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May 2015 Issue of The Medicine Maker

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Articles featured in this issue

Business & Regulation Business Practice

Destination: Innovation

| Charlotte Barker

Tell us about the 2015 breakthrough products that are shaping the way you work

Manufacture Biosimilars

Biosimilar Buzz

| Stephanie Sutton

Regulators and manufacturers are readying for the opening of the US market, but legal wrangles continue to block the way

Discovery & Development Drug Delivery

Hitting the Bullseye

| Stephanie Sutton

Exosomes help deliver drug into the heart of the tumor

Manufacture Biosimilars

FDA Ups Generics Oversight

| Charlotte Barker

A US government study reports progress – but also highlights shortfalls

Discovery & Development Analytical Science

Fingerprinting mAbs

| Stephanie Sutton

Scientists find a way to ‘fingerprint’ the structure of a monoclonal antibody

Manufacture Quality & Compliance

Mind the Gap

| Stephanie Sutton

Some drug shortage prevention plans fail, while others succeed. Why? ISPE helps companies find the answer

Manufacture Advanced Medicine

Public Perceptions

| Stephanie Sutton

How much do the public really know about pharma R&D?

Manufacture Drug Delivery

Click and Connect

Click chemistry creates biocompatible hydrogels for drug delivery and tissue engineering

Manufacture Biosimilars

Biosimilars: the Big Picture

| Joshua Cohen

In the midst of wrangles over biosimilars naming and interchangeability, let’s not forget the key benefit – putting the brakes on the growth in biologics expenditure.

Manufacture Facilities

Fill & Finish of the Future

| Susan Dexter

The technology has barely changed over the last 30 years – surely, it’s time for some long overdue innovation.

Manufacture Business Practice

Wake Up to Smart Serialization

When it comes to anti-counterfeiting, you need to go beyond legislation, think ahead, and harness the competitive edge that serialization can offer.

Discovery & Development Ingredients

Three Gurus of HPAPI Hazards

| Charlotte Barker

We bring together three experts to discuss how we can protect medicine makers in a world of increasingly powerful drugs.

Discovery & Development Small Molecules

Rising DAMPP

| Laura J. Hirshfield, Elçin Içten, Arun Giridhar

With the introduction of Process Analytical Technology and Quality by Design, the pharmaceutical industry has been looking towards innovative manufacturing methods to consistently and accurately deliver quality products

Business & Regulation Biosimilars

Keeping a Finger on the Biosimilar Pulse

| Fiona Greer

The rise of biosimilars is great news for overburdened healthcare systems, but it’s a very different proposition to a simple generic. Here, I discuss some of the many challenges – legal, regulatory, non-clinical and clinical – that manufacturers face when developing biosimilar products for global markets.

Business & Regulation Business Practice

Freedom Fighter

| Charlotte Barker

Sitting Down With… David Pyott, Former Chairman of the Board and Chief Executive Officer of Allergan, Inc.

Discovery & Development Drug Delivery

Delivering Change

| Sponsored by Catalent

Alternative delivery routes for large-molecule drugs are sorely needed – could a new consortium lead the way?

Discovery & Development Clinical Trials

The big reveal: Workhorse + Innovation = more information (Part 2)

In this second article of a short series Dr Paul Kippax is looking at how recent innovations are substantially enhancing the value and informational productivity of some of our established and trusted analytical techniques. This time, the addition of multiple detectors to a GPC/SEC analysis…

Manufacture Ingredients

The big reveal: Workhorse + Innovation = more information

In this short series of articles, Dr Paul Kippax is looking at how recent innovations are substantially enhancing the value and informational productivity of some of our established and trusted analytical techniques. This time, the addition of Raman spectroscopy to automated imaging…

Discovery & Development Business Practice

Analytical techniques with a place in the oral solid dosage formulation toolkit

In this article we look at the steps involved in moving from a drug substance to a successful oral solid dosage (OSD) form, and at the analytical technologies that can be helpful. In particular, we focus on gathering the required information to progress pharmaceutical development within the context of the regulatory requirements and the application of QbD.

Other issues of 2015