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May 03, 2016
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» Industry News
 
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» Featured Articles
Challenges in Comparability Studies of Glycoprotein Biosimilars
Challenges in Comparability Studies of Glycoprotein Biosimilars
As defined by the US Food and Drug Administration (FDA) “a biosimilar product is a biological product that is approved based on showing that it is highly similar to an FDA-approved biological ... read more »
Points to Consider in Filing Data for Shipment of Temperature Controlled Drug Substances/Products
Points to Consider in Filing Data for Shipment of Temperature Controlled Drug Substances/Products
Twenty years ago, the risk to drug substance/product quality due to temperature excursions during shipping was not generally appreciated. A series of studies led to several papers in USP PF which ... read more »
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» Featured Video
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  Webinar: Using ultrasensitive immunoassays to search for mutant HTT protein in Huntington’s disease patient CSF
Webinar: Using ultrasensitive immunoassays to search for mutant HTT protein in Huntington’s disease patient CSF
Reducing the amount of mutant HTT protein is a key therapeutic strategy for Huntington's disease. In this webinar, learn about a new sensitive and selective assay that measures polyglutamine-expanded ... read more »
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  Interview with MPI Research at AAPS 2015
Interview with MPI Research at AAPS 2015
In this video, Mike Auerbach speaks with Lisa Yoder and Katie Jeschke from MPI Research about the CRO services MPI provides and how they are setting themselves apart in the industry. MPI Research ... read more »

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» Featured Whitepaper
Feasibility of a Rapid Microbiological Method for Filterable Raw Materials
Feasibility of a Rapid Microbiological Method for Filterable Raw Materials
The analysis of pharmaceutical products for microbial contamination is a critical component of pharmaceutical manufacturing. All raw materials and ... read more »
Biocontamination control in pharmaceutical production
Biocontamination control in pharmaceutical production
Biocontamination refers to biological contamination of products by bacteria and/or fungi, as well as the toxic by-products of these microorganisms, ... read more »
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» Events
 
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