Newsletter | February 20, 2012

02.20.12 -- FDA Gives New Guidance On Biosimilar Development

Bioresearch Online Newsletter
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Pall Life Sciences - BioPharmaceuticals

In This Issue:

SPONSOR

Toolbox Simplifies Process Scale Up

Toolbox Simplifies Process Scale Up

Pall's UpScaleSM Program Toolbox is an attractive, easy-to-use, and easy-to-restock sample cabinet that allows users to test a comprehensive range of scalable products for direct flow filtration, tangential flow filtration, and chromatography. It can be used to find the best solution to meet application requirements in terms of quality, time, and cost reduction. Learn more.

Executive Q&A

Applications And Benefits Of Polyethylene Membrane Filters
A Q&A With Kenneth J Renfrew, MS., MBA, VP, ZenPure America's Inc.
For sterile air and gas filtration, hydrophobic PVDF membrane was the pharmaceutical engineers' historical filter membrane of choice. Then PTFE became a reliable option offering higher flow rates and greater voids volume within the matrix of the membrane. PTFE also had higher temperature tolerance, meaning it worked great for hot air filtered in huge volumes into large fermenters used to produce antibiotics like erythromycin.

Featured Article

DNA Removal From Bioprocess Purification Processes
By 3M Purification Inc.
Many new biological drug products produced using recombinant DNA technology, such as monoclonal antibodies, are produced in cell culture. The host cell produces the therapeutic proteins that are often secreted outside the cell into the surrounding culture medium.

Spotlight On Separation And Filtration

Q&A: 7 Things You Need To Know About Biopharmaceutical Powder Charging With Flexibles
Alan George is the product manager for ILC Dover's flexible containment and disposable systems and has been actively supporting the development of flexible containment solutions for a wide range of processing equipment for more than 13 years. In this Q&A, Alan responds to seven questions concerning the use of flexibles to support powder charging in biopharmaceutical operations.


Disposable Capsule Filters
Meissner capsule filters are ready-to-use disposable filter assemblies. They are ideal for use in small batch and critical point-of-use applications, in liquid or gas service. Each capsule filter consists of a pleated filter element integrally sealed into a rugged polypropylene housing.


Ready-To-Use Fluid Management Solutions For Cross Flow Filtration Systems
A selection of fluid management components from GE Healthcare's ReadyToProcess platform of disposable and single-use equipment was used to arrange buffer and sample management solutions for two large-scale filtration setups.


CESI 8000 High-Performance Separation-ESI Module With OptiMS Technology
The CESI 8000 High-Performance Separation-ESI Module is designed for mass spectrometry applications that analyze charged and polar molecules. Thanks to its robust OptiMS technology, the advantages of CE are now delivered to the mass spectrometer without dilution or disturbance.


Actuated Valves
These pneumatic actuators from Aquasyn feature lightweight performance plastic housings, precision stainless internals, and O-rings machined and molded to tight tolerances.

Industry Webinar

Biopharmaceutical Production: Facility Design Strategies For Single-Use Technologies
February 29, 2012

This webinar will discuss the impact of different strategies for facility design using single-use technology, with a focus on:
• Replacement of traditional equipment with the single-use equivalent
• Biopharmaceutical manufacturing in a single room
• Benefits of facility design with respect to cost, risk, and flexibility

Industry News

FDA Gives Guidance On Biosimilar Development In U.S.
The Developing Genome?
Can TB Treatment Be Guided By Patients' Genetics?
Courtagen, Tetracore In Biodefense Deal
INTERPHEX Unveils Conference Programming For May 2012 Event
Sartorius Stedim Biotech Launches UniVessel SU Single-Use Bioreactor For Small-Scale Cell Culture Applications
Why Bad Immunity Genes Survive
Medicago Receives US$3.56M From The U.S. Department Of Defense
Valeant Pharmaceuticals To Acquire Eyetech
Yeast Lytic Enzyme Mixture Offers Superior Activity
View more headlines

Bulletin Board

UPS Survey Unveils Healthcare Supply Chain Trends
UPS Survey Unveils Healthcare Supply Chain Trends
The 2011 UPS "Pain in the (Supply) Chain" survey explores top business and supply chain concerns at pharmaceutical, biotech, and medical device companies worldwide. Findings show changes in healthcare legislation, reform, and intellectual property protection are major concerns as the industry's pace accelerates globally. View report.

Industry Event

2012 AAPS National Biotechnology Conference
May 19 to 24, 2012 | San Diego, CA

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Featured Products And Services

T500: Small- To Mid-Size Bioreactor System
T500: Small- To Mid-Size Bioreactor System

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Finesse Solutions, LLC

SmartAudit Software: Internal/External Audits
SmartAudit Software: Internal/External Audits

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Pilgrim Software Inc.

Adverse Event Reporting, Safety And Compliance Software
Adverse Event Reporting, Safety And Compliance Software

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Sitrof Technologies

Sterilizing-Grade PES Membrane Filters For Media And Process Fluids
Sterilizing-Grade PES Membrane Filters For Media And Process Fluids

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ZenPure Corporation

Stax™ Disposable Depth Filter Systems
Stax™ Disposable Depth Filter Systems

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Pall Life Sciences - BioPharmaceuticals

ÄKTA™Ready Liquid Chromatography System
ÄKTA™Ready Liquid Chromatography System

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GE Healthcare Life Sciences

Clinical Trial Support
Clinical Trial Support

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Marken

Mycoplasma Testing Services Listing
Mycoplasma Testing Services Listing

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Bionique Testing Laboratories, Inc.

Platelet Sampling Devices
Platelet Sampling Devices

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Charter Medical, Ltd.

Sartocon® ECO
Sartocon® ECO

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Sartorius Stedim Biotech

ATF System: Perfusion And Cell Retention
ATF System: Perfusion And Cell Retention

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Refine Technology, LLC

Bio-Gel Hydroxyapatite HT And HTP Media
Bio-Gel Hydroxyapatite HT And HTP Media

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Bio-Rad Laboratories, Inc.