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March 2016 Issue of The Medicine Maker

In this issue, our upfront topics range from a fighting flu with imitation antibodies, to pharma cargo stolen by the Italian mafia. Our feature discusses LEO Pharma’s Open Innovation platform – the winner of our Innovation Awards. In best practice, four scientists tell us how new spectroscopic sensors can streamline bioprocess monitoring to better meet FDA standards. In NextGen, we speak with John Salafsky about a new technique to see protein conformational changes in real time, which could open up new screening options for drug discovery; and we Sit Down With Keith Thompson, CEO of the Cell and Gene Therapy Catapult, UK.

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Articles featured in this issue

Business & Regulation Business Practice

Open or Closed Innovation

| Stephanie Sutton

Collaboration can be the key to success, but does open innovation truly unlock the right doors?

Manufacture Quality & Compliance

Vendors Reloaded

Medicine packaging leaders forming the “Matrix Alliance” will bring improved container and closure systems to market.

Manufacture

Fighting Flu with Imitation Antibodies

Scientists use computationally designed imitation antibodies to fight the flu – and production costs.

Business & Regulation Business Practice

Pharma Thieves

A new study estimates that 11.6 billion euros’ worth of goods are being stolen across Europe each year – but what about pharmaceuticals?

Business & Regulation Standards & Regulation

A New Administration

Despite controversies, Robert Califf will finally take the reins at the FDA.

Discovery & Development Drug Delivery

Elimination by Illumination

Could light-activated quantum dots put the “antibiotic apocalypse” on hold?

Discovery & Development Packaging

Breaking Glass

| Holger Krenz

Glass is the most important primary packaging material for injectable drugs, but the demanding requirements of today’s sensitive biologicals mean that we must consider newer, safer alternatives.

Discovery & Development Drug Delivery

Surveying the New World of Drug Delivery

| Karan Verma

The drug delivery field may be about to see dramatic shifts in accepted modalities. Nanoparticles, targeted delivery systems and a move from oral to transdermal routes will all play a part in tomorrow’s drug delivery landscape.

Manufacture Small Molecules

The Case for Continuous

| Reiner Lemperle

“Batch is best,” according to many in the industry, but when cost reductions and greater efficiencies are a priority, continuous processing is becoming increasingly compelling.

Discovery & Development Business Practice

The Bright Star of Open Innovation

| Niclas Nilsson

Pharma companies are notoriously protective of their intellectual property, so it’s a big deal to open up and give knowledge away for free. Nevertheless, it is the path that LEO Pharma took with its Open Innovation platform – and they’ve learnt that, if you give a little away, you can expect much in return.

Discovery & Development

The Shape of Proteins to Come

A new technique allows scientists to see conformational changes caused by ligand binding in real time, opening up new screening options for drug discovery.

Manufacture Analytical Science

Not Spoiling the (Biopharma) Broth

| Dörte Solle, Philipp Biechele, Christoph Busse and Thomas Scheper

Can sophisticated (spectroscopic) sensors streamline bioprocess monitoring to better meet FDA standards?

Manufacture Analytical Science

From UV to MIR: the biomass monitoring spectrum

| Dörte Solle, Philipp Biechele, Christoph Busse and Thomas Scheper

Can sophisticated (spectroscopic) sensors streamline bioprocess monitoring to better meet FDA standards?

Manufacture Facilities

Fumigation of the Future

| Andrew Ramage

A choice of fumigants are available for fumigating microbiological safety cabinets and high-level containment rooms. One substance that is still used in the industry is formaldehyde, but given that formaldehyde is toxic, carcinogenic and corrosive, you’d be better looking for alternatives.

Discovery & Development Business Practice

The Numbers Game

Statisticians are vital in the pharma industry, but rarely do they receive public fanfare for their work. The Award for Statistical Excellence in the Pharmaceutical Industry aims to change the status quo.

Manufacture Business Practice

Catapulted to the Top

Sitting Down With... Keith Thompson, CEO of the Cell and Gene Therapy Catapult, UK.

Discovery & Development Drug Delivery

Micro-Formulating for Dermal Drug Delivery

| Sponsored by BASF

Industry is beginning to appreciate how formulation microstructure makes a fundamental contribution to dermal drug delivery – and this new understanding emphasizes the key role of excipients.

Manufacture Business Practice

BioProcess Insights

| Sponsored by GE Healthcare

A collection of articles examining the trends and challenges of bioprocessing

Manufacture Drug Delivery

Ready to Break the Mold?

| Sponsored by Schott

Pharma suppliers are teaming up to take ready-to-use technology to the next level.

Discovery & Development Analytical Science

Biopharmaceuticals are complex; analyzing them just got a lot easier

Great technology takes complex challenges and provides simple, robust solutions.

Discovery & Development Analytical Science

Biotherapeutic Protein Characterization Challenges: The NIBRT Perspective

NIBRT Principle Investigator Jonathan Bones discusses the challenges involved in biotherapeutic protein characterization.

Discovery & Development Analytical Science

Biopharmaceutical characterization demands advanced detection capabilities

Innovation that takes technology design to the physical limits

Discovery & Development Business Practice

Reverse engineering of a pharmaceutical formulation

The Morphologi G3-ID can be used to generate component-specific particle size and shape data required to aid the reverse engineering of solid oral dose formulations. Here, we provide an example case study for a powder formulation.

Discovery & Development Business Practice

Accelerate liquid formulation development for protein biopharmaceuticals

The work presented here illustrates how Differential Scanning Calorimetry (DSC) is used in the early stages of protein characterization to rapidly provide critical data about protein stability that can be used as a guide to support and accelerate liquid formulation.

Discovery & Development Biosimilars

Taylor Dispersion Analysis explained

Taylor Dispersion Analysis is an ultra-low volume, microcapillary flow technique for sizing and stability of biomolecules in complex solutions, and offers advantages for orthogonal and complementary biophysical characterization measurements.

Other issues of 2016