Newsletter | February 5, 2014

02.05.14 -- Why Do Drugs Fail To Reach Market?

Bioresearch Online Newsletter
Supply Chain Integrity Upstream Downstream Quality/Regulatory
» Featured Magazine Article
Why Do Drugs Fail To Reach Market?
By Wayne Koberstein, Executive Editor
The general impression when a drug fails is that it wasn't a good drug. Well, perhaps the chemists and formulators didn't get it wrong; the plain truth of it is this: Innovations don't just happen on the bench, they also happen in clinical trials.
Featured Focus: Supply Chain Integrity
New Techniques For Streamlining The Inbound Supply Chain For The Clinical Lab Industry
WHITE PAPER: What's The Business Case For Real-Time Temperature Monitoring And Analytics?
CASE STUDY: Transporting Critical Bulk Drug Substance From China Under Controlled Room Temperature
VIDEO: A New Breed Of Healthcare Supply Chain Partner
PRODUCT: SC506S: Real-Time Location And Sensor Cargo Tracking
PRODUCT: ISCLabs: Thermal Packaging Design And Testing Services
PRODUCT: Bio-STAR Technology: Clinical Trial Logistics Management
» Upstream
APPLICATION NOTE: Activated Carbon Cartridges Evaluation And Scale-Up For Pharmaceutical Applications
By Thomas O'Brien, Ph.D., 3M Purification
Activated carbon in the pharmaceutical industry has been used for many years to reduce impurities derived from the reactions that create active pharmaceutical ingredients (APIs). The adsorptive properties and the very large surface area of activated carbon make it ideal for filtering impurities from APIs, with decolorization being the most common pharmaceutical application.
APPLICATION NOTE: High-Density Hybridoma Cell Culture In A Packed-Bed Bioreactor
By Ray Rose, Stacey Willard, and Ma Sha
Packed-bed bioreactor cell culture is generally accepted as one of the best methods to simulate the conditions of animal cell growth in vivo, since cells are maintained in a low-shear environment with constant refreshment of nutrients and removal of waste.
Q&A: Closed Systems For Small-Scale Single-Use Applications
Closed single-use systems reduce the risk of two critical forms of contamination: biological contamination and cross-contamination. Biological contamination includes competitive organisms, such as bacteria, fungi, and yeasts, that are inadvertently introduced into cell culture processes. These organisms utilize culture nutrients, produce unwanted proteins, and limit growth or destroy the intended cell culture. Most biological contaminations result in rapid growth and observable culture changes that indicate a culture must be discarded.
DATASHEET: Anti-Ago2, Monoclonal Antibody
By Wako Laboratory Chemicals
POSTERS: Automated Tissue Culture Cell Fixation And Staining In Microplates
BROCHURE: Integrated BioBanking System 
BROCHURE: Development And Commercial Services: Lyophilization
» Downstream
ARTICLE: Overcoming Obstacles In Final Ultrafiltration Steps
By Nick Hutchinson, Market Development Manager
Cross-flow filtration can be used in a range of applications within biopharmaceutical manufacturing processes.
ARTICLE: Multifunctional Additives For Better Stability Of Botanical And Probiotic Formulations
APPLICATION NOTE: Single-Use Container Closure Improves Biopharm Processes Versus Stainless Steel
DATASHEET: Macro-Prep Hydrophobic Interaction Chromatography (HIC) Support 
By Bio-Rad Laboratories, Inc.
CATALOG: Biopharmaceutical Single-Use, Customized Systems
PRODUCT: PerFix EXPOSE Cell Signaling Kit
PRODUCT: CHO Media Development Kit
» Quality/Regulatory
WHITE PAPER: Developments In Laboratory-Scale Lyophilization For Purification Laboratories
By Rob Darrington, Genevac
For many years, lyophilization, or freeze drying, has been used to dry samples in the laboratory. The technique is well researched, and has become the method of choice for many researchers with a few samples to dry. Lyophilization is often preferred because a high level of dryness is achieved with low residual solvent levels, and because of the light, powdery, 'fluffy' finish of the sample, which enables the sample to be easily removed and weighted out.
ARTICLE: How To Choose The Right Connector For Your Biopharm Application
BROCHURE: DASware Migrate Software: Integrate Different Bioreactor Control Units
BROCHURE: End-To-End Proofreading Inspection Solutions
BROCHURE: EZ BioPac Powder Transfer Process
PRODUCT: Newform, Medical-Grade Packaging
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INTERPHEX is the single source for complete biopharmaceutical and pharmaceutical manufacturing solutions to confidently process all dosage forms of life-enhancing drugs. See, touch, and procure the latest technologies and innovations, March 18 to 20, 2014, at the Javits Center in New York City. For more information visit

CRA Oversight: A Risk-Based Approach
Date: Tuesday, February 11, 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
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