Newsletter | January 29, 2014

01.29.14 -- Emerging Markets And Your Global Regulatory Strategy

Bioresearch Online Newsletter
Departments:
Supply Chain Integrity Quality/Regulatory Upstream Downstream
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The routine application of stem cells and their derivatives in regenerative medicine and drug discovery will require the consistent supply of quality cells. Stirred-tank bioreactors represent suitable systems to establish scalable bioprocesses enabling the required cell production.
Learn more on the successful cultivation of human pluripotent stem cells in suspension culture using Eppendorf BioBLU 0.3 Single-use Vessels. Download application note.
» Featured Magazine Article
Emerging Markets And Your Global Regulatory Strategy
By Suzanne Elvidge, Contributing Editor
For pharmaceutical companies, aligning the regulatory strategy across many countries saves time and money for drug developers, resulting in earlier access by patients.
Featured Focus: Supply Chain Integrity
Laboratory Instrument Tolerances: Manufacturer vs. Process
By Michael Boetzkes, Quality Manager, Vaisala Canada Inc. Life Science Division
Using the instrument maker's tolerance, there is often a higher risk of an "Out of Tolerance" appearing on a calibration certificate; this costs money. Consider the following scenario: You have just received back from calibration the set of temperature sensors used to monitor the warehouse. Most of the instruments have been shown to be within manufacturer-published tolerances. A few of the instruments, though, are listed as out of tolerance. Now the fun starts!
ARTICLE: Risk Management: Controlling Supply Chain And Process Risk In Biomanufacturing
WHITE PAPER: Qualifying A Packaging System Under Most Challenging Conditions
By Frank Butch, Engineering Manager
A case study to detail the nuances, benefits, and ramifications of qualifying a packaging system to the most challenging conditions.
WHITE PAPER: Why A Closed-Loop Supply Chain System?
By Dr. Rüdiger Lomb, Global Director, Quality and Technical Compliance, World Courier
This article covers improving compliance and efficiency in the pharmaceutical supply chain with reduced cost and risk. How does the sponsor ensure that product transfer conforms to the same established written procedures demanded at the investigator level throughout the full length of the supply chain, or more specifically, while in the hands of nonpharmaceutical, noninvestigator personnel?
WHITE PAPER: Supply Chain Management Is The Key To Growth For Pharmaceutical And Medical Device Manufacturers
By Scott Szwast, Healthcare Segment Marketing Director, UPS
It has been said that "demographics are destiny," and this is certainly true of the global growth of the middle class. Newly empowered consumers around the world are creating dynamic and expanding new markets for products that promise to sustain and improve the quality of their lives. International trade has become particularly important for pharmaceutical and medical device manufacturers, because 57 percent of demand is now found outside of North America. Foreign markets are also manifesting the fastest growth. Yet less than one percent of U.S. healthcare companies export. What factors hinder pharmaceutical and medical device organizations from participating in the large and growing global marketplace? Many companies cite two primary concerns as the impediment to taking their businesses beyond a solely domestic focus.
WHITE PAPER: The Reputational Risk Of Poor Cold Chain Visibility
» Quality/Regulatory
WHITE PAPER: Multivariate Data Analysis For Dummies
By Brad Swarbrick, CAMO Software
As a global leader in the pharmaceutical industry, Wyeth utilizes Global Vision's solutions to help reduce the risk of errors from occurring at key stages throughout the artwork workflow process. As a customer for more than a decade, Wyeth has adopted and benefited from this type of technology early on.
WHITE PAPER: How To Solve Printed Packaging Workflow Issues Without Changing Your Whole Process
DATASHEET: Bambanker Serum-Free Cell Culture Freezing Medium
By Wako Laboratory Chemicals
BROCHURE: Simplify Clinical Trials Documentation And Reduce Compliance Risk
BROCHURE: Cell Counter For Cell Viability Analysis: Vi-CELL XR
PRODUCT: Biodecontamination Of Isolators
PRODUCT: Leak Testing Equipment For IV Bags
» Upstream
WHITE PAPER: Automation Of Cell Staining
By Amy N. Yoder and Li Liu, Beckman Coulter Life Sciences
Automation with the Biomek 4000 platform can improve the throughput and reproducibility of conventional staining of adherent cells. Applicability is demonstrated using mouse embryonic stem cells (mESCs) to detect the expression of developmental antigens in fixed cells following differentiation to cardiomyocytes, which is relevant to stem cell biology research.
WHITE PAPER: A High-Throughput Static Culture Flask Alternative To Shake Flask Culture
By Brandy Nunez, Brian Canna, MBA, and Jessie Ni, PhD
Irvine Scientific specializes in developing and manufacturing cell culture media for bioproduction. To ensure the utility of the medium, CHO cell lines are tested for density, viability, and productivity.
APPLICATION NOTE: Purification Of A Miniature Recombinant Spidroin Protein Expressed In E. Coli
APPLICATION NOTE: Filtration Processes Applied In Therapeutic Monoclonal Antibody Production
DATASHEET: Sentino Filter Dispenser: Membrane Filter Technique
By Pall Life Sciences - BioPharmaceuticals
VIDEO: Fully Control The Aseptic Filling Process With No User Interaction
PRODUCT: Lab And Process Sensors
» Downstream
WHITE PAPER: Improved Purification Of Lead Generation Compounds By Flash Chromatography
By Rakesh Bose, Scott Anderson, Kathy Lawrence, and Melissa Wilcox 
During pharmaceutical development of biologically active compounds, the identification and purification of unknown impurities is a key requirement for the successful registration of a new molecular entity. 
APPLICATION NOTE: Rapid And Efficient Determination Of Kinetic Rate Constants
DATASHEET: Quantum Lab-Scale Chromatography Products
By Natrix Separations
DATASHEET: HyQ Labtainer BioProcess Containers
By Thermo Scientific HyClone
BROCHURE: SFE Filter Cartridges For Small Batch Processing
PRODUCT: Sartobind Ion Exchange Membrane Adsorber Capsules
PRODUCT: Steam-Thru II Connections: Transition From Stainless And Single-Use Systems
» Most Recent News
FDA Approves Covidien's LigaSure Maryland Jaw Device
AMAG's Shares Drop As FDA Rejects Feraheme For Wider Use
Genzyme's MS Drug Aubagio Recommended By NICE
Amgen Phase III GAUSS-2 Trial of Evolocumab Meets Co-Primary Endpoints Of LDL Cholesterol Reduction
Roche's Investigational Schizophrenia Drug Bitopertin Phase III Studies "Disappointing"
SPONSOR
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 www.INTERPHEX.com.
UPCOMING TRAINING

Source Data Review (SDR) vs. Source Data Verification (SDV) — A Site Monitoring Best Practices Update
Date: Friday, January 31, 2014 • Time: 1pm – 2:30pm EST

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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