Newsletter | January 16, 2014

01.16.14 -- Mission TransCelerate: Transforming The Drug Development Terrain

Pharmaceutical Online Newsletter
Departments:
Manufacturing QA/QC Inspection
Critical Environments Logistics Packaging
» Guest Column
Mission TransCelerate: Transforming The Drug Development Terrain
By Rob Wright
During the ill-fated 1970 Apollo 13 mission to the moon, it was astronaut Jack Swigert who alerted ground control that something had gone terribly wrong when he uttered the phrase, "Houston, we've had a problem here." Those same words seem very fitting to the current state of affairs regarding the skyrocketing costs of drug discovery. Recent estimates place the expense of successfully bringing just one drug to market at between $350 million and $1.2 billion. However, in the past decade, companies that brought 4 to 13 drugs to market have watched the price tag reach even more stratospheric heights — orbiting at $5 billion and more. "I think the pain point has reached a threshold that's no longer bearable," states Dalvir Gill, Ph.D., CEO of TransCelerate BioPharma.
UPCOMING TRAINING

cGMP Compliance: Top Trends To Know For 2014
Date: Wednesday, January 22, 2014 • Time: 1pm – 2:30pm EST

FDA GMP Inspections: Proven Preparation And Survival Techniques
Date: Thursday, January 30, 2014 • Time: 1pm – 2:30pm EST

Data Integrity And Manufacturing: Detecting And Mitigating Risk
Date: Wednesday, February 12, 2014 • Time: 1pm – 2:30pm EST
Featured Focus: Manufacturing
Considerations When Selecting Capsule Filling Equipment
By John Van Tol, Harro Höfliger Packaging Systems
When it comes to the topic of capsule filling, the first and most immediate issue to consider is the equipment used for this purpose.  Obviously, selection of the most suitable encapsulator is an extremely important consideration. There are several questions you need to ask while working through the selection process.
WHITE PAPER: The Role Of pH And Residue In Pharmaceutical Cleaning
By Malcolm McLaughlin, Alconox
A great deal is known about how pH affects aqueous critical cleaning. Typically, alkaline cleaners are used on oily residues, and acidic cleaners are used on inorganic residues.
WHITE PAPER: What Is Quality By Design?
CASE STUDY: Pneumatic Conveyor Provides Competitive Edge For New Bio-Based Detergent Expansion
DATASHEET: Vertical Steam Sterilizers: FVG
By Fedegari Group
PRODUCT: Bioprocess Monitoring Tools
PRODUCT: Mycoplasma PES Filter: STyLUX SC0.1 μm
» QA/QC
GUEST COLUMN: Going 'Paperless': Save Time And Improve Data Integrity — Cleanroom Environmental Monitoring
By Tony Harrison, U.K. Subject Matter Expert to ISO Technical Committee 209 Working Group
The intensely manual practices of cleanroom classification and routine monitoring are time-consuming and prone to data errors. Particle counter performance and accuracy can vary widely, leading to inaccurate particle counting data.
WHITE PAPER: Monitoring Chemical Processes For Early Fault Detection Using Multivariate Methods
By Dr. Frank Westad, Chief Scientific Officer, CAMO Software
Multivariate statistical process monitoring (MSPM) has been established as a valuable tool for ensuring reliable product quality in the process industry. However, many organizations today are still not fully utilizing its potential to make significant improvements in their production environment.
WHITE PAPER: A 15-Minute Guide To Efficient And Compliant Management Of GMP Controlled Documents
CASE STUDY: Complete Pharma Packaging Accuracy Peace Of Mind
PRODUCT: Pharmaceutical Air Quality Monitoring
» Inspection
WHITE PAPER: Improve Efficiency In Biocontamination Control And Risk Mitigation
By James Drinkwater, Bioquell Inc.
There is a need to improve efficiency in the pharmaceutical industry to meet the new challenges of globalization, competitiveness, and the increasing diversity of products.
DATASHEET: Portable Airborne Particle Counters: SOLAIR 3100/5100
By Lighthouse Worldwide Solutions
PRODUCT: Rapid Nondestructive Headspace Oxygen Monitoring
PRODUCT: Automated Tablet Inspection Machine: ETIM
PRODUCT: Pharmaceutical Tablet And Tooling Microscope Inspection
» Critical Environments
WHITE PAPER: Reducing Laboratory Fume Hood Energy Consumption
By Luke Savage, LEED Green Associate
There is an ever-increasing demand for laboratories to have a reduced impact on the environment, as well as a lower cost to operate. With this continuing push for reduced energy consumption in laboratories, lab planners, architects, engineers, and lab managers are leaving no stone unturned.
APPLICATION NOTE: Effective Cleaning Of Pipettes
PRODUCTS: 3Flex Surface Characterization Analyzer
PRODUCT: Clipster Aseptic Disconnector
PRODUCT: Laboratory Freezers
» Logistics
CASE STUDY: Reliable Environmental Monitoring System Satisfies Clinical Trial Sponsors And Safeguards Life-Enhancing Research
PODCAST: The Importance Of Asset Tracking In The Pharmaceutical Supply Chain
PRODUCT/SERVICE: Remote Monitoring: Prevent Damage In Shipping
PRODUCT/SERVICE: Global Cold Chain Logistics
PRODUCT/SERVICE: On-Site Packaging And Pickup
» Packaging
APPLICATION NOTE: Capsule Dosing Techniques For Dry Powder Inhalers
PRODUCT: Leak Testing Machine For Filled Bottles
PRODUCT: Metal Detector Conveying Systems
PRODUCT: Odor Contamination Systems And Solutions
PRODUCT: X-Ray Inspection Of Jars, Cans, Bottles: Dyxim Series
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