Newsletter | December 23, 2013

12.23.13 -- Meeting The Antibiotic Pipeline Challenge

 
Bioresearch Online Newsletter
Departments:
Supply Chain Integrity Downstream Upstream Quality/Regulatory
» Featured Magazine Article
Meeting The Antibiotic Pipeline Challenge
By John McManus, The McManus Group
"For a long time now, there have been newspaper stories and covers of magazines that talked about 'The end of antibiotics, question mark?' Well now, I would say you can change the title to 'The end of antibiotics, period.' We're here. We're in the post-antibiotic era. There are patients for whom we have no therapy, and we are literally in a position of having a patient in a bed, sick with an infection that five years ago we could have treated, but now we can't."
Featured Focus: Supply Chain Integrity
Do Chinese Hamster Ovarian (CHO) Cells Specimens Require An Import/Export License?
By Reynaldo Roman for Marken
On December 21, 2012, the U.S. Fish and Wildlife Service (FWS) finally addressed an issue that has been of significant debate among importers of Chinese hamster ovary (CHO) cell specimens and trade experts. FWS informed the trade community that only shipments of actual CHO "cell," "cell cultures," and "cell lines" are regulated by the agency and require an import/export license for trade.
ARTICLE: Setting New Standards In ULD Handling
By Staffan Ingfors, Head of Global Service Network, Envirotainer
With more than 50 unit load device (ULD) handling locations worldwide, Envirotainer operates the world's largest independent network of ULD ground handling and repair services.
WHITE PAPER: Why A Closed-Loop Supply Chain System?
By Dr. Rüdiger Lomb, Global Director, Quality & 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?
CASE STUDY: When Failure Is Not An Option In The Supply Chain
BROCHURE: Remote Sensor Node: Cargo Asset Monitoring
PRODUCT: Next Flight Out: Expedient Shipping Solution
» Downstream
WHITE PAPER: Faster Flash Purification Of Peptides With Higher Loading And Better Resolution
By Bopanna N.K., Chitra Sundararajan, and Melissa J. Wilcox, Grace Discovery Sciences
Peptides and proteins are becoming increasingly popular for their potential use as therapeutic drugs.
WHITE PAPER: Is Your Single-Use System Supplier Disposable?
By John Briggs, ASQ, CQA, Quality Assurance Manager - ASI
During the past six years, single-use systems and devices have emerged as key agents in the biopharmaceutical landscape.
APPLICATION NOTE: High-Throughput Process Development And Scale-Up Of An Intermediate Purification Step For Recombinant Insulin
APPLICATION NOTE: New C-Flex ULTRA Outperforms Any TPE Pump Tubing On The Market Today
BROCHURE: BalanCD CHO Media 
DATASHEET: Cadence Single-Use TFF Modules 
By Pall Life Sciences - BioPharmaceuticals
BROCHURE: Fibra-Cel Disks: Support System For Cell Cultures
PRODUCT: Syringes And Needles: Precise Fluid Measuring Devices
» Upstream
APPLICATION NOTE: Amino Acid Fermentation: Evaluation Of Scale-Down Capabilities
DATASHEET: Amyloid Beta-Protein Immunohistostain Kit
By Wako Laboratory Chemicals
DATASHEET: SciFlex Semiautomated TFF System
By Parker domnick hunter Process Filtration
BROCHURE: Single-Use Depth Filtration: Zeta Plus
BROCHURE: PerFix EXPOSE Cell Signaling Kit 
BROCHURE: Fibra-Cel Disks: Support System For Cell Cultures
POSTER: Scale-Up Of Hepatic Progenitor Stem Cells From Multiple Tray Stack To 2D Bioreactors
» Quality/Regulatory
WHITE PAPER: 21 CFR Part 11 Industry Overview: Ready For An FDA Inspection?
DATASHEET: Engine Exhaust Particle Sizer Spectrometer 3090
By TSI Incorporated
DATASHEET: Large Format One-Inch Connectors: AseptiQuik X
By Colder Products Company
BROCHURE: Tissue Sterilization Processing Services
BROCHURE: Freeze-Drying Formulation Development
BROCHURE: Cell Counter For Cell Viability Analysis: Vi-CELL XR
BROCHURE: EZ BioPac Powder Transfer Process
» Most Recent News
Merck Collaborates With GSK To Evaluate Novel Combination Regimen For Advanced Renal Cell Carcinoma
GSK and Genmab Receive Priority Review From FDA For New Drug To Treat Chronic Lymphocytic Leukaemia
Grace Announces Additional Patent Granted For Flash Chromatography Technology
AdvantaPure Silicone Tubing For Peristaltic Pumps Carries USP Class VI Approval
FDA Endorses, Pushes For Abuse-Resistant Opioid Formulations
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