Newsletter | December 16, 2013

12.16.13 -- Specialty Pharma: Focus On Acorda Therapeutics

Bioresearch Online Newsletter
Quality/Regulatory Downstream Supply Chain Integrity Upstream
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» From The Editor
From Obscurity To Innovation Engine: The Evolution Of Specialty Pharma
By Rob Wright
Twenty years ago when I first started in the life sciences industry, specialty products for rare diseases had the feel of being a company's charitable contribution to society. I recall sitting in a new-hire training orientation listening to the instructor inform us how the profits from our cashcow products supported the R&D and distribution of the specialty products designed to help the unfortunate few suffering from rare diseases. How times have changed!
Featured Focus: Quality/Regulatory
Three Trends In Biological Imaging And Their Impact On Microscope Automation And Control
By Jim Pomager
The field of biological imaging is constantly evolving, driven forward by the increasingly complex and technologically sophisticated demands of the research community. As microscopy and other imaging techniques change, so too must the motion control systems that enable them. Photonics Online recently had the opportunity to talk with John Zemek, executive director of Applied Scientific Instrumentation. ASI manufactures submicron micropositioning hardware for laboratory and microscope automation and OEM systems. Zemek discussed the trends in biological imaging that are having the biggest influence on positioning system design, and what factors you should consider when evaluating such technology for your specific application.
WHITE PAPER: Vaccine Potential And Preclinical Development Needs
By Stephene Rose; Senior Study Director at MPI Research
Few medical advances have made as large an impact on world health as vaccines. Globally, vaccines prevent approximately 10.5 million cases of infectious illness each year. 2.5 million child deaths from diphtheria, tetanus, pertussis, and measles are prevented annually through immunization. Despite these facts, infectious diseases are still the second leading cause of death worldwide, and new infectious diseases continue to emerge.
WHITE PAPER: A 15-Minute Guide To Efficient And Compliant Management Of GMP Controlled Documents
BROCHURE: Development Services: Quick To Clinic
BROCHURE: Multisizer 4 Beckman Coulter Cell Counter
BROCHURE: Bio-Simplex Ultra Carboys For Bioproduction
PRODUCT: Dissolved Oxygen Optical Sensors
» Downstream
ARTICLE: Integrity Testing Of Flexible Containers Using Helium Integrity Testing
By Vishwas Pethe, Tony Paganelli, Sergey Terentiev, Alex Terentiev, and Richard Bhella, ATMI LifeSciences
Switching to single-use systems (bags and hardware) can have financial and performance benefits. However, one of the critical challenges for complete acceptance of single-use systems is assurance of bag integrity, which in turn means assurance of product sterility and operator safety.
APPLICATION NOTE: Minimizing Purification Bottlenecks While Achieving Maximum Sample Recovery
By Scott Anderson, Kathy Lawrence, Dennis McCreary, and Melissa Wilcox, Grace
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.
DATASHEET: Foresight Prepacked Plates And Columns
By Bio-Rad Laboratories, Inc.
DATASHEET: ÄKTA Pure Chromatography System For Fast Purification
By GE Healthcare Life Sciences
PRODUCT: Filter Systems For Pharmaceutical Separations
PRODUCT: Pegasus SV4 Virus Removal Filters
PRODUCT: CELLine Bioreactors Advanced Cell Cultivation Devices
» Supply Chain Integrity
ARTICLE: How To Map Environmentally Controlled Chambers: An Eight-Step Guide
By Bruce McDuffee, Marketing Manager, Vaisala Life Science Division
"Please tell me how to map this chamber!" This is a plea we hear at every Vaisala Good Manufacturing Practice seminar. The question deals with environmentally controlled chambers — everything from small refrigerators or freezers to walk-in chambers or even large warehouses — regulated under cGMP guidelines. Attendees who ask the question are usually more interested in how to map a chamber for maximum reliability or effectiveness, as opposed to meeting the U.S. Food and Drug Administration (FDA) regulations.
CASE STUDY: Marken Overcomes A Snow Emergency To Deliver Life-Saving Drug
DATASHEET: Global Market Intelligence Service Subscription
By Excellis Health Solutions
BROCHURE: Cold Chain Management Dialogue: Cold Chain Solution For Air Transportation
PRODUCT/SERVICE: Bio-STAR Technology: Clinical Trial Logistics Management
PRODUCT: Location-Based Hardwired Tracking
» Upstream
APPLICATION NOTE: An In Vitro Microplate Assay That Can Monitor IL-6 Secretions From SKOV-3 Ovarian Carcinoma Cells
By Brad Larson and Peter Banks, BioTek Instruments, Inc.; Nicolas Pierre, CisBio US Inc.; and Stephanie Georgiou, Enzo Life Sciences
Epidermal growth factor receptor (EGFR) is expressed in up to 70 percent of epithelial ovarian cancers (EOCs). High levels of IL-6 have also been found in the ascites of EOC patients. It has been shown that ligand stimulated EGFR activated NFkB dependent transcription and induced secretion of the pro-inflammatory IL-6 cytokine. In this work we will demonstrate a multiplexed assay for inhibitors at the level of EGFR and NFkB to monitor IL-6 secretion and cell viability.
APPLICATION NOTE: A Study Of A Single-Use Bioreactor System For The Production Of Secreted Proteins
ARTICLE: Tapping Into Metabolites To Overcome R&D Challenges And Develop Novel Biomarkers: Part 1
DATASHEET: Aegis5-14 Film Specifications For Bioprocessing Containers
By Thermo Scientific HyClone
BROCHURE: BioBLU 0.3 Small Vessel, Single-Use Bioreactor
PRODUCT: SciLog Automated Bioprocessing Systems
PRODUCT: Scanning Mobility Particle Sizer Spectrometer 3936
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