Newsletter | April 21, 2014

04.21.14 -- FDA Develops New Potency Assay For Flu Vaccines; J&J Signs Up As First Partner In Drug Discovery Initiative

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» Featured Magazine Article
Biopharma Quality Management Best Practices: An Approach To Quality Initiatives
By Eric Langer, President and Managing Partner, BioPlan Associates, Inc.
Quality management is an increasingly important focus for biopharmaceutical manufacturers looking to avoid production problems and failures. And it’s increasingly becoming a multifaceted, industrywide concern as regulators take a closer look. With this in mind, it’s useful to see how the industry is approaching quality management in terms of the initiatives being pursued.
Featured Focus: Supply Chain Integrity
Quality Trumps Cost: Moving From Preferred Providers To Strategic Partners
By Wes Wheeler, Marken
Part two of Marken CEO Wes Wheeler's ten-part blog series about the changing face of life science logistics in today’s fast-paced pharmaceutical industry.
WHITE PAPER: Security Of Supply For Chromatography Media
DATASHEET: Certified Air Cargo, Temperature-Controlled Container: RKN e1
By Envirotainer
DATASHEET: Mobile Refrigerator/Freezer: AcuTemp 
By CSafe Global
VIDEO: A New Breed Of Healthcare Supply Chain Partner
BROCHURE: Cellular-Enabled Electronic Bolt Seal For Cargo
PODCAST: The Importance Of Asset Tracking In The Pharmaceutical Supply Chain
» Quality/Regulatory
APPLICATION NOTE: Residual Water Content In Freeze-Dried Product: Importance, Location, And Distribution
By Sophie Koenig, Biopharma Technology Limited
Freeze drying is done to enable long-term storage. Water affects many products both chemically and physically, therefore, removing the moisture stabilizes the product so that its immunologic potency, viability, and integrity are not compromised.
APPLICATION NOTE: Cultivation Of Human CAP Cells: Evaluation Of Scale-Down Capabilities
By Claudia M. Hüther-Franken, Helmut Kewes, and Dr. Michael Schomberg
CEVEC has established a master cell bank (MCB) of CAP cells growing in suspension, tested and certified according to ICH guidelines and European Pharmacopeia. Simple and reliable protocols allow for the fast generation of customized producer cell lines for pharmaceutically relevant proteins based on the parental permanent CAP cells under controlled and optimized conditions.
ARTICLE: Addressing Rare And Respiratory Diseases And Improving Clinical Success With Metabolomics: Part 5
WHITE PAPER: A Unified Approach To Clinical Trials
CASE STUDY: Citation Clinical Labeling Systems Automates For Perfection
BROCHURE: HIAC Liquid Particle Counter 
PRODUCT: Easy Detection Of Phosphorylated Substances: Phos-tag
» Downstream
WHITE PAPER: Understanding Bioprocess Variation Ensures Facility Fit During Technology Transfer
By Nick Hutchinson, Market Development Manager, Parker domnick hunter Process Filtration
The scale-up and transfer of manufacturing processes is common during the life cycle of biopharmaceutical molecules.
APPLICATION NOTE: Insect Cell Culture Using A Benchtop Fermentor/Bioreactor With Spin Filter Assembly
DATASHEET: AseptiQuik S Sterile Connector
By Colder Products Company
DATASHEET: MODcol Multipacker System And DAC Spring Columns
By Grace
BROCHURE: ZEUS Fully Automated Pipetting Module 
VIDEO: CHT Ceramic Hydroxyapatite For Commerical Purification
PRODUCT: Single-Use Bioreactors
» Upstream
APPLICATION NOTE: Parallel Integrity Testing Of Small Venting Filters
APPLICATION NOTE: Activated Carbon Cartridges Evaluation And Scale-Up For Pharmaceutical Applications
DATASHEET: Ultipor VF-Grade DV50 Virus Removal Filter Cartridges
By Pall Life Sciences - BioPharmaceuticals
DATASHEET: WeighStation Quantitative And Reproducible Fluid Measurement 
By Parker domnick hunter Process Filtration
WEBINAR: Implementation Of A Single-Use Heat Exchanger
POSTERS: Engineering Characterization And Cell Culture Application Examples For Two-Dimensional, Orbitally Shaken Single-Use Bags
PRODUCT: Cytation3 Cell Imaging Multimode Reader
UPCOMING TRAINING

Building Accountability On Your Clinical Teams
Date: Tuesday, April 29, 2014 • Time: 1pm – 2:30pm EST

Root Cause Analysis For Clinical Research Professionals
Date: Monday, May 5, 2014 • Time: 1pm – 2:30pm EST

Introduction To Biostatistics: Collecting And Summarizing Data
Date: Wednesday, May 14, 2014 • Time: 1pm – 2:30pm EST
» Most Recent News
New Blood-Based Assay May Help Predict Breast Cancer Recurrence
J&J Signs Up As First Partner In TSRI's Drug Discovery Initiative
U-M Researchers Use Silly Putty Ingredient To Study Stem Cells
MGH Findings Suggest Novel Treatment Approach For Brain Tumors
FDA Develops New Potency Assay For Flu Vaccines
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