Newsletter | March 5, 2014

03.05.14 -- Boehringer Kept Data From FDA Suggests Exposed Pradaxa Analysis

Bioresearch Online Newsletter
Departments:
Upstream Supply Chain Integrity Downstream Quality/Regulatory
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» Featured Guest Column
The Pfizer Approach To Clinical Outsourcing: Develop Capabilities And Align Objectives
By Ed Miseta, Chief Editor, Outsourced Pharma and Clinical Leader
Pam Garzone, executive director of biotechnology and clinical development at Pfizer worldwide research and development, is instrumental in implementing her company's outsourcing strategy. As the clinical team lead, she is accountable for the clinical development strategy for programs originating at Rinat, a research unit within Pfizer. Her duties include working with different functional expert groups such as biologists, clinicians, toxicologists, clinical pharmacologists, and statisticians. "I ensure that everyone on the asset team is in the same boat and rowing in the same direction," she says.
Featured Focus: Upstream
Rip It Up And Start Again: Developing A Bioreactor For Vaccines
By Jose Castillo, Director of Cell Culture Technologies at ATMI LifeSciences
While incremental advances can create solutions to technological problems, sometimes the only way to achieve the required result is to rip up the old rulebook and start from scratch. That’s the approach ATMI LifeSciences took in developing a bioreactor for vaccine manufacture.
DATASHEET: Aegis 5-14 Film Specifications For Bioprocessing Containers
By Thermo Scientific HyClone
POSTER: Validation Of A Three-Dimensional Liver Microtissue Model For Long-Term Hepatotoxicity Studies
PODCAST: Real-Time Glucose Level Measurements In Bioreactors
PRODUCT: Macro-Prep t-Butyl HIC Media
PRODUCT: Affinity Media: Ready-To-Use Media For Purification Of Biomolecules
PRODUCT: Chemically Defined, Protein-Free Medium: BalanCD CHO Feed 1
» Supply Chain Integrity
WHITE PAPER: A Model For Pharmaceutical Supply Chain Quality Agreements
By Rafik H. Bishara, Steve Jacobs, and Dan Bell
More than a decade ago, the way business was conducted between pharmaceutical manufacturing companies and their supply chain providers was typically expressed through verbal expectations at the due diligence meeting, at the audit, or at the first project meeting, and that was pretty much done by using written bullet points.
WHITE PAPER: The Invisible Component Of Cold Chain Management
WHITE PAPER: The Urgent Need For Qualified Transportation Providers
WHITE PAPER: New Lifecycle Comparison Analysis Demonstrates Environmental Impact Difference Between Reusable Thermal Shipper And Single-Use Container
CASE STUDY: Pharmaceutical Company Cuts Packaging Costs
VIDEO: Cold Chain Services: Understand And Ensure Compliance
» Downstream
APPLICATION NOTE: Minimizing Purification Bottlenecks While Achieving Maximum Sample Recovery
By Scott Anderson, Kathy Lawrence, Dennis McCreary, and Melissa Wilcox
By using the RevealX™ detection technology of the Reveleris® system, which independently triggers fraction collection from multiple detectors including UV and ELSD, this work will demonstrate that these bottlenecks can be reduced or eliminated without reducing the recovery of compounds of interest.
WHITE PAPER: Are You Into Biosimilars?
CASE STUDY: Gemin X Pharmaceuticals: Finding A Drug's Mechanism Of Action
BROCHURE: Commercial Supply: Prefilled Syringes And Cartridges
PRODUCT: Concentrated Fed-Batch Technology
PRODUCT: Sterilizing-Grade Filters: Small Molecule And API Applications
PRODUCT: Process Chromatography Columns And Hardware
» Quality/Regulatory
WHITE PAPER: Advantages Of Gamma Irradiation For Effective Sterilization Methods
By Betty Howard, Radiation TechTeam Manager, STERIS Isomedix Services
Many sterilization methods are available for pharmaceuticals, healthcare devices, and labware, including steam, sterile-filtration, ethylene oxide, vapor-phase hydrogen peroxide, electron-beam irradiation, and gamma irradiation. Each technique needs to be evaluated before use based on various criteria. Most importantly, one must consider how the technique will affect the final product characteristics and performance.
WHITE PAPER: Compliance Cloud: A Life Sciences Platform
ARTICLE: EMC Documentum Research And Development Solution
BROCHURE: Air Purifying Respirator System: Sentinel Clear XT
BROCHURE: Sterile Manufacturing Commercial Services
VIDEO: The Power Of Knowledge: inSITE Inflation And Integrity Test System
PRODUCT: MET ONE HHPC 2+ Handheld Particle Counter
» Most Recent News
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Exposed Pradaxa Analysis Suggests Boehringer Kept Data From FDA
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Computers Quicken Pace Of Drug Development And Lower Costs
UPCOMING EVENT
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