Newsletter | April 9, 2014

04.09.14 -- J&J's Paul Stoffels Expands The Janssen Legacy; AstraZeneca And MRC Partnership

Bioresearch Online Newsletter
Quality/Regulatory Downstream Upstream Supply Chain Integrity
» Featured Magazine Article
J&J's Paul Stoffels Expands The Janssen Legacy
By Wayne Koberstein, Executive Editor
Speaking with Paul Stoffels is like continuing a long-ago conversation with the late Paul Janssen. A generation younger than the original Janssen company founder, Stoffels now has responsibilities similar to his former boss and mentor, but for a much larger and more complex company now under the Janssen name.
Featured Focus: Quality/Regulatory
The Changing Regulatory Landscape: How Drug Sponsors And CMOs Can Navigate It Together
By Milton Boyer, President, OSO Biopharmaceutical Manufacturing
The changing regulatory environment is shaping a new paradigm between drug sponsors and contract manufacturing organizations (CMOs). One key aspect is demonstrated quite nicely in a case study from February 2012 (read it here), when the FDA issued a warning letter to a contract manufacturing organization.
APPLICATION NOTE: Hygienic Processing: Elimination Of Dead Space Volume
WHITE PAPER: Biodecontamination Of Animal Rooms And Heat-Sensitive Equipment With Vaporized Hydrogen Peroxide
CASE STUDY: EDC And Getting Ready For Migration
BROCHURE: How Efficient Are Your Document Management Processes?
CATALOG: Laboratory Electrodes Technology
PRODUCT: Precision Data Loggers For Regulated Environments
» Downstream
Q&A: The Benefits Of Combination Connections For Single-Use Bioprocessing
By Brent Bushnell, Bioprocess Applications Specialist, Colder Products Company
This short, detailed Q&A provides information about combination connections and explains their use in single-use bioprocessing. It offers a guide on how single-use systems can be designed to integrate the combination connectors and discusses applications that benefit from utilizing them.
APPLICATION NOTE: A New Single-Pass TFF Technology To Simplify Processes And Lower Costs
APPLICATION NOTE: Successfully Grow High-Density Microalgae Culture: Take Advantage Of The Growing Market
BROCHURE: Freeze-Drying Formulation Development
PRODUCT: Sterilizing-Grade Filter Cartridges And Capsules: LifeASSURE SP Series
PRODUCT: Easy-To-Use Preparative System For Laboratory-Scale Protein Purification
» Upstream
WHITE PAPER: A High-Throughput Static Culture Flask Alternative To Shake Flask Culture
By Brandy Nunez; Brian Canna, MBA; and Jessie Ni, Ph.D.
Irvine Scientific specializes in developing and manufacturing cell culture media for bioproduction. To ensure the utility of the medium, CHO cell lines are tested for density, viability, and productivity.
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: Semiautomation Of A Nonradioactive, Antibody-Dependent, Cell-Mediated Cytotoxicity (ADCC) Assay (Part I)
DATASHEET: microRNA Isolation Kit, Human Ago2: Prepare High-Purity Fractions
By Wako Laboratory Chemicals
BROCHURE: Parallel Bioreactor Systems For Microbiology
» Supply Chain Integrity
ARTICLE: New Investments In Asia Enable Envirotainer To Respond To High Market Demand
BROCHURE: Mobile, Wireless Tracking Devices To Monitor Cargo
PRODUCT: Mobile Refrigeration/Freezer Unit
PRODUCT: Cargo Companion Tracking Solution
» Most Recent News
AstraZeneca Enters Drug Discovery Partnership With MRC
Daiichi Sankyo Partners With UCSF To Develop Neurodegenerative Drugs
Eisai Ally H3 Biomedicine To Present SF3B1 Data At AACR 2014
Researchers Identify Achilles Heel Of Malignant Tumor Cells
FDA Approves CardioCell's Phase 2A Trial For CHF Stem Cell Therapy

Source Data Review (SDR) vs. Source Data Verification (SDV) — A Site Monitoring Best Practices Update
Date: Friday, April 11, 2014 • Time: 1pm – 2:30pm EST

Root Cause Analysis for GCP — A Risk Action Plan Guide
Date: Tuesday, April 15, 2014 • Time: 1pm – 2:30pm EST
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