Pharmaceutical Technology Europe, Apr 1, 2010 - Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

Pharmaceutical Technology Europe, Apr 1, 2010
Special Feature
The personalized medicine marathon
Although holding great potential medical advances, personalised medicine will not come to fruition overnight and business models will require long-term strategies and great flexibility.
Science alone will not lead to better medicines
Pharmaceutical Technology Europe interviews Edward Abrahams PhD, Executive Director of the Personalised Medicine Coalition.
Overcoming manufacturing and financial challenges of personalized cell therapies
Person-specific cell therapy could potentially offer a cure as opposed to ongoing treatment, but it is also a disruptive technology that doesn't currently fit into traditional therapeutic manufacturing processes.
The current and future market for SNPs
Single nucleotide polymorphisms (SNPs) are responsible for more than 80% of the variations between individuals, and are present throughout most genes and other important sequences in the human body, which makes them ideal for tracking down correlations between genotype and phenotype.
Personalizing cancer therapy
We have recently launched a novel personalised therapy clinical trial to treat patients with late-stage colorectal cancer at George Mason University's Center for Applied Proteomics and Molecular Medicine (CAPMM). This is one of the most cutting-edge personalised therapy clinical trials in the world for several reasons including
Analytical Testing
Reduced method robustness testing of analytical methods driven by a risk-based approach
By Phil Borman , Marion Chatfield , Patrick Jackson , Alice Laures , George Okafo
A novel approach for assessing method robustness is described that uses risk-based assessment tools to identify, score, prioritise and then group method parameters.
Ask the Expert
Choosing a spectroscopic system for tablet analysis
By Janie Dubois
Vibrational spectroscopy, which encompasses near-infrared, mid-infrared and Raman spectroscopy, is an important analytical tool in the pharma industry.
Manufacturing
Quality management systems for small organizations: Reducing the headache
By Graham Clapperton , Michael Gamlen
Many small pharma/biopharma companies do not understand what a QMS is and the benefits offered by such a system. To be effective, there are several key strategic elements and systems that a QMS must incorporate.
Spotlight
The changing face of European regulatory affairs
By Faiz Kermani
In 1995, pharmaceutical regulation in Europe underwent a dramatic change with the emergence of the European Medicines Agency. The agency's 15-year history has been eventful, with it having to adapt to a changing regulatory landscape and new expectations from those relying on it for guidance.
News
Can new vaccine manufacture method cut time to market by half?
Could insect cells offer a faster way of manufacturing pandemic influenza vaccines compared with traditional egg-based methods? According to researchers at the Vienna Institute of BioTechnology (Austria), their new technique could help a virus-like particle (VLP) vaccine to reach the market within 3 months from the first isolation of a new influenza strain — traditionally produced vaccines take approximately 6 months.
Editor's Comment
The sky's the limit
By Fedra Pavlou
Change is a part of life which some fear whilst others thrive. In the commercial world, a fundamental aspect of good management is to apply strategic insight to react to change in order to survive and grow. The pharmaceutical industry, as with every industry, is constantly exposed to new threats. Companies are all too painfully aware that the external threats that it currently faces, as well as the threat of their own drying pipelines, are forcing it to adapt and to stay on the lookout for new opportunities — now more than ever.

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Which of the following business challenge poses the greatest threat to your company?
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Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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