Friend's home: 09/02/11

Friday, September 2, 2011

Medarticles NEJM paper request

If anyone can send this one in, it would be great:

http://www.nejm.org/doi/full/10.1056/NEJMra0910111

Thanks,

Pranab

--
Pranab Chatterjee, MBBS
Medical College, Kolkata, India

My Website

Scepticemia

Cargo Cult Medicine
Vagus Journalis

@Scepticemia

--
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Your Inside Look & Savings for BioProcess International 2011

Free Presentation Download & 20% Savings for Bioresearch Online Subscribers

THE Meeting Place for the Bioprocessing Industry

"This conference is always a great opportunity to get a very comprehensive overview on new trends in biologics process development, manufacturing aspects and new trends in the biologics business."

- Wolfgang Noe, Ph.D., formerly Vice President, Bioprocess Development, Biogen Idec

Exchanging Real-World Solutions to Improve Speed, Cost and Predictability

October 31 - November 4, 2011 · Long Beach Convention Center · Long Beach, CA

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Free Online Presentations Download

To give you sneak peek at the caliber of the content presented at BioProcess International - we would like to give you FREE access to a few of our 2010 Keynote and Featured Presentations.

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Agenda

» View the Online Agenda & Session Descriptions

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BioProcess International is your one stop industry resource for driving down costs, improving quality, achieving rapid, robust and resilient process development and manufacturing.

This conference is where challenges are explored, solutions are uncovered and opportunities are developed - and it is the largest and most highly respected event solely dedicated to biopharmaceutical manufacturing.

This year the conference features over 50 presentations with new, previously unpublished data - plus many more to choose from, including keynote presentations touch upon topics from biosimilars to the industry's future direction.

Keynote Presentations

Overview of Approval Pathway under Biologics Price Competition and Innovation Act of 2009

Steven Kozlowski, M.D.
Director, Office of Biotechnology Products, OPS, CDER, US FDA

Bioprocess Technology & Innovation: Strategic Imperative for Challenging Times

Timothy S. Charlebois, Ph.D.
Vice President, Technology and Innovation Strategy, Pfizer

EMA Draft Guideline on Biosimilar Monoclonal Antibodies

Esa Heinonen, M.D., Ph.D.
Member of the EMA Working Group on Biosimilars , Head of Section 2, Marketing Authorizations,
Finnish Medicines Agency (Fimea), Finland

The International Chinese Hamster Ovary Genome Project: Where Do We Go from Here?

Michael Betenbaugh, Ph.D.
Professor, Chemical and Biomolecular Engineering, Johns Hopkins University

Ready or not Biosimilars are Coming to US

Jay S. Stout, Ph.D.
Executive Director, Biologics Manufacturing Sciences and Commercialization,
Merck & Co., Inc.

The Impact of Antibody Drug Conjugates on Process Development and Manufacturing

Morris Rosenberg, Ph.D.
Executive Vice President, Process Sciences,
Seattle Genetics

Integrating Two Biologics Manufacturing Networks

Tim Moore
Senior Vice President, Global Head, Pharmaceutical Technical Operations Biologics, Roche

Fitting the Glass Slipper: Process Design, Plant Capacity, and Value Realization

Jeffrey C. Baker, Ph.D.
Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. FDA

Vac to the Future: Vaccines Bioprocessing and Development

John G. Aunins, Ph.D.
Executive Scientific Director, Merck Research Laboratories

Public-Private Partnering for National Security & Public Health Needs

Robin A. Robinson, Ph.D.
ASPR Deputy Assistant Secretary and BARDA Director, US Department of Health and Human Services

With all these opportunities for gaining new knowledge, meeting new people and having important discussions about the future of the industry, you or someone from your team cannot afford to miss the 2011 conference!

In This Issue:	09/02/11
Detecting Raised Stoppers In Sterile Freeze-Dried Vials Basic Principles Of Dry Granulation And Roller Compaction Technology Technological Advances, Compliance For Temperature Monitoring Why Stick Packaging Is Becoming So Popular	7 Things About Biopharmaceutical Powder Charging Pharma Cautiously Adds Social Media To Marketing Plans Valeant Makes $76M Offer For Afexa ADVENTRX: Meeting With FDA On Three Pipeline Products

New Mixing Technology Reports Now Available

Ribbon Blenders Are Ideal For Coating And Mixing Processes

Select A Powder Induction Mixer That Can Serve Multiple Mix Tanks Of Virtually Any Size

Improve Emulsion Stability Through Ultra High-Shear Mixing

High-Speed Mixing: Saw-Tooth Dispersers vs. Rotor/Stator Mixers

Eliminate "Fish Eyes" In Your Mix

Electronic Variable Speed Promotes Processing Flexibility In Ribbon Blenders: From Soft Start To Discharge

Featured Articles
Detecting Raised Stoppers In Sterile Freeze-Dried Vials By Lighthouse Instruments Lyophilization is a complex process that presents many manufacturing challenges, one of which is maintaining and monitoring container closure integrity of the finished package. Container closure integrity plays an important role in maintaining the sterility and stability of lyophilized products and concerns over patient safety, customer complaints, and the cost of investigations and product recalls are resulting in revised regulatory guidance.

