of acquiring and interpreting DLS data during the biotherapeutic development process. In Part One, we provide an overview of the key principles of DLS: theory, correlation statistics, deconvolution algorithms, and the intensity to mass transform.

Discovery & Development Drug Delivery

Overview of Key Principles of Dynamic Light Scattering to protein therapeutic formulations – Part 2

This four-part series examines common issues and questions surrounding the principles, measurements and analysis of DLS data and discusses how to minimize the time required for and increase the accuracy of acquiring and interpreting DLS data during the biotherapeutic development process. In Part Two, we cover the influence of concentration effects and particle interactions on DLS results and provide a roadmap for identifying and distinguishing each type of concentration effect.

Discovery & Development Drug Delivery

Overview of Key Principles of Dynamic Light Scattering to protein therapeutic formulations – Part 3

This four-part series examines common issues and questions surrounding the principles, measurements and analysis of DLS data and discusses how to minimize the time required for and increase the accuracy of acquiring and interpreting DLS data during the biotherapeutic development process. In Part Three, we cover the basic types of DLS deconvolution algorithms used to extract the intensity weighted particle size distribution from the measured correlogram.

Discovery & Development Drug Delivery

Overview of Key Principles of Dynamic Light Scattering to protein therapeutic formulations – Part 4

This four-part series examines common issues and questions surrounding the principles, measurements and analysis of DLS data and discusses how to minimize the time required for and increase the accuracy of acquiring and interpreting DLS data during the biotherapeutic development process. In Part Four, we address frequently asked questions related to the application of DLS to the characterization of protein therapeutic formulations.

Other issues of 2015