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December 2016 Issue of The Medicine Maker

Welcome to the December issue. Upfront investigates the fate of the EMA’s headquarters after Brexit, a ‘number one’ mystery and ultra-long acting drug delivery. Our cover feature, celebrates the most exciting drug development and manufacturing technologies released during 2016.
NextGen asks what ISPE’s 2016 Facility of the Year Awards tell us about the future direction of
the industry, and in Best Practice, Jasmine explains why multivariate statistical modeling can play a key role in Quality by Design. We also sit down with Jayasree K. Iyer, Executive Director of the Access to Medicine Foundation.

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Articles featured in this issue

Business & Regulation Business Practice

Ending 2016 with Storms and Celebrations

| Stephanie Vine

A storm around drug pricing is building for 2017, but it shouldn’t overshadow the great and good.

Manufacture Drug Delivery

Star Treatment

| James Strachan

Could star-shaped drug delivery capsules be the solution for ultra-long acting delivery?

Business & Regulation Standards & Regulation

Safe Passage for Cures

| James Strachan

The 21st Century Cures Act is passed through US Congress – and includes big plans for the FDA.

Discovery & Development Standards & Regulation

CAR-T Tragedy

| James Strachan

More deaths in a cancer immunotherapy trial raise questions over CAR-T safety

Business & Regulation Business Practice

The Power is Close at Hand

| James Strachan

Nominations are open for the 2017 Power List, but will close in February 2017.

Manufacture Small Molecules

Number One Mystery

| James Strachan

How pungent camel urine could lead to new treatments for African sleeping sickness.

Business & Regulation Business Practice

Location, Location, Location

| James Strachan

An EMA task force prepares for the worst should the Agency's HQ be affected by Brexit.

Manufacture Biosimilars

Why Share Your Biosimilars Cake?

| Guillaume Plane

Biosimilar drugmakers should remember that the best cake is one that doesn't have to be shared.

Manufacture Facilities

Finding a Fumigant

| Andrew Ramage

Formaldehyde’s days as a fumigant are numbered, but choosing an alternative isn’t easy.

Discovery & Development Analytical Science

Finding Fakes

| Ravi Kalyanaraman

Looking at the past, present and future of counterfeit drugs screening.

Manufacture Technology and Equipment

Innovation Returns

| Stephanie Vine

The Medicine Maker Innovation Awards are back for the second year to show case the top tech of 2016.

Manufacture Technology and Equipment

Words Of A Winner

One year on from winning our inaugural Innovation Awards, we caught up with Niclas Nilsson

Manufacture Business Practice

Facility Innovation by Design

| Stephanie Vine

What do ISPE’s 2016 Facility of the Year Awards tell us about the future direction of the industry?

Manufacture Advanced Medicine

Riding the Cell Therapy Wave

A surge of exciting new cell-based treatments is coming – but is the industry ready?

Manufacture Quality & Compliance

Time to Dive into Design of Experiments

| Jasmine

Data, data everywhere… But pharma is not making the most out of it.

Business & Regulation Business Practice

Accessing Big Pharma’s Conscience

| Jayasree K. Iyer

Sitting Down With... Jayasree K. Iyer, Executive Director, Access to Medicine Foundation

Discovery & Development Business Practice

In Conversation with Matthias Bucerius of Merck KGaA at CPhI Worldwide 2016

The Medicine Maker's Charlotte Barker speaks with Dr Matthias Bucerius from Merck KGaA

Discovery & Development Business Practice

In Conversation with Andreas Gryczke of BASF at CPhI Worldwide 2016

The Medicine Maker's Charlotte Barker speaks with Andreas Gryczke from BASF

Discovery & Development Business Practice

In Conversation with Franco Negron of Patheon at CPhI Worldwide 2016

The Medicine Maker's Charlotte Barker speaks with Franco Negron from Patheon

Discovery & Development Business Practice

Dry Powder Inhaler Formulation Development

Dry powder inhalers are accepted as being complex drug products due to the interactions which occur between the active pharmaceutical ingredients (APIs) and excipients within the formulation and the way this then affects the efficiency of drug delivery by the inhaler device. Obtaining component specific particle size and particle shape distribution data can help with understanding the properties of the formulation as part of formulation or deformulation studies. This application note describes how the combination of automated image analysis with Raman spectroscopy in the Morphologi G3-ID allows the individual components present within a dry powder inhaler formulations to be independently characterized and compared.

Discovery & Development Business Practice

Top five reasons to replace a viscometer with a rheometer

Is your viscometer approaching the end of its life? Are you starting to feel that your trial and error, ‘rheology-light’ approach to formulation is becoming dated? Or are there longstanding product performance issues that you’re failing to gain traction with, where you suspect rheology may hold the answer? 

Discovery & Development Business Practice

In-vitro bioequivalence studies

The Morphologi G3-ID can be used to compare the Active Pharmaceutical Ingredients (API) within oral solid dose formualtions. Here we apply it to comparing innovator and generic versions of a product containing two APIs.

Manufacture Business Practice

Direct visualization, sizing and concentration measurements of drug delivery nanoparticles

In this application note, we discuss how Nanoparticle Tracking Analysis (NTA) is used to measure the size and concentration of nanoparticles used for drug delivery, such as liposomes, in order to determine efficacy and rate of uptake, degradation and clearance from the body.

Other issues of 2016