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December 2015 Issue of The Medicine Maker

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Articles featured in this issue

Manufacture Technology and Equipment

New and Improved

| Charlotte Barker

New technologies in our Innovation Awards… and an expanded editorial team!

Manufacture Analytical Science

Smart Sensor Capsule

| Stephanie Sutton

A capsule being developed in Ireland aims to contain not medicine, but process analytical technology

Discovery & Development Drug Delivery

New Age Traveler

From Iceland’s volcanic springs to a lab in South Denmark; does the microbe Sulfolobus. islandicus hold the key to a drug’s safe transit through the gut?

Business & Regulation Business Practice

A Turbulent Transaction?

Pfizer and Allergan are to combine to form the world’s biggest pharma behemoth – but much attention has focused on the tax implications

Manufacture Advanced Medicine

Let Construction Commence for Cell Manufacture

The UK aims high with a new manufacturing center designed to meet the needs of cell and gene therapies

Business & Regulation Business Practice

AMA Ad-Block

The AMA calls for a ban on direct-to-consumer drug advertising in the US. But is such prohibition realistic?

Manufacture Advanced Medicine

Bridging the 'Omics Gap

A new personalized test aims to predict side effects

Business & Regulation Business Practice

An Issue of Quality

| Stephanie Sutton

2015 has been a difficult year for Indian pharma companies – and ASSOCHAM is calling for the country to get its “house in order”.

Discovery & Development Analytical Science

Data: Wanted Dead or Alive

| Ryan Sasaki

Can R&D organizations really afford to kill off analytical data that could be used for future decision-making?

Business & Regulation Business Practice

A Dangerous Trend?

The reverse merger between Pfizer and Allergan is the most recent chapter in a decades-long transformation of the pharma industry, but I believe it also represents a rapid acceleration of a troubling trend.

Business & Regulation Business Practice


The Ebola epidemic spurred a tremendous amount of R&D in search of vaccines and treatments – and yet it was a relatively low impact global emergency compared with malaria.

Discovery & Development Standards & Regulation

Understanding Acceptable – Analytical Method – Submissions

| Marie Morin

Digesting regulatory guidance is not always easy, but understanding the main points – and then paying attention to the details – will improve your chances of success.

Manufacture Technology and Equipment

The Medicine Maker Innovation Awards

| Stephanie Sutton

Welcome to The Medicine Maker inaugural Innovation Awards; recognizing the most exciting new technologies of 2015!

Business & Regulation Business Practice

How to Get PR Right

| Marcus Lippold

How do your customers, your competitors, the press or even the public perceive your organization?

Manufacture Small Molecules

Precision Medicine; Imprecise Manufacturing and Supply

Precision medicine holds much promise, but there’s no question that it will disrupt current manufacturing and downstream supply chain habits.

Business & Regulation Business Practice

Emerging Market Explorer

Sitting Down With... Raman Singh, President, Mundipharma Asia Pacific, Latin America, Middle East and Africa.

Manufacture Bioprocessing - Upstream & Downstream

Making Media Better Than Average

| Sponsored by GE Healthcare

Cell culture media developers used to focus on maximizing protein yield. But yields are yesterday’s problem

Manufacture Analytical Science

Piecing Together Protein Analysis

| Sponsored by ThermoFisher Scientific

When it comes to biosimilar development, companies must thoroughly characterize both the originator and the new candidate to demonstrate biosimilarity.

Manufacture Drug Delivery

Sublingual Vaccines – A Taste of the Future?

| Sponsored by Catalent

It is well known that small molecules can be formulated in rapidly dispersing, dissolve-in-the-mouth tablets. But what if biologics and vaccines could also be delivered via the buccal or sublingual route?

Manufacture Business Practice

Binding thermodynamics of substituted diaminopyrimidine renin inhibitors

See how thermodynamics can be used to improve your lead optimization process. The current work has shown that a combination of library screening, molecular modeling, analysis of structural, thermodynamic, and inhibition data provided a valuable tool for structure based drug design. Even when structural data are not available, thermodynamic data can provide insight into drug design but interpretation of thermodynamic data is more insightful when structural data are available. Some insight into drug design that thermodynamic data provide is intuitive to skilled medicinal chemists, but there are situations that are not apparent without thermodynamic measurements. This work used a combination of structural, thermodynamic, and inhibition data to design unique potent small molecule inhibitors of renin.

Manufacture Business Practice

Using Differential Scanning Calorimetry (DSC) to optimize antibody manufacturing

In this white paper, based on a recent presentation by Genzyme scientists, we report the use of the thermal stability data obtained from DSC to screen conditions for viral inactivation of an antibody1. This information provides a quick and easy stability assay during the manufacturing process. For the antibody studied here, the apparent Tm data from DSC was key to the recommendation to increase storage pH immediately after viral inactivation, resulting in increased structural stability. This example illustrates the crucial role of DSC and thermodynamic analysis during therapeutic protein development.

Discovery & Development Business Practice

Measuring Low-Level Polymorphic Contamination using Morphologically Directed Raman Spectroscopy

Polymorphic conversions are an ongoing problem in the pharmaceutical industry. Here we describe the use of Morphologically-Directed Raman Spectroscopy to distinguish and quantify particles of different polymorphic types of acetaminophen (paracetamol) within a mixture. MDRS is a flexible tool for root cause analysis, product quality and formulation development and is well-suited to identifying even low-level polymorphic contamination.

Other issues of 2015