Newsletter | January 22, 2014

01.21.14 -- Proteon Therapeutics Develops A Drug To Prevent Dialysis Access Failure

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» Featured Magazine Article
Proteon Therapeutics Develops A Drug To Prevent Dialysis Access Failure
By Wayne Koberstein, Executive Editor
Proteon Therapeutics has the singular purpose of treating the bane of nearly all kidney dialysis patients — stenosis and failure of the surgically placed vascular access for hemodialysis. Access failure leads to thrombosis and surgical interventions to restore blood flow such as thrombectomy, angioplasty, and often creation of a new access. Proteon's PRT-201, a "locally-acting recombinant human elastase," is applied to the external surface of the artery and vein during the surgical procedure. Having completed a Phase 2 trial and with FDA orphan and fast-track status, the drug is intended to reduce tissue growth inside vessels that causes poor blood flow, thrombosis, and vascular access failure.

CRO Oversight: Risk Assessment And Action Planning
Date: Tuesday, January 28, 2014 • Time: 1pm – 2:30pm EST

Data Integrity And Manufacturing: Detecting And Mitigating Risk
Date: Wednesday, February 12, 2014 • Time: 1pm – 2:30pm EST

Quality By Design (QbD) In Clinical Trials: Build Bullet-Proof Protocols
Date: Tuesday, February 18, 2014 • Time: 1pm – 2:30pm EST
Featured Focus: Downstream
Automated Bioluminescent ADCC Reporter Bioassay Using Bioengineered Jurkat Cells
By Tracy Worzella, Promega Corporation; and Brad Larson, Applications Department, BioTek Instruments, Inc.
Pharmaceutical companies are increasingly exploring new biologic and biosimilar products, and thus increasing monoclonal antibody (mAb) immunotherapeutic research.
APPLICATION NOTE: Improving Aggregate Removal From Monoclonal Antibody Feed Using High-Resolution Cation Exchange Chromatography
DATASHEET: Temperature And Agitation Control For All Cultivation Processes
By DASGIP Information and Process Technology GmbH an Eppendorf Company
VIDEO: One-Inch Sterile Connectors For High-Flow Applications
BROCHURE: Advanced Powder Transfer For Media And Buffer Preparation And Solids Additions
PRODUCT: Sartobind Ion Exchange Membrane Adsorber Capsules
» Upstream
APPLICATION NOTE: Recombinant GPCR Production In A Stirred-Tank Bioreactor
By K. Christopher Min, Yan Jin, and Vikram Gossain
We have been studying rhodopsin with an interest in determining the conformational change that leads to signal transduction in this class of receptors.
APPLICATION NOTE: A Platform Approach For The Purification Of Domain Antibodies (Dabs)
DATASHEET: HyQ BioProcess Containers For Sterile Fluid Handling 
By Thermo Scientific HyClone
DATASHEET: PerFix EXPOSE Cell Signaling Kit 
By Beckman Coulter, Inc.
POSTER: Viral Vector Production In A Single-Use, Fixed-Bed Bioreactor, From Bench Scale To Industrial Scale
By A. Lennaertz, S. Knowles, J.C. Drugmand, and J. Castillo, ATMI LifeSciences
Wild-type or recombinant viruses used as vaccines and human gene therapy vectors are an important developmental tool in modern medicine. Some have demonstrated high potential such as lentivirus, paramyxovirus, and adeno-associated-virus (AAV).
PRODUCT: Protein Quantitation And Kinetic Characterization Detecion: Octet HTX System
PRODUCT: Automated Tangential Flow Filtration System: SciFlex TFF
» Quality/Regulatory
APPLICATION NOTE: Improve Tablet Uniformity And Hardness While Reducing Friability And Variation
ARTICLE: Simplifying Cancer Complexity And Improving Clinical Success With Metabolomics: Part 2
By Dr. Kirk Beebe
Cancer is an extraordinarily complex disease involving a heterogeneous mix of genetically mercurial cancer cells, stroma, and microenvironment across at least 200 different cancer types. Even with a specific cancer type, heterogeneity within patients impairs clinical development. Thus, the clinical challenges are substantial — to produce a meaningful regression or survival benefit based on targeting an important aspect or aspects of this complex biology.
BROCHURE: Sartocheck 4 Plus Bag Tester 
BROCHURE: EMC Documentum Electronic Trial Master File Solution
PRODUCT: Analyze 36 Bottles: PAT700 AutoSampler
PRODUCT: EZ-2 Personal Evaporator
PRODUCT: Single-Use Heat Transfer
» Supply Chain Integrity
WHITE PAPER: One Of The Biggest Challenges And Most Effective Tools To Managing Cold Chain Logistics
CASE STUDY: Destiny Digital Pens Help Keep Medical Supplies Moving
CASE STUDY: When It Comes To Shipping Perishables, It's The Little Things That Make A Big Difference
BROCHURE: QuickSTAT Clinical Trials 
PRODUCT: Greenbox Reusable Thermal Packaging
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