Technological Advances, Compliance Needs Driving The Evolution Of Automated Temperature Monitoring By Gayle Wilton Automation is seen today in almost all aspects of the pharmaceutical industry — from research and development, manufacturing, and compounding — to distribution and storage. In all these instances, advances in technology allow organizations to operate quicker, more safely, and more cost-effectively. Temperature monitoring is no exception.

Basic Principles Of Dry Granulation And Roller Compaction Technology By Gerteis Maschinen + Processengineering AG Granulation is a process in which powder particles are made to adhere to each other, resulting in larger, multiparticle entities, called granules. If such a process is performed without adding liquids, this is called dry granulation.

Why Stick Packaging Is Becoming So Popular By Ropack, Inc. Stickpack packaging in single-dose is globally accepted for its accuracy, convenience and cost savings. These slim, sealed, tube-shaped packets — approximately the size of a stick of gum — are a preferred packaging design among European and Japanese consumers for the convenience, flexibility, and portability their active lives demand.

7 Things You Need To Know About Biopharmaceutical Powder Charging With Flexibles By ILC Dover 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 over 13 years.

Featured Dowloads
Fact Sheet: MiniModule® Membrane Contactors MiniModule® Membrane Contactors from Membrana come in three sizes, which allows them to handle different capacities.

Brochure: ENDURANCE® Models 403 And 403VP — Sanitary Flange Conductivity Sensors Model 403 and 403VP sensors are intended primarily for the determination of electrolytic conductivity in water-for-injection (WFI).

White Paper: Maximizing Confidence In Temperature-Controlled Pharmaceutical Shipping Pharmaceutical products are considered one of the fastest growing and most valuable cargo commodity categories handled by air carriers. It is estimated that biotech and pharmaceutical products represent the highest value per air lifted pound of any cargo shipped by the airlines.

Datasheet: Formed Packaging — Specialized Film/Foil Processes Harro Höfliger uses innovative technologies for specialized film and foil formed packaging. Höfliger uses these special processes as modules within a complex total process.

Industry News
	Pharma Cautiously Adds Social Media To Marketing Plans
	Valeant Makes $76M Offer For Afexa
	ADVENTRX: Meeting With FDA On Three Pipeline Products
	American Airlines Cargo Expands Options For Shippers Of Temperature-Sensitive Pharmaceuticals
	Merck Millipore To Acquire Amnis Corporation
	Dual-Shaft Mixers Ideal For Viscous Applications
	$4.3M NIH Grant Gives Boost To HemoShear Predictive Drug Database
	Abbott Receives FDA Approval For ALK Gene Test For Lung Cancer Therapy Selection
View more headlines

Spotlight On Mixing And Blending
Brochure: Quadro Ytron® HV-Emulsifier
The Quadro Ytron HV can be optimized depending on the application and is available in two configurations: either as the HV-Emulsifier for submicron homogenizing, or as the HV-Wet Mill for micronizing suspensions and slurries.

Technical Brief: Mixing High-Solids Formulations
Mixer selection for high solids formulations depends on viscosity rather than percent solids. Regardless of solids concentration, low-viscosity mixtures can be prepared in single-shaft rotor/stator mixers or high-speed dispersers.

Application Note: Dry Granulation, Wet Granulation, And Direct Compression Tableting
The compressed tablet is one of the most widely prescribed oral solid dosage forms in use today.

Datasheet: Production Size IBC Blending Systems
Enhance quality control, increase product quality, and reduce production costs by implementing a SERVOLIFT IBC blending and material handling system.

Datasheet: G100 Pre-Weight Capsule Filler
G100 PRE-WEIGHT is a high-speed capsule filler which is ideal for dosing products for inhaling, with doses of 3 mg and above (without any compacting).
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Featured Multimedia

Video: FT4 Powder Rheometer — FT4 Dynamic Flow Mode
By introducing a dynamic method of measuring powder flow properties, Freeman Technology has made possible the direct comparison of flowability data for different powders. A program of continuing development makes today's FT4 Powder Rheometer, a sophisticated universal powder testing system that is helping address a very broad range of powder processing challenges.