Newsletter | March 19, 2014

03.19.14 -- Building New Drugs Just Got Easier

Bioresearch Online Newsletter
Quality/Regulatory Downstream Upstream Supply Chain Integrity
Featured Focus: Quality/Regulatory
NIST Traceability: A Calibrated $2 Thermometer Is Still A $2 Thermometer
By Jim Tennerman, North American Life Science Segment Manager, Vaisala Oyj
Everyone in the quality profession has heard the term “NIST traceable.” Having calibration traceability to the National Institute of Standards and Technology (NIST) is desirable for most measurement devices. It is also enshrined as a requirement in some regulatory documents. Unfortunately, NIST traceability does not ensure measurement quality.
WHITE PAPER: A 15-Minute Guide To Clinical Trial Document Management And The eTMF
WHITE PAPER: Multivariate Data Analysis For Biopharmaceutical And Biotechnology
CASE STUDY: Catalent Approves A Proof Within Hours, As Opposed To Days, With Digitial-Page
CASE STUDY: NAPP Dumps Old System To Overhaul Its SOP Management With NextDocs
PRODUCT: Isomedix Tissue Processing Services
» Downstream
ARTICLE: Rapid Process Improvement Achieved By Applying A Rational Approach To Culture Media Optimization
By Tom Fletcher, Scott D. Storms, and Jenny Y. Bang, Irvine Scientific
The challenge of effective cell culture process development often involves how to simultaneously meet two competing needs: the need to maximize improvement of process performance and the need to minimize time spent on process development.
WHITE PAPER: Automated, Real-Time Monitoring Of Stem Cell Confluence In Large-Scale Cultures
WHITE PAPER: Supporting Advances In MAb Process Development And Manufacturing
DATASHEET: DHX Disposable Heat Exchanger 
By ASI Life Sciences
DATASHEET: Parenteral Development And Manufacturing
By Patheon Inc.
VIDEO: The First Automated, Single-Use Manifold Bag Filling System: FlexAct® MF
POSTERS: How To Choose A Solid Carrier For Liquid Formulations
» Upstream
APPLICATION NOTE: A Study Of Single-Use Bioreactor Systems For The Production Of Secreted Proteins
APPLICATION NOTE: Microcarrier Bead Separation And Cell Harvest Using The HyQ Harvestainer
APPLICATION NOTE: Characterization Of Protein Structural Stability In Response To Elevated Temperature
DATASHEET: DASbox Miniature Parallel Bioreactor
By DASGIP Information and Process Technology GmbH an Eppendorf company
DATASHEET: Anti Asialo GM1 (Rabbit)
By Wako Laboratory Chemicals
BROCHURE: Single-Use Depth Filtration: Zeta Plus
POSTER: Automated Fluorescence Imaging Of GPCR Dependent Second-Messenger Systems
» Supply Chain Integrity
ARTICLE: From Premium Logistics To A True Partner In Global Life Sciences Supply Chain Management
By Wesley Wheeler, CEO, Marken
Part one of Marken CEO Wes Wheeler's ten-part blog series about the changing face of life sciences logistics in today's fast-paced pharmaceutical industry.
WHITE PAPER: How To Classify Biological Specimens For Transport
By Michael Gotz, Director of Dangerous Goods Quick Group of Companies
Transportation of biological substances and infectious materials has become increasingly challenging. Understanding the dangerous goods classification requirements is critical to ensure that your shipments are in compliance with the law.
SURVEY: Assessing The Future Of The Cold-Chain Industry
By Vivian Berni, LifeConEx
In order to gain a deeper understanding of this rapidly evolving market, Sonoco ThermoSafe is conducting a comprehensive and forward-looking survey developed by an advisory panel of industry experts from pharmaceutical manufacturers, logistics companies, media partners, independent consultants, and IQPC event managers.
CASE STUDY: DHL: Interconnectedness In The Cold Chain
PRODUCT: Real-Time Location And Sensor Asset Tracking With Satellite Option
» Most Recent News
Building New Drugs Just Got Easier
$9.8M NIAID Grant To Fund HIV Vaccine Research
GSK Reports Positive Mepolizumab Phase III Study Results
Novartis Receives Recommendation For Bexsero Vaccine In Australia
Weekly FDA Enforcement Report For Drugs And Biologics

Vendor Qualification And Compliance: What Sponsors And CMOs Must Know
Date: Tuesday, March 25, 2014 • Time: 1pm – 2:30pm EST

Computer Systems Validation (CSV) — Avoiding The Top Five Regulatory Pitfalls
Date: Wednesday, April 9, 2014 • Time: 1pm – 2:30pm EST
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