October 2015 Issue of The Medicine Maker

Mislabeled, substandard or falsified medicines are the perfect opportunity for criminals looking for low risks and high rewards.

Expedited regulatory approvals bring medicines to market faster – but are they the right drugs?

Genome mining hunts for bacteria micro-chemists that could help develop innovative drugs.

A digital pill submitted for regulatory approval tells caregivers if you’ve taken your medicine

Researchers redesign existing drugs to be more biodegradable and environmentally friendly.

As the industry makes its video game debut, the big question is: will you prioritize patients over profit? Here’s our big review.

The EMA fights to reinstate its former executive director – and the FDA’s new leader is still unconfirmed

Clinical development is outmoded; we are witnessing serious attrition in cancer R&D. Perhaps it’s time to live and die by the mantra: “no biomarker, no trial”.

When seeking to measure quality across an organization, what is the right approach?

Microbiological approaches are faster and more advanced than ever before – so why on earth isn’t the pharma industry using them?

Regulators are driving serialization and tamper-evident packaging initiatives, but is the pharma industry fully primed to defend against counterfeits?

Recently, Tim Mackey and colleagues examined the extent to which counterfeit drugs had penetrated global legitimate supply chains.

Grant Lindman is director of Eli Lilly’s global anticounterfeiting operations and is passionate about fighting fake medicines.

Track and trace is often used on pharmaceutical packaging but what if an invisible code could be applied directly to a tablet?

Single-use technology is ready to lend a helping hand to biomanufacturing, but is the industry ready to turn away from stainless steel?

Personalized cell-based therapies have been hyped as the future of medicine, but are current manufacturing technologies up to the task?

How can the pharma industry capitalize on the growth potential of emerging markets?

Sitting Down With... John Talley, Chief Scientific Officer at Euclises Pharmaceuticals, St. Louis, USA.

Lawrence (Larry) Lesko is a bioanalytical veteran with many years of academic and FDA experience under his belt.

There are many hurdles in drug development, but your chances of success increase significantly if you pay more attention to API optimization from the outset.

Ronan Daly describes his research in combining inkjet printing and medicines.

Javier Morales tells us why he is investigating inkjet printing for the development of buccal films for the delivery of biologic drugs.

This application note describes how and when can kinetic information be retrieved from ITC power curves.

Two antibody samples were characterized using column calibration and multi-detection SEC, and the results compared...

Use of a novel combination of dynamic light scattering and Raman spectroscopy to elucidate the conformational stability and structure of proteins in biopharmaceutical formulations

In Part One, we provide an overview of the key principles of DLS: theory, correlation statistics, deconvolution algorithms, and the intensity to mass transform.

In Part Two, we cover the influence of concentration effects and particle interactions on DLS results and provide a roadmap for identifying and distinguishing each type of concentration effect.

In Part Three, we cover the basic types of DLS deconvolution algorithms used to extract the intensity weighted particle size distribution from the measured correlogram.

In Part Four, we address frequently asked questions related to the application of DLS to the characterization of protein therapeutic formulations.