Newsletter | June 5, 2012

06.05.12 -- Track And Trace Missing From FDA Reform Act

Pharmaceutical Online Newsletter

In This Issue:

Featured Articles

What Cold Chain Logistics Providers Are Missing
By Chris Campbell, President, Business Launch Consulting Group
In an April 2010 article by Nicolas Basta, writing for Pharmaceutical Commerce, it was estimated that in 2011 $6.6 billion would be spent shipping temperature-sensitive biological materials to destinations all over the world, and that the demand for global cold chain logistics will grow at the same double-digit trajectory as the life sciences industry.


Connecting The FDA And Pharma/Biotech Industry
By Rob Wright, Life Science Leader magazine
Even with more than 8,800 employees and an annual budget of around $3.2 billion, the FDA’s task of protecting public health seems daunting, considering the complexity of products being developed by industry. Factor in other issues such as counterfeiting, terrorism, drug reimportation, and the globalization of drug discovery, development, and manufacturing, and you soon realize that working at the FDA is indeed quite a challenge.


Does Your ELN Or Lab System Have The Right IP Protection Controls?
By Jon L. Roberts, Ph.D., J.D. Senior Partner, The Marbury Law Group, PLLC
Just because the U.S. patent law changed from “first-to-invent” to “first-inventor-to-file” doesn’t mean that you don’t need to establish the authenticity of your critical research data. Now, more than ever, the need for proving your ownership and the authenticity of your digitally based research records is paramount.

Featured Downloads

Seamless Environmental Assessment Solutions From The Drug Development Experts
A quality environmental assessment (EA) package is a critical component of animal health and many other new drug product submissions. Not having the right data — or not starting EA investigations soon enough — is an often underestimated developmental risk.


Tracking Sterilized Products Using RFID Tags And Expanded Memory Capacity
This technical paper introduces Ferroelectric Random Access Memory (FRAM) RFID technology to support pending track and trace, serialization requirements. FRAM's tolerance for radiation proves effective in RFID situations employing X-rays, ultraviolet light, or gamma rays.


Covance Helps Make Critical Decisions In Preclinical Development Of Gene Therapy Product
A small biopharmaceutical company had a very aggressive timeline for the preclinical development of its gene therapy product due to milestone requirements from its large pharmaceutical partner, and they asked Covance to perform the biodistribution studies.


DSM CMO Expertise In Traditional Chemistries And Innovative Green Chemistry
DSM contract manufacturing services offer the technology and expertise to deliver sustainability and value via a broad range of traditional chemistries and innovative green chemistry.

Industry News

Track And Trace Missing From FDA Reform Act
Biostar Pharmaceuticals Provides Update Regarding Gel Capsule Safety Issues
FDA Warns About Counterfeit Version Of Teva's Adderall
Ranbaxy Announces U.S. FDA Approval Of CIP-Isotretinoin NDA
Diabetes Drug Could Be A Promising Therapy For Traumatic Brain Injury
Patients Dosed In Phase I Clinical Trial Of Oncology Drug Candidate ME-344
New Research Available On The Multibillion Dollar Transmucosal Drug Delivery And Systemic Nasal Sprays Markets
Codexis Announces Three-Year Extension Of Collaboration Agreement With Merck
MIT-Designed Cooler Preserves Tuberculosis Drugs, Records Doses
Container Closure Integrity Testing (CCIT) Systems To Be Featured At Achema
View more headlines

Bulletin Board

For Sale: High Quality Pharma Packaging Equipment

GoIndustry DoveBid is conducting a Private Treaty Sale of High Quality Pharmaceutical Packaging Equipment in Canovanas, Puerto Rico. The sale includes bottling lines, capsule filler/encapsulators, a bottle filling/packaging line and more. Learn more.

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Spotlight On ACHEMA

The Attraction And Challenge Of Continuous Manufacturing
This article looks at the potential benefits of continuous manufacturing, highlights the way analytical practice may need to change to support new manufacturing models, and discusses the need for techniques that support intelligent processing.

Achema Hall 4.2/Stand F62

100% Container Closure Inspection Of Freeze-Dried Drug Product In Quarantine
Lyophilization is a complex process that presents many manufacturing challenges, one of which is maintaining and monitoring the container closure integrity of the finished package.

Achema Hall 3/Stand B31

Continuous Pharmaceutical Dry Granulation And Direct Compression Tableting Processes
The compressed tablet is one of the most widely prescribed oral solid dosage forms in use today. Typically the ingredients which comprise the tablet blend include the active pharmaceutical ingredient (API) together with various excipients, which not only act as carriers for the drug compound, but which also enhance its therapeutic effect, or efficacy.

Achema Outdoor Area/Stand 1A27

Brochure: LOCK INSIGHT PH Metal Detector
The LOCK INSIGHT PH Metal Detector is highly resistant to vibration and has management software that clearly displays the detailed product profile needed to achieve perfect product setups.

Achema Hall 3/Stand A60

Sentinel Clear™ XT Brochure
The Sentinel Clear XT powered air purifying respirator system incorporates the most advanced technologies available, including a brushless long life motor, a lightweight lithium polymer battery capable of delivering 12 hours of operation on a single charge, and easy decon features.

Achema Hall 6/Stand A10

8 Ways To Reduce Tablet Manufacturing Costs
It's no surprise that in today's struggling economy, companies are facing budget cuts across the board. In an effort to help our customers address these challenges, we put together this list of 8 Ways to Reduce Tablet Manufacturing Costs.

Achema Hall 3.1/Stand J9
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Featured Multimedia

Fluid Air On The Challenges Of Solid-Dose Manufacturing
Tom Tappen from Fluid Air discusses the current challenges of solid-dose manufacturing. The industry is shifting from water-soluble to water-insoluble compounds; a real challenge from a processing standpoint. Tappen explains the Fluid Air challenge to provide equipment that can move that process along.

Featured Products And Services

High-Speed Headspace Inspection Machine
High-Speed Headspace Inspection Machine

Product Details
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Lighthouse Instruments

Light Induced Fluorescence (LIF) Sensor
Light Induced Fluorescence (LIF) Sensor

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Natoli Engineering Company, Inc.

Clinical Trial Support
Clinical Trial Support

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Marken

MACRO-PACTOR® Roller Compactor
MACRO-PACTOR® Roller Compactor

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Gerteis Maschinen + Processengineering AG

SIPAT (Siemens PAT Solution)
SIPAT (Siemens PAT Solution)

Product Details
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Siemens Industry, Inc.
Achema Hall 11/Stand C3

MicroActive Interactive Data Analysis Software
MicroActive Interactive Data Analysis Software

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Micromeritics Instrument Corporation

Kleenpak™ Sterile Disconnector
Kleenpak™ Sterile Disconnector

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Pall Life Sciences - BioPharmaceuticals
Achema Hall 5/Stand D34

FlexMoSys™ Flexible, Modular And Fully Integrated Solutions
FlexMoSys™ Flexible, Modular And Fully Integrated Solutions

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Sartorius Stedim Biotech
Achema Outdoor Area/Stand 1 A17

UltraSnap™ Filter Assembly
UltraSnap™ Filter Assembly

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Meissner Filtration Products, Inc.
Achema Hall 5/Stand E5

AseptiQuik® DC Connector
AseptiQuik® DC Connector

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Colder Products Company
Achema Hall 9/Stand C20

Liqui-Cel® Membrane Contactors
Liqui-Cel® Membrane Contactors

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Membrana

Batch Weighing
Batch Weighing

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VAC-U-MAX