June 2016 Issue of The Medicine Maker

Cell therapy successes are widely hailed as breakthroughs, but will adverse effects and patient deaths hold the field back?

Tumor cells and phages inspire a new drug delivery method targeting the placenta

A survey-based report highlights wildly inaccurate drug demand projections

The EMA says it will review its standards for first-in-human trials

How difficult is it to develop a new drug? Statistics have the answer

Will expanding the Priority Review Voucher scheme defeat its original purpose?

Will future drugs in Europe be priced based on therapeutic outcomes?

The UK votes to leave the European Union: what happens next, and what are the implications for pharma?

A video game built about the pharma industry adds marketing and malpractice capabilities

Amazing innovation is happening all around us in the pharma industry. We should take the time to look outside of our own unique areas to congratulate the efforts of others.

Europe has set the stage for safer supply chains with its Falsified Medicines Directive. Next, the spotlight could fall on using serialization to boost patient centricity.

Decisions around toxicology testing must be made using scientific methods, not emotions or politics.

When an industry grows rapidly, innovative approaches are required to ensure sustainable growth. Here, we speak to leaders at Ireland’s National Institute for Bioprocess Research and Training – NIBRT – to find out how a focus on talent, training and technology is changing the face of the field.

When an industry grows rapidly, innovative approaches are required to ensure sustainable growth. Here, we speak to leaders at Ireland’s National Institute for Bioprocess Research and Training – NIBRT – to find out how a focus on talent, training and technology is changing the face of the field.

When an industry grows rapidly, innovative approaches are required to ensure sustainable growth. Here, we speak to leaders at Ireland’s National Institute for Bioprocess Research and Training – NIBRT – to find out how a focus on talent, training and technology is changing the face of the field.

When an industry grows rapidly, innovative approaches are required to ensure sustainable growth. Here, we speak to leaders at Ireland’s National Institute for Bioprocess Research and Training – NIBRT – to find out how a focus on talent, training and technology is changing the face of the field.

Ireland can boast of many success stories when it comes to biopharma investment. Here, Barry Heavey from IDA takes us on a tour of recent investments and explains why talent and training are key.

Packaging components can leach into drug products and become foreign impurities. Guidelines exist for the testing of drug products for elemental impurities, but how are these applied to elemental impurities derived from drug product packaging?

After finally breaking into the US market, biosimilars have created a real buzz in the industry, but the best practice for demonstrating similarity can be daunting to say the least.

Mobile technology and apps have become a staple of the pharma industry in terms of disseminating information to patients. Much less is known about their impact on manufacturing, but thanks to developments in cloud computing, the sky’s the limit.

Sitting Down With... Ibraheem “Ibs” Mahmood, President and Chief Executive Officer, DrugDev, founded in the UK and headquartered in King of Prussia, PA, USA.

Manufacturers have gotten to grips with the complexities of batch-based bioprocesses, but breaking into the realm of continuous bioprocessing can lead to even greater efficiency.

Few oral biologics have made it to market, and though the challenges are well known, the benefits are huge and the task is not impossible. New technologies can help.

When it comes to film coating, there’s more than meets the eye. Is the drug or tablet core sensitive to acidity or moisture? What release profile is needed? And finally, how will the patient react to the finished product?

In this application note we describe the use of Nanoparticle Tracking Analysis (NTA) for size and concentration measurements of drug delivery nanoparticles. In addition, by using a fluorescently tagged drug molecule, it was possible to determine how many drug delivery nanoparticles had successfully been loaded with drug molecules.

Measurement and characterization of binding interactions between proteins and low-molecular weight (LMW) ligands are a focus of academic research and drug discovery. Isothermal titration calorimetry directly measures heat released or absorbed in a binding event, providing means for studying protein-small molecule interactions in solution without the need for labeling or immobilization. Importantly, ITC is often utilized to characterize differences in entropic and enthalpic contributions to binding of novel ligands.

High concentration, low-viscosity, stable therapeutic protein formulations are needed to enable low-volume parental administration. This article explores how a fully automated light scattering system supports the rapid screening of small volume samples in well plates for the rapid identification of suitable biologics during early phase development.

OMNISEC measures the Critical Quality Attributes of polymeric pharmaceutical excipients with unrivalled sensitivity supporting their efficient use to formulate safe and effective pharmaceutical products.

Particle agglomeration can compromise the clinical efficacy of pharmaceutical products and must therefore be closely controlled. This article provides practical guidance on using automated imaging for efficient agglomerate detection.

Which equipment can measure how the particle size delivered by a dry powder inhaler (DPI) changes as a function of applied air flow rate, providing a deagglomeration profile which can be used to compare the performance of different formulations in a device and improve drug delivery.