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Podcasts

Webcast: The Basics of Biosafety Testing for Biologics (May 21)
Sponsored by SGS

Webcast: Minimizing Out-of-Specification (OOS) Errors Using a Risk-based Gravimetric Approach (May 22)
Sponsored by Mettler-Toledo

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Events

World Biotechnology Congress 2013
June 3-6, 2013
Boston, USA

Late Stage Pharma Lifecycle Management
June 4-5, 2013
Brussels, Belgium

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Podcasts
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Pharmaceutical Technology Solid Dosage Combo
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May 16, 2013 PharmTech.com PRINT SUBSCRIBE DIGITAL SUBSCRIBE



News

Big Pharma’s Manufacturing Investments in Biologics
Despite overall manufacturing rationalization in the pharmaceutical/biopharmaceutical industry, the large pharmaceutical companies continue to invest in biologic-based manufacturing.
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An Integrated Prefilled Syringe Platform Approach for Vaccine Development
The authors describe a holistic and integrated approach to focus on the linkage of the prefilled syringe with the four phases of product design, development, operation, and control.
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Risk Mitigation and Microbial Control and Monitoring of Cleanrooms
A control strategy can maintain a low level of particulates, and thereby a low bioburden, in cleanrooms.
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FREE WHITEPAPER: The Key to Tableting Success
Learn about common pitfalls, critical questions to ask your tooling provider, and the basics of tool steel selection. Learn More!


News

USP Launches Initiative to Fight Counterfeit Drugs in Sub-Saharan Africa
New Center for Pharmaceutical Advancement and Training increases number of experts and available tools in Sub-Saharan countries.
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Lilly’s Enzastaurin Disappoints in Phase III Trial
Eli Lilly reported that enzastaurin did not meet the primary endpoint in a Phase III study, which evaluated the agent as a monotherapy for the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL).
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Minimizing Out-of-Specification (OOS) Errors Using a Risk-based Gravimetric Approach
Live Webcast: Wednesday, May 22, 2013 at 11:00 EST, 15:00 UTC (GMT), 16:00 BST
Register Free at www.pharmtech.com/minimizingOOS

GSK Announces Plans to Share Clinical Trial Data
In its commitment to transparency, GlaxoSmithKline (GSK) has outlined plans to share detailed data from its clinical trials. GSK is to establish a new online system that will enable researchers to request access to anonymised patient level data.
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Cleaning Validation: Science, Risk, and Novel Approaches to Testing
Live Webcast: Tuesday, June 4, 2013 at 11:00 am EDT
Register Free at www.pharmtech.com/testing

European Medicines Agency Changes Procedures for Orphan Drug Fees
EMA streamlines orphan drug application procedure.
Click Here to Read More

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Avoid the 483–Unconventional Approaches to Elevate Your Quality Program
Live Webcast: Thursday, May 23, 2013 at 8:00am PDT/ 11:00am EDT
Register Free at www.spectroscopyonline.com/ramananalysis

USP Workshop Addresses Moisture Permeation into Packages
The workshop will cover a proposed new method for measuring moisture vapor transmission rate.
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Risk Mitigation for Alcohol-Dose Dumping in Controlled Release Forms
Live Webcast: Thursday, May 23, 2013 at 10:00 am EST
Register Free at www.pharmtech.com/alcohol

Amgen Forms New Joint Venture to Commercialize Vectibix in China
Amgen and Zhejiang Beta Pharma have signed an agreement to form a joint venture to commercialize Amgen's Vectibix (panitumumab) in the Chinese market. The aim is to quickly and efficiently deliver Vectibix to patients in China. Vectibix is a fully human anti-epidermal growth factor receptor antibody approved by FDA for the treatment of metastatic colorectal cancer.
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Takeda to Acquire Inviragen for up to $250 Million
Takeda and US vaccines maker Inviragen jointly announced that they have entered into a definitive agreement for Takeda to acquire Inviragen for an upfront payment of $35 million and future payments of up to $215 million upon achievement of key commercial milestones, linked to the progress of clinical development.
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Interphex

SCHOTT Doubles Production Capacity for Polymer Syringes
New line in Swiss facility produces ready-to-fill syringes.
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CEM Wins Peptide Patent Dispute with Biotage
CEM Corp. announced that its European Patent covering microwave assisted solid phase peptide synthesis has been upheld.
Read More


Survey
What has been the most significant benefit of applying quality-by-design (QbD) principles?
 
Better process understanding: 67%
 
 
Increased efficiency or reduced waste 9%
     
 
Shorter process times 5%
     
 
Reduced expenses 4%
     
 
Improved ease of making changes 15%
     

This week we would like to know...

How does your company apply quality-by-design (QbD) principles to manufacturing processes?

Click here to vote

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