Newsletter | July 2, 2014

07.02.14 -- EMD Serono And Mersana Enter ADC Collaboration; FDA's First Draft Guidance Under DSCSA

Bioresearch Online Newsletter

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November 10 and 11, 2014 | Hyatt Regency, San Francisco, CA

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Featured Focus

FDA's First Draft Guidance Under DSCSA: What It Tells Us And What It Doesn't
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
On June 10, the long-awaited first draft guidance under the DSCSA was released by the FDA. For those holding high expectations that the guidance would offer specific direction on how to handle suspect/illegitimate products internally, you may come away feeling a little shortchanged. However, in the past, the FDA has come under scrutiny for using guidance to replace rule making, since this requires legislative involvement, so the lack of detail in the draft may be an effort to make room for flexibility that industry felt they weren't getting before. Whatever the intent, the draft guidance does provide some learning opportunities, and also a very subtle call to action. I recently spoke with David Colombo and Dawn Wang of KPMG Life Sciences Advisory to find out what can be learned from this draft and where we go from here.

Featured Content

Application Note: Introduction To Escherichia Coli In A Stirred-Tank Bioreactor
By Richard Mirro, Eppendorf Inc.
This applications report presents a simple protocol for achieving high-density culture of Escherichia coli (E. coli) cells using a New Brunswick benchtop, autoclavable stirred-tank bioreactor.


Application Note: Removal Of Endotoxin From Monoclonal Antibodies
By Sartorius Stedim Biotech
It is desirable to minimize endotoxins in purified protein preparations prior to their use in cell-based assays. Vivapure centrifugal anion exchange membrane devices can remove endotoxin from research-grade monoclonal antibody solutions simply and with high-protein recovery.


White Paper: Securing The Brand Packaging Workflow
By Global Vision Inc.
Packaging represents the brand for each product. Shiny surfaces, vibrant colors, and immersive designs all serve a purpose to capture the attention of consumers on crowded retail shelves.


Poster: How To Choose A Solid Carrier For Liquid Formulations
By Raghunadha Gupta, Chitra Sundararajan, Thomas Pauly, Fred Monsuur
Get the benefits of solid dosage forms in liquid dose formulations, by converting liquid-based formulations into a solid powder by using a solid carrier to adsorb the liquids. Choosing a solid carrier is a critical factor for a successful conversion, and this study provides details on the most ideal solid carrier.

Most Recent News

EMD Serono And Mersana Enter ADC Collaboration
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OIST Researchers Create Femtosecond Lasers Drug Delivery System
UT Researchers Find Supercomputing Beneficial For Drug Research
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Upcoming Training

 


Monitoring Informed Consent (IC): Frequently Asked Questions
Date: Thursday, July 24, 2014 • Time: 1:00 pm to 2:30 pm EST

Remote Monitoring of Clinical Source Data: Why Not?
Date: Monday, July 28, 2014 • Time: 1:00 pm to 2:30 pm EST

Featured Downloads

Chemically Defined Protein-Free Feed Media: BalanCD CHO Feed 1
BalanCD CHO Feed 1 is a chemically defined, protein-free feed medium designed to provide cell culture nutrients for fed-batch applications in conjunction with BalanCD CHO Growth A.

Biotinylation Of Protein For Immobilization Onto Streptavidin Biosensors
The interaction between streptavidin and biotin is widely used as a system for the rapid, stable, and irreversible noncovalent binding of biological molecules.

DASbox Miniature Parallel Bioreactor Datasheet
The smart design of the Eppendorf DASbox makes the 4-fold units ideal for parallel processing of 4, 8, 12, or more bioreactors. Together with the Eppendorf DASware software solutions, the DASbox supports process development following the Quality by Design (QbD) approach by providing comprehensive information management, integration of third-party analyzers, and design of experiments (DoE) tools, as well as remote access via PC, notebook, iPhone, and iPad.

Sentino Microbiology Pump Datasheet
The small footprint frees valuable benchtop space and provides flexibility in arranging workspace for optimal efficiency and workflow.
Browse the download library

Featured Multimedia

Fully Control The Aseptic Filling Process With No User Interaction
ASI's filling system, when used in conjunction with good technique and a laminar flow hood, yields an aseptic bag fill. The semiautomatic filling system utilizes a fixture and cap assembly developed and manufactured by ASI, and fully controls the filling interface with no user interaction required with the fill port. What is left after completion is a tamper-evident dispensing port. This results in a cleaner, more efficient, and cost-effective method of filling.

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Sterilizing-Grade Filters: Small Molecule And API Applications
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3M Purification

Automated Liquid Handling Instruments
Automated Liquid Handling Instruments

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Hamilton Company

Containment: Granulator Technology
Containment: Granulator Technology

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ILC Dover

Quantitative And Reproducible Fluid Measurement
Quantitative And Reproducible Fluid Measurement

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Parker domnick hunter Process Filtration

Ready-To-Use Media For Purification Of Biomolecules
Ready-To-Use Media For Purification Of Biomolecules

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Bio-Rad Laboratories, Inc.

cGMP Biologics Manufacturing Services
cGMP Biologics Manufacturing Services

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Therapure Biopharma Inc.

Eliminate Natural Killer Activity In Cells: Anti Asialo GM1
Eliminate Natural Killer Activity In Cells: Anti Asialo GM1

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Wako Laboratory Chemicals