Newsletter | March 17, 2014

03.17.14 -- USP Chapter 41 Details, Reducing Raw Materials Risk, And More

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Quality/Regulatory Supply Chain Integrity Downstream Upstream
Sartobind STIC® — Salt Tolerant Interaction Chromatography
Sartobind STIC® membrane adsorbers, from Sartorius Stedim Biotech, bind negatively charged impurities such as DNA, host cell proteins, endotoxins and viruses at much higher salt concentrations than known from conventional Q matrices. Sartobind STIC® membranes eliminate the need for feedstream dilution before flowthrough polishing of recombinant proteins and Mabs. This single-use product reduces validation cost, consumption of buffers, footprint and speeds up time to bring products to market.
Learn more.
» Featured Magazine Article
Best Practices In Biomanufacturing Supplier Relations: Reducing Raw Materials Risks
By Eric Langer, President and Managing Partner, BioPlan Associates, Inc.
Quality management is a matter of increasing importance to the biopharmaceutical manufacturing industry. In recent years, facilities have been gravitating toward quality-related analytical programs, and our data tells us they are also getting tougher on suppliers.
Featured Focus: Quality/Regulatory
The New USP Chapter 41: Are You Compliant?
By Jennifer Camarda, Sales Specialist, Premium Balances and Software, Sartorius Corporation
As of December 1, 2013, significant changes to the USP Chapter 41, a mandatory chapter, became effective and now apply to all materials that must be accurately weighed. USP Chapter 41 has also been renamed, from Weights and Balances to Balances, and it does not reference the minimum sample weight anymore, but rather it defines repeatability and accuracy, which specifies the operating range of a balance. The operating range is limited to the maximum capacity of the balance and begins at the point at which the balance’s repeatability is less than or equal to 0.10 percent. The weighing must also be performed using a balance that is calibrated over its operating range.
ARTICLE: Accelerate Regulatory Submission Documentation Creation, Review, And Approval
APPLICATION NOTE: High-Throughput Process Development And Scale-Up Of An Intermediate Purification Step For Recombinant Insulin
WHITE PAPER: Checklist For Multivariate Analysis Best Practice
BROCHURE: MET ONE HHPC+ Series Handheld Particle Counters
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» Supply Chain Integrity
WHITE PAPER: Supply Chain Information Sharing And Analysis 4th Quarter 2012 Report Of Cargo Theft Activity
By J.J. Coughlin, LoJack Supply Chain Integrity
Understand the actions of cargo criminals and how they react to industry and law enforcement actions related to prevention and enforcement.
WHITE PAPER: Understand The Source Of Product Damage With Data Loggers
CASE STUDY: Supporting Global Medicinal Delivery At The Right Temperature
PRODUCT: Temperature-Sensitive Shipments: RKN t2 Container
» Downstream
ARTICLE: Metabolic Footprint Of Diabetes: A Multiplatform Metabolomics Study In An Epidemiological Setting
By Michael V. Milburn, Karsten Suhre, Christa Meisinger, et al., Metabolon
Metabolomics is the rapidly evolving field of the comprehensive measurement of ideally all endogenous metabolites in a biological fluid. However, no single analytic technique covers the entire spectrum of the human metabolome.
CASE STUDY: How To Maintain The Same Elution When Scaling A Separation Volume To Column Volume
DATASHEET: Large-Format One-Inch Connectors: AseptiQuik X 
By Colder Products Company
BROCHURE: Development Services: Low-Solubility Compounds
BROCHURE: Chemically Defined Feed Medium, Nonanimal Origin: BalanCD CHO Feed 3
BROCHURE: Monitoring Technology For Medical Steam Sterilization
PRODUCT: Automated Liquid Handling Instruments
» Upstream
APPLICATION NOTE: Achieve High-Density Culture Cells With A Low-Cost Expression System
By Richard Mirro, Eppendorf Inc.
This applications report presents a simple protocol for achieving high-density culture of Pichia pastoris (P. pastoris) cells using a New Brunswick benchtop, autoclavable stirred-tank fermentor or bioreactor.
APPLICATION NOTE: Perfusion/Cell Retention: Attaching An ATF System To Different Bioreactors
DATASHEET: Sentino Microbiology Pump
By Pall Life Sciences — BioPharmaceuticals
POSTERS: Validation Of A 3-Dimensional Liver Microtissue Model For Long-Term Hepatotoxicity Studies
VIDEO: A Single-Use Method Of Removing Samples From A Closed System
BROCHURE: Chromatography Vials
PRODUCT: DASbox: Mini Bioreactor System
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Vendor Qualification And Compliance: What Sponsors And CMOs Must Know
Date: Tuesday, March 25, 2014 • Time: 1pm – 2:30pm EST

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