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August 2016 Issue of The Medicine Maker

Welcome to the July August issue. Upfront investigates how to make biopharma medicines on demand, a new method for targeting cancer, and the growth potential of China’s pharma market. In our cover feature, find out how the modern day cleanroom was invented and what new advances we might see in the future. Best Practice looks at how to use Six Sigma for Quality by Design, and NextGen celebrates the field of small-molecule drugs. We also sit down with Susanne Keitel, director of the EDQM.

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Articles featured in this issue

Manufacture Quality & Compliance

Turning Failure into Success

| Stephanie Sutton

We should look to Warning Letters – and the subsequent solutions – to benefit from the blunders of others.

Business & Regulation Business Practice

Made in China

| James Strachan

The world’s most populous state is set for big things in patented (bio) pharmaceutical development.

Discovery & Development Drug Delivery

Giving Cancer the Old One-Two

| James Strachan

Zap a tumor with radiation to trigger P-selectin expression, then release the drugloaded nanoparticles.

Manufacture Technology and Equipment

Tapping into Data Transparency

| James Strachan

A website exists to help researchers obtain clinical study data, but how useful is it?

Manufacture Technology and Equipment

Biopharma Battlefield

| James Strachan

Can portable kits manufacture on-demand biopharma medicines for remote soldiers?

Business & Regulation Business Practice

Too Close for Comfort?

| James Strachan

Researchers call for more oversight as some pharma companies cozy up to hemophilia patients.

Manufacture Facilities

Nominations for The Power List 2017

| Stephanie Sutton

Nominations for the 2017 Power List are now open and will close on February 1, 2017.

Manufacture Business Practice

The Innovation Awards 2016

| Stephanie Sutton

Nominations are open for The Medicine Maker 2016 Innovation Awards.

Business & Regulation Business Practice

Mylan’s Media Storm

| Stephanie Sutton

Mylan introduces new schemes to help tackle EpiPen costs for patients, as well as plans for a new direct-to-patient distribution model

Business & Regulation Business Practice

A Recipe for Brexit Success

| George Chressanthis

The pharma industry can succeed post-Brexit if the right policies are put in place.

Discovery & Development Drug Delivery

There Was Plenty of Room at the Bottom

| Merari Tumin Chevalier

What started as a vision of miniaturization is now beginning to have a profound influence on drug delivery.

Manufacture Technology and Equipment

Still Sieving...

|

Isn’t it time to move with the times and relegate manual and outdated processes?

Business & Regulation Facilities

Keep It Clean

| Stephanie Sutton

The technology behind cleanrooms is well over 50 years old. Is it time for a makeover?

Business & Regulation Facilities

Room For Improvement

| Brian G Hubka, Jeanne Moldenhauer

Today’s cleanrooms may meet current quality standards, but what about the future?

Manufacture Facilities

Top Cleanroom Advances

| Tim Sandle

Here, Tim Sandle gives a rundown of his top advances in cleanrooms in recent years.

Business & Regulation Quality & Compliance

Tackling Challenges and Change Together

| Susanne Keitel

The latest edition of the European Pharmacopoeia was published in July 2016 and some large changes are afoot.

Business & Regulation Quality & Compliance

Building a QbD Masterpiece with Six Sigma

| Jasmine

Many people struggle with QbD, but there are secrets to success…

Discovery & Development Drug Delivery

The Soft Side of Drug Delivery

| Keith Tanner

Tablets and capsules are often the “go-to” choice in oral drug delivery, but what about innovations other areas?

Discovery & Development Small Molecules

Small But Not Forgotten

Large molecules may grab the bulk of industry headlines, but small-molecule drugs are still pulling their weight.

Manufacture Business Practice

Raising Standards

| Susanne Keitel

Sitting Down With… Susanne Keitel, Director of the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe in Strasbourg, France.

Manufacture Business Practice

Viral Invaders

| Sponsored by Millipore Sigma

Protection at the genetic level – a new line of defense against contamination in biopharmaceutical manufacturing

Discovery & Development Business Practice

Gold therapy using dynamic light scattering

This article explains how dynamic light scattering (DLS) can be used to gather particle size distribution data for the successful use of nanosized colloidal gold in drug delivery applications.

Discovery & Development Business Practice

Combining spectroscopy: a new approach to meeting new pharmaceutical challenges

Automated image analysis has been combined with Raman spectroscopy to achieve component-specific size and shape analysis of active ingredients, supporting and accelerating the commercialization of both innovator and generic pharmaceutical products.

Discovery & Development Business Practice

Resonant mass measurement as an analytical tool

Predicting and measuring protein aggregation is a critical challenge in the formulation of biopharmaceuticals. This article describes an analytical tool that hits the ‘sweet spot’ of protein aggregation measurement

Other issues of 2016