Newsletter | March 26, 2012

03.26.2012 -- Clarifying The Status Of Extractables And Leachables

Bioresearch Online Newsletter
Sponsor
Sartorius

In This Issue:

Sartobind® STIC membranes are a new group of Salt Tolerant Interaction Chromatography membrane adsorbers. They bind negatively charged impurities such as viruses, DNA, and HCP at much higher salt concentrations than Q matrices. Sartobind® STIC membranes eliminate the need for feedstream dilution before flowthrough polishing of therapeutic proteins and mabs. The single-use product reduces validation cost, consumption of buffers, footprint, and speeds up time to market. www.sartorius-stedim.com/sartobind

Featured Articles

Clarifying The Status Of Extractables And Leachables
By Weibing Ding and Jerold Martin, Pall Life Sciences
There are many reasons why pharmaceutical manufacturers may either embrace the concept of single-use manufacturing or reject it. One concern that is often raised regardless of application is the issue of extractables and leachables.


LIMS Streamlines Translational Science
By Trish Meek, Director of Life Science Strategy, Informatics at Thermo Fisher Scientific
In translation science, organizations are utilizing laboratory information management systems (LIMS) to facilitate collaboration and manage experimental results of clinical outcomes.

Now in its 14th year, TIDES® continues to build upon its reputation as the place to meet all the important players in the oligonucleotide and peptide therapeutics industries, from discovery all the way through manufacturing. Attendees will have access to all four conference tracks:
• Oligonucleotide and Peptide Manufacturing Technology and Product Development
• Oligonucleotide Therapeutics Discovery
• Nucleic Acids Technologies for Molecular Diagnostics
• Peptide Discovery and Development

Spotlight On Purification

SteriLUX® Filters Brochure
The hydrophilic SteriLUX polyvinylidene fluoride (PVDF) membrane filter is available in discs, capsules, high-capacity UltraCap® and UltraCap® H.D. capsules, and cartridges with 0.1 µm, 0.2 µm, 0.4 µm, and 0.6 µm absolute ratings.


Product Sheet: HFC39 Series Couplings — Medical-Grade Polysulfone, 1/4", 3/8", And 1/2" ID
HFC39 couplings feature automatic shutoff valves and offer a cost-effective replacement for expensive, heavy, stainless steel connectors or fittings. HFC medical-grade polysulfone meets the most stringent requirements, such as USP Class VI, MEM elution, agarose overlay, hemolysis in vitro, and USP physicochemical tests.


MODcol® MultiPacker® And Spring® Column Packing Guide
Because it employs a pneumatic packing mechanism, the MultiPacker instrument for 25-mm and 50-mm spring columns uses no electrical power, making it safe for work with many types of solvents and a good column for hazardous environments.


Automated, Single-Use Purification Platforms In Biopharmaceutical Production
The use of disposable bioreactors and single-use purification platforms for normal flow filtration (NFF), tangetial flow filtration(TFF) and preparative chromatography have received significant attention in years. Up until very recently, the use of single-use purification platforms was limited almost exclusively to manually operated systems.

Industry News

Protein Researchers Unravel The Molecular Dance Of DNA Repair
NIH Awards Avaxia Biologics $1.5M Phase II SBIR Grant
Thermo Fisher Scientific Introduces HyCell CHO Cell-Culture Medium
Argen-X Launches NHance™ Technology To Generate Better Human Antibody Therapies
Hamilton Neuros Syringe Maximizes Precision And Minimizes Injection Site Damage
GE Healthcare And BAC Collaborate To Launch New Bioprocess Affinity Resin
BioTek Continues To Benefit Vermont Economy Through China Focus
Shimadzu's Nexera MP UHPLC With Multi-Plate Autosampler Provides High-Speed Analysis With Three Times More Sample Capacity For LC/MS
EMD Millipore Launches Mobius CellReady 50 L Single-Use Stirred Tank Bioreactor
Marken Validates Top Position In Global Clinical Sample Shipments
View more headlines

Featured Multimedia

Stax™ Depth Filter Systems Video
With simplicity, intuitive operation, safety, and speed, Stax depth filter systems are ideally suited for the most demanding prefiltration, clarification, and adsorption applications in the biopharmaceutical industry.

Industry Webinar

Bio-G Webinar: Quality By Design — An Industry Perspective
Bio-G Webinar: Quality By Design — An Industry Perspective
March 28, 2012
1:00 PM PST, 4:00 PM EST
3:00 PM GMT, 4:00 PM CET

In this 60-minute webinar and Q & A session two panelists, Jim Lambert from Genentech and Rick Johnston, Ph.D., from Bio-G, will present their perspectives on Quality by Design (QbD), and answer questions about the implementation of QbD in biopharmaceutical manufacturing.

Featured Products And Services

Real-Time Scheduling
Real-Time Scheduling

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BIO-G

El-O-Matic Actuator
El-O-Matic Actuator

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Emerson Process Management

SciPres Pressure Sensors
SciPres Pressure Sensors

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SciLog, Inc.

SFR Shake Flask Reader
SFR Shake Flask Reader

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PreSens Precision Sensing GmbH

Membrane Filters For Sterile Filtration And Clarification
Membrane Filters For Sterile Filtration And Clarification

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GE Healthcare Life Sciences

Depth Filtration Prefilters, Cartridges, Or Disposable Capsules
Depth Filtration Prefilters, Cartridges, Or Disposable Capsules

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ZenPure Corporation

Sartopure PP2 Filter Cartridges
Sartopure PP2 Filter Cartridges

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Sartorius Stedim Biotech

Conventional Dosage Form Development
Conventional Dosage Form Development

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Patheon Inc.

Thermo Scientific Nalgene InVitro Biotainers
Thermo Scientific Nalgene InVitro Biotainers

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Thermo Scientific Nalgene and Nunc

ELx405 Microplate Washer
ELx405 Microplate Washer

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BioTek Instruments, Inc.

Getinge 633LS Steam Sterilizers
Getinge 633LS Steam Sterilizers

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Getinge USA, Inc.

Fermentor, BioFlo 310 Autoclavable Fermentor, 2.5 To 14 L
Fermentor, BioFlo 310 Autoclavable Fermentor, 2.5 To 14 L

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New Brunswick Scientific