Newsletter | January 8, 2014

01.08.14 -- Small Enterprises Make Outsized Contributions With Novel Drugs

Bioresearch Online Newsletter
Departments:
Supply Chain Integrity Upstream Downstream Quality/Regulatory
» Featured Magazine Article
The Microinnovators: Small Enterprises Make Outsized Contributions With Novel Drugs
By Wayne Koberstein, Executive Editor
So simple in concept — interview three CEOs of companies developing novel drugs — so challenging in execution. Who would have guessed there is such a strong correlation between novel-drug development and small-company volatility? Since my investigation began, one company replaced its CEO and changed its name, another's stock rose and fell repeatedly on news of a competing product, and a third one joined late in place of another that dropped out. All of those events are among the most common disruptions in business and communications for the microenterprises focused on unique paths of medical innovation. Thus, I stumbled upon a key insight into the lives of this industry's microinnovators: It's never easy.
UPCOMING TRAINING

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: Supply Chain Integrity
DHL: Interconnectedness In The Cold Chain
By Vivian Berni, Strategic Marketing and Communications Manager, LifeConEx 
When faced with environmental uncertainties, leveraging a network of trusted partners becomes a critical link in the transportation process for temperature-sensitive medicinal products.
WHITE PAPER: A Challenge For Supply Chain Performance Is The Complexity
CASE STUDY: How DSC Helped DowBrands Achieve Cost Efficiency And Exceed All Other Goals
DATASHEET: Certis Qualified Shipping Series 
By ThermoSafe, Sonoco Protective Solutions
BROCHURE: Temperature Integrity For Clinical Trial And Drug Development Logistics
BROCHURE: BarProof Barcode Inspection
» Upstream
APPLICATION NOTE: Reduce Cost, Increase Quality, And Shorten Cycle Time In Upstream Manufacturing-Scale Cell Culture
APPLICATION NOTE: Successfully Cultivate Hybridoma Cells In A Fibra-Cel Packed-Bed Basket
APPLICATION NOTE: Characterization Of Protein Structural Stability In Response To Elevated Temperature
APPLICATION NOTE: Laser-Induced Breakdown Spectroscopy (LIBS)
DATASHEET: Helium Integrity Testing (HIT) 
By ATMI LifeSciences
BROCHURE: Anti GFP, Monoclonal Antibodies
BROCHURE: Filter Systems For Pharmaceutical Separations
» Downstream
ARTICLE: Fully Controlled Cultivation Of Human Pluripotent Stem Cells Using A Parallel Bioreactor
By Ruth Olmer, Ph.D., Sebastian Selzer, and Robert Zweigerdt, Ph.D.
Human pluripotent stem cells (hPSCs) and their derivatives have gained increased importance for industrial applications in recent years.
DATASHEET: DuraPure Bioprocess Bag Systems
By Parker domnick hunter Process Filtration
VIDEO: Microplate Washer For ELISAs And Cells
VIDEO: DHX Disposable Heat Exchanger Animation
BROCHURE: HyPerforma Single-Use Mixer DS 300
PRODUCT: Ion Exchange Media
PRODUCT: PerFix-nc Assay Kit: Flow Cytometric Analysis
» Quality/Regulatory
ARTICLE: What Exactly Is The Cloud?
By Victor Gill, MasterControl Inc., Senior Product Manager of Cloud Solutions
What exactly is Cloud? Or is it, The Cloud? Is it just me, or do no two people describe it the same way? As the product manager over the Cloud initiative at MasterControl I hear these kinds of questions all of the time. With all of the advertising, mixed messaging, technical jargon, and promises of grandeur, it's easy to see why so many consumers are confused. At its heart, the term The Cloud has been a powerful marketing turn of phrase that has consolidated a large mix of technologies.
BROCHURE: New Paradigm For Process Optimization And Control
BROCHURE: EMC Documentum Quality Manufacturing Solution For Life Sciences
CATALOG: Electrochemical And Optical Sensors
PRODUCT: EZ BioPac: Powder Transfer Process
PRODUCT: Cell Counter For Cell Viability Analysis
PRODUCT: Contract Manufacturing And Packaging Services
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