The Growth Direct™ System leverages advanced imaging technology and industry leading automation to accelerate the analysis and enumeration of microbial samples in the manufacture of pharmaceuticals. The system provides results in about half the time of the traditional culture method. Sample preparation mirrors the existing method. Automated handling and analysis reduces hands-on time and potential manual errors, saving time and money while increasing lab productivity.
Rapid Micro Biosystems will be exhibiting at the PDA Annual Meeting in Scottsdale, Arizona on 16 -17 April. Visit their booth number 801 to hear some exciting news in the area of automated rapid microbial detection.
www.rapidmicrobio.com/blog
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Sanofi and Regeneron Pharmaceuticals, Inc. have announced that the FDA has granted Priority Review of the Biologics License Application (BLA) for the investigational agent Zaltrap® (aflibercept) concentrate for solution for infusion in combination with the irinotecan-fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-containing regimen...
Read the full story >>
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FDA approves Amyvid™
Amyvid is the first and only radioactive diagnostic agent approved for PET imaging of beta-amyloid neuritic plaques in the living brain...
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Efficacy and safety data for ZOSTAVAX®
Merck announced that data from the pivotal Phase III study with ZOSTAVAX® in adults ages 50 to 59 were published in the April 1 issue of Clinical Infectious Diseases...
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Conferences, events & exhibitions:
Development and Validation of Bioanalytical Assays for Biologics: Quantification (PK) and Immunogenicity Assays
12 - 13 April 2012, Dublin, Ireland
Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products
23 - 24 April, Berlin, Germany
Pharma QbD Forum
24 - 25 April 2012, Berlin, Germany
LogiPharma Europe
24 - 26 April 2012, Geneva, Switzerland
QA/QC Strategy for Biopharmaceuticals and Biologics
25 - 27 April 2012, Berlin, Germany
Austropharm
26 - 28 April 2012, Vienna, Austria
RNAi & Single Cell Biology-2012 Summit
1 - 2 May 2012, Waltham, USA
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