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03.03.2010 -- Kick-Starting PAT To Achieve Quality By Design In cGMP Bioprocessing

March 3, 2010

Bioresearch Online Newsletter
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In This Issue:

Featured Articles

Kick-Starting PAT To Achieve Quality By Design In cGMP Bioprocessing
By Technikrom
In 2002 the FDA announced a revolution in how they intended to regulate drug manufacturing. Their initiative promoted a continuous, process-centric approach to validation to replace the current product-centric one.


Phenyl Membrane Adsorber For Bioprocessing
By Sartorius Stedim Biotech
Hydrophobic phenyl membrane adsorbers with a macroporous structure have been developed. The chromatographic membranes are rolled up to cylindrical devices and incorporated into capsules with a bed height of 8 mm. The capsules are of the same design and housing materials as Sartobind capsules used in downstream processes for the removal of charged contaminants or for purification of large biomolecules or viruses.

Featured Downloads

Product Sheet: Applikon Biotechnology AFM Users
Download information on how companies are using the Applikon Alcohol Fementation Monitor for ethanol processes.

Datasheet: Zeta Plus EXT SP Series Depth Filters
The new Zeta Plus EXT Series filter extends depth filtration capacity and extends protection of downstream membranes thereby extending filter life and lowering overall filtration costs. Zeta Plus EXT Series is a family of advanced, dual-zone depth filters designed to provide optimal clarification of bioprocess, biological, and pharmaceutical fluids.

PAT Initiatives And TOC Measurements For Higher Product Quality And Profitability
Recent developments in TOC monitoring technology help advance the use of on-line instruments to fulfill the United States FDA's PAT initiative while increasing manufacturing efficiency.

Media Sterilizer: MEDIACLAVE 10
The MEDIACLAVE 10 allows the rapid and gentle sterilization of 1 liter to 10 liter culture medium. Precise control of process parameters during the sterilization process guarantees media of consistent high quality.
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Industry News

Merck KGaA Buys Out Millipore For $7.2B
New Process Yields High-Energy-Density Plant-Based Transportation Fuel
Asterand Announces The Launch Of Good Laboratory Practice (GLP) Molecular Pathology Services
Thermo Fisher Scientific Adds The Winvale Group To Global Partner Alliance
Abbott And Enanta Announce Advancement Of Hepatitis C Collaboration
Quark Announces Dosing Of The First Patient In Phase I Clinical Trial Of Its Ocular Neuroprotective Agent, QPI-1007
Affymetrix Launches GeneAtlas Personal Microarray System For Whole-Genome Gene Expression
Genomic Health Develops New Methods For Whole Genome Expression Analysis Of Standard Pathology Tumor Specimens
Merck Reports Results Of Phase III Study Of Investigational Oral Allergy Immunotherapy Tablet (AIT)
FDA Approves First Generic Tamsulosin To Treat Enlarged Prostate Gland
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Industry Events

INTERPHEX
April 20 to 22 | New York, NY

Training

Featured Courses From The Center For Professional Innovation And Education

Cleanroom Microbiology For The Nonmicrobiologist
March 15 and 16 | Malvern, PA

Sterilization Procedures: Technology, Equipment, And Validation
March 17 and 18 | Malvern, PA

Aseptic Processing In The Manufacture Of Biotech And Pharmaceutical Products
March 22 and 23 | Costa Mesa, CA

Optimization Of Drug-Like Properties In Drug Discovery: Assessment And Structure Modification Strategies
March 24 to 26 | Costa Mesa, CA

Selecting And Managing CROs
March 29 and 30 | Malvern, PA

Drug Master Files (DMFs): Understanding And Meeting Your Regulatory And Processing Responsibilities
March 31 and April 1 | Malvern, PA

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