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Pharmaceutical Technology Europe E-Alert

12 March 2010

IN THIS ISSUE
• PTE Digital March issue
• Lyophilisation challenges
• Thermal fingerprinting
• Lyophilisation products
• More...



Focus on freeze drying The March issue of PTE's monthly digital magazine examines the challenges and trends in lyophilisation, and looks at some of the key innovations taking place in this sector. More...

Challenges and trends in lyophilisation 'Lyophilisation' literally means to make a substance 'solvent-liking; however, the purpose of lyophilisation is not always to improve the dissolution of poorly soluble compounds. More...

Thermal fingerprinting: a way to optimise lyophilisation A consistently reliable freeze drying protocol can be established by using a concept called 'thermal fingerprinting'. More...

Lyophilisaton product showcase A range of some of the top lyophilisation technologies available on the European market. More...

Pharmaceutical safety programme launched A UK consortium has completed pilot runs of a pharmaceutical safety programme that uses electronic tracking and authentication to ensure the safety of drugs in the supply chain. More...

FDA issues guidance for cell-based viral vaccines The FDA has published guidance for the characterization and qualification of cell substrates, viral seeds and other biological materials used to manufacture viral vaccines for human use. More...

PhRMA seeks policy changes to proposed Russian pharmaceutical law The Pharmaceutical Research and Manufacturers of America (PhRMA), along with eight other pharmaceutical, business and trade organizations, are calling on Russian authorities to consider policy changes as they relate to clinical trial regulation and intellectual property to draft legislation in Russia, the Draft Law on the Circulation of Medicines. More...

Rheumatoid arthritis treatment suspended Following a number of serious adverse events, including infections and fatalities, Roche and Biogen Idec have suspended the late-stage development of ocrelizumab for the treatment of rheumatoid arthritis (RA). More...

Product Profile

Center for Professional Advancement

Access Training You Need Now

Listen to this podcast recorded live from the show floor of AAPS 2009. Clinical development is key for new drugs. In order to minimize risks and take advantage of opportunities, you need comprehensive know-how and years of experience. Vetter, as a specialist in the aseptic filling of injection systems, will provide with its new facility the manufacturing of preclinical, Phase I and Phase II clinical batches in Chicago. We invite you to find out more about Vetter Development Services USA Inc.

Starna

An easy to handle non-consumable photometric linearity Certified Reference Material (CRM) set has been introduced by Starna Scientific which uses propyl parabenz in methanol to qualify photometric linearity in UV diode array based HPLC systems.

FDA increased its budget by 19% between FY 2009 and FY 2010, and has asked for another 23% increase for FY 2011. Has the agency asked for too much or too little?

■		Asking for exactly what it needs 32%
■		Underestimating the funding it needs 40%
■		Overstepping its reach in asking for too much 28%

This week we would like to know...

When sourcing raw materials and non-GMP intermediates or other chemicals, where are the majority of your suppliers located?

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