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  Pharmaceutical Technology Europe E-Alert
 
17 February 2015
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Featured Content
Developing and Validating Assays for Small-Molecule Biomarkers
Working with biological matrices and understanding the intended use are crucial. More...
 
Enhancing Dissolution of Poorly Soluble Drugs through Jet-Milling
The authors discuss a novel particle engineering technology based on mechano-chemical activation. More...
 
Special Considerations for Extractables and Leachables Testing in Biological Products
New guidelines focused on the materials of construction in biologic therapy packaging will help vendors prepare comprehensive extractable and leachable testing strategies. More...
 
Top Stories
FDA After Hamburg
The industry reacts to the departure of Commissioner Margaret Hamburg. More...
 
Genzyme Announces $845-Million Gene Therapy Deal
Genzyme will partner with Voyager Therapeutics for the discovery, development, and commercialization of novel gene therapies for central nervous system disorders. More...
 
Industry News
Pfenex Announces Partnership with Hospira to Develop Lucentis Biosimilar
Pfenex announced that it entered into an agreement to partner with Hospira on the development and commercialization of PF582, a biosimilar candidate to Lucentis. More...
 
CDER and Biotech Quality Assessment
The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality. More...
 
FDA Approves Lucentis for Diabetic Retinopathy
FDA has approved Genetech's Lucentis to treat retinopathy in patients with diabetic macular edema. More...
 
FDA Releases Guidance Documents on Risk Information and IND Applications
The agency releases guidance documents on Individual Patient Expanded Access Applications and disclosing risk information to patients. More...
 
Webcasts
Pharma Supply Chain Security: Are You in Control?
February 25, 2015 at 11AM ET
Sponsored by Spectrum Chemical Mfg. Corp.
 
Fundamentals of Spray-Dried Dispersion Technology
March 19, 2015 at 11AM ET
Sponsored by Bend Research
 
More Webcasts

Product/Service Profile
Catalent
Catalent provides end-to-end solutions to accelerate drug development programmes and with the addition of Micron Technologies' particle size engineering capabilities, now has the broadest bioavailability solutions toolkit in the industry.
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Shimadzu
Universal solution for automated HPLC method development
Shimadzu's Nexera Method Scouting system provides an outstanding platform for efficient HPLC method development and implementation. It is based on the Nexera X2 next-generation ultra-high performance liquid chromatograph, an all-round LC system for ultra-high-speed analysis.
Read more

Reference Library

Pharmaceutical Technology presents its Analytical Testing Resource Guide combo
A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products. ... Click here
2015 Biopharmaceutical Benchmarking Survey

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• Receive a free summary of the results.
• And more

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