Newsletter | January 15, 2014

01.15.14 -- New Diabetes Drug Approved By The FDA

Bioresearch Online Newsletter
Downstream Supply Chain Integrity Quality/Regulatory Upstream
» Featured Magazine Article
Will Protagonist Be The Hero In Making Stable Oral Peptides To Replace Injectables?
By Wayne Koberstein, Executive Editor
Protagonist Therapeutics has created a technology for making stable oral peptides capable of replacing injectable-only drugs, and is developing entirely new oral-peptide therapeutics for GI patients. Its initial development areas are irritable bowel diseases (IBD) and irritable bowel syndrome (IBS). Two compounds, one an injectable peptide to block IL-6, and another an oral peptide to block integrins, will enter clinical trials in 2015.

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
Automating Methods To Improve Assay Performance Suitable For High-Throughput Screening (HTS)
By Peter J. Brescia, Applications Scientist, BioTek Instruments, Inc.
Here we demonstrate the use of a fluorescent polarization assay using SET7/9, a SET domain containing mono-methyltransferase, as a model system suitable for HTS applications in a 384-well microplate format using automated methods and a HTS microplate reader.
POSTERS: A Single, Chemically Defined Culture Medium Supporting A Wide Range Of Development Activities For The Production Of Biologics
By Mark C. Arjona, Catherine Nguyen, Jenny Y. Bang, Tom Fletcher, and Jessie H.T. Ni
In the production of biologics, various development activities require different medium requirements, calling for multiple media. 
POSTER: Progress On A Fully Disposable Downstream Platform
BROCHURE: inSITE Inflation And Integrity Test System
PRODUCT: Optimize Filtration Processing, Maximize Filter Life: SciFlex NFF
PRODUCT: Helium Integrity Testing (HIT)
PRODUCT/SERVICE: Endotoxin Removal Cartridges And Capsules
» Supply Chain Integrity
WHITE PAPER: What's The Impact Of Big Data In The Cold Chain?
VIDEO: GxP Compliance For Clinical Supply
VIDEO: When Shipping Pharma Products, It's Either Very Good Or It's A Disaster
DATASHEET: Envoy Insulated Shippers
By ThermoSafe, Sonoco Protective Solutions
BROCHURE: Maintaining Biological Shipment Integrity: Global Cold Chain Logistics
PRODUCT: GSM Bolt: Cellular-Enabled Bolt Seal For Asset And Cargo Security
» Quality/Regulatory
ARTICLE: Supplier Audits Or Bust: Six Keys To Pharma Audit Success
By KR Karu, Pharmaceutical Industry Solution Director, Sparta Systems
Supply chain integrity is necessary to a pharmaceutical company’s success. When dealing with a multitude of suppliers spanning several geographies, manufacturing issues can arise if proper protocols are not in place. Specific challenges include product purity, regulatory compliance, safety, cost containment, and quality assurance.
ARTICLE: Tapping Into Metabolites To Overcome R&D Challenges And Develop Novel Biomarkers: Part 1
CASE STUDY: A Faster 'Time-To-Market' With Automated Proofreading Solutions
DATASHEET: VHP M100 Biodecontamination System
By STERIS Corporation
BROCHURE: Dri-Pure Sample Integrity Protection System
VIDEO: Greater Flexibility With Genderless Connectors For Small-Flow Sterile Fluid Transfer
PRODUCT: Multisizer 3 Cell Counter: Ultra High Resolution And Multiple Channel Analysis
» Upstream
APPLICATION NOTE: Hypoxic Cell Culture Using Incubator With Precision Low O2 Control
By Stacey Willard, Linette Philip, and Ma Sha
Oxygen is a critical regulator of cellular homeostasis, and as such, oxygen deprivation is lethal to normal cells. In contrast to normal tissues, solid tumors often have regions of significantly reduced oxygenation due to an inconsistent and disorganized blood supply at the center of the tumor.
DATASHEET: Miniature Spectrometer: Light Analysis, Chemical Research, And Raman Spectroscopy
By Avantes BV
VIDEO: Analyze Microliter Samples In Seconds: NanoDrop Lite
BROCHURE: PerFix-nc Assay Kit: Flow Cytometric Analysis Brochure
PRODUCT: ForteBio Dip And Read Biosensor
PRODUCT: Sartocheck 4 Plus Bag Integrity Tester
PRODUCT: Macro-Prep Methyl HIC Media
» Most Recent News
New Diabetes Drug Approved By The FDA
NIH Consolidates Biorepositories Into One Program
FDA To Approve Leukemia Drug For The Second Time
J&J Petitions FDA To Regulate Naming Of Biosimilars
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