Newsletter | May 8, 2012

05.08.12 -- Feds Crack $70 Million Eli Lilly Drug Heist Case

Pharmaceutical Online Newsletter
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In This Issue:

 

Biomanufacturing "Out Of The Box"

Biomanufacturing "Out Of The Box"

Sartorius Stedim Biotech’s well-established, single-use and reusable product portfolio and G-Con Manufacturing’s novel, modular, mobile cleanroom “pods” combine to provide an unparalleled set of cost-effective, “plug and play” tools for next-generation biomanufacturing.

Each FlexMoSys™ pod meets the need for manufacturing capabilities for antibodies, vaccines and other recombinant proteins. This production capacity is fast, fully integrated and ready-to-use.

FlexMoSys™ represents “the Combination of Complementary Expertise for the Next Generation of Flexible, Single-Use Manufacturing Concepts.” Learn more.

Featured Articles

Single-Use Connections Enable Advancements In Aseptic Processing
By John Boehm, Colder Products
Today's market demand for new drugs, combined with the difficult economic environment, is challenging bioprocessors to review their manufacturing systems and seek ways to make them more flexible, reliable, and cost-effective.


Delivering Traceability In The Pharmaceutical Supply Chain
By Donna Criswell, International Business Systems
The distribution of counterfeit medicine is one of the pharmaceutical industry’s biggest threats. It is believed that 7% of all medicines worldwide are counterfeit. The figures become even more shocking on a regional basis, with 40% in South America and nearly 70% in West Africa being counterfeit.


Management Of Fluid Transfer In Single-Use Systems
By Chris McBride and Donna Riedman, Pall Life Sciences
When designing a single-use process containing many unit operations, the initial focus of attention is often the compounding and purification steps involving process equipment such as bioreactors, mixers, tangential flow filters for concentration/diafiltration, and direct flow filters for particle or bioburden reduction or sterilization.

Featured Downloads

TepoFlex®Biocontainer Assemblies Standards Guide
The One-Touch® single-use systems portfolio is built on a solid foundation of quality, technical capability, and operational excellence, which is unparalleled in the industry.


Why Serialize Now?
There is no doubt that your company has implemented a large-scale ERP system to streamline your enterprise, but where does that system fall short? Are all of your machines and points of data entry set up properly to communicate directly with the ERP?


Choosing The Right Temperature Monitoring Solution
Globally, pharmaceutical regulators are becoming attuned to cold chain issues as biologics, vaccines, and other temperature-sensitive products are commercialized. Many recommend including temperature monitoring technology in every cold chain shipment. 


Glossary Of Multivariate Statistical Methods
Multivariate data analysis (MVA) can be complicated, especially for people new to the field, so we've put together this handy glossary, written by world leading experts with many years experience in MVA.

Industry News

Feds Crack $70 Million Eli Lilly Drug Heist Case
AmerisourceBergen Acquires World Courier Group
Mylan Announces Settlement Agreement For Generic Nuvigil®
New Myeloma Drug Waiting For FDA Approval
Isis Initiates Phase 2 Study Of Hypertriglyceridemia Treatment
Call For Speakers Now Open For Life Sciences Cloud Consortium
AMRI Launches SMARTSOURCING™ For Contract Manufacturing And Research Services
Bosch Presents Pharmaceutical Equipment For Inspection, Coating, Filling And Closing
FDA Permits Marketing Of A New Device For Abdominal Surgery
Norwich Pharmaceuticals Announces Significant Business Growth
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"Advances In Pharmaceutical Processing" (Complimentary Technical Seminar)

"Advances In Pharmaceutical Processing" (Complimentary Technical Seminar)

One-day course examining a wide variety of important pharmaceutical processing topics and trends. Seminar offers an objective technical overview and introduces participants to methods of both improving current operations and utilizing new process technologies. Course material is suitable for scientists, engineers, production and manufacturing personnel, researchers, formulation scientists, product development and process transfer personnel.

May 22, 2012: POINTE-CLAIRE, QUEBEC, CANADA
May 24, 2012: RESEARCH TRIANGLE PARK, NORTH CAROLINA, USA
Online Registration Form

SPONSORS: ProSys, K-Tron, ChargePoint, FPS (Food Pharma Systems), Quadro, and Fitzpatrick
Learn more: Download Seminar Flyer (PDF)

Spotlight On Single-Use Technology

Datasheet: Single-Use, Stainless, Folding, Intermediate Bulk Containers
Our stainless folding IBC container is the best choice for food, pharmaceuticals, cosmetics, beverages, and nonhazardous chemicals.

Product Sheet: Prevas Single-Use Dosing Systems
Prevas is the first completely preassembled, presterilized, and prevalidated dosing system available for the clinical and production pharmaceutical and biotech filling market. This allows risk-free scale up of filling operations in a single-use format.

Achema Hall 3.1 / Stand C70

Brochure: High-Purity Diaphragm Valves
Aquasyn does not offer just an industrial diaphragm valve that has been converted to meet industry requirements, but products which are conceived and executed specifically to meet the needs of the biopharmaceutical industry.

AseptiQuik® DC Connector Datasheet
AseptiQuik DC connectors are the first all-in-one, single-use connection technology to offer both a sterile connection and a sterile disconnection.

Extractables Analysis Of Flexel® Bioprocessing Bags Filled With SAFC Solutions
Flexel bags are designed for the preparation, storage, and transport of biopharmaceutical solutions. They are used in many single-use applications, such as storage and transport of buffers, chemical solutions, cell culture media, intermediates, and bulk drug substances.

The Flexible Factory Concept
As manufacturing and facilities managers confront this changing world, they are still tasked with meeting today's capacity needs. Many are turning to a new flexible factory platform that will accelerate their deployment of new biomanufacturing capacity while lowering risk, increasing speed, and reducing capital costs.
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Featured Products And Services

Acsis ProducTrak Mobile
Acsis ProducTrak Mobile

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Acsis Inc.

Temperature Recorders
Temperature Recorders

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ShockWatch

Clinical Trial Support
Clinical Trial Support

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Marken

Standard Laboratory Glassware Washer: G 7883 CD
Standard Laboratory Glassware Washer: G 7883 CD

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Miele Professional

Asep-Tech® Model 628 Blow/Fill/Seal Packaging Machine System
Asep-Tech® Model 628 Blow/Fill/Seal Packaging Machine System

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Weiler Engineering, Inc.

Celphere: Microcrystalline Cellulose Spheres
Celphere: Microcrystalline Cellulose Spheres

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Asahi Kasei

Used High-Shear Mixers
Used High-Shear Mixers

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Federal Equipment Company

Clinical Trial Cold Chain Logistics
Clinical Trial Cold Chain Logistics

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World Courier Inc.

Biologic Filling
Biologic Filling

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JHP Pharmaceuticals

Envirotainer® Container CLD
Envirotainer® Container CLD

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Envirotainer

CFM 3101 Pharmaceutical Vacuum
CFM 3101 Pharmaceutical Vacuum

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Nilfisk Industrial Vacuums

MINI-PACTOR® Roller Compactor
MINI-PACTOR® Roller Compactor

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Gerteis Maschinen + Processengineering AG