| This Newsletter Is Sponsored By:
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SECURE-VIAL™ Delivery System
Catalent's SECURE-VIAL technology (patent-pending) represents an exciting evolution in the application of our Blow/Fill/Seal capability to injectable drug products. Benefits include:
- Enhanced quality and sterility assurance. Our vial is molded, filled and sealed using an advanced aseptic Blow/Fill/Seal process-minimizing exposure to the environment.
Download the product sheet for additional information.
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| Featured Articles | | Strategic Outsourcing: The Growing Trend In The Pharmaceutical Industry
By Max Horn, Managing Director, Vetter Pharma-Fertigung GbmbH & Co KG
Over the last few years, the licensing standards of regulatory authorities have grown increasingly strict and, with global competition, cost pressures have intensified. The need for specialized knowledge and improved quality control, coupled with soaring process costs, are driving many pharmaceutical companies to rethink their strategies.
| | The Driving Force Of Technology
By Michael McGrath and Tom O'Leary, ICON Clinical Research
A recent industry roundtable, hosted by ICON, reinforced the general industry view that the use of technology is one of the backbones of clinical research studies. Participants not only agreed that technology is becoming widely adopted in clinical trials, but that there are some very clear and distinct drivers fueling this adoption.
| | Technical Transfer Of Manufacturing Processes From Client Sites To A Contract Manufacturing Organization
By Nigel Shipston, Angel Biotechnology Ltd.
There is an increasing need for the services of contract manufacturing organizations (CMOs) that can provide cGMP facilities combined with the specialist development and manufacturing expertise required to undertake biopharmaceutical production and preparation of appropriate documentation.
| | Strategies For Choosing An Outsourcing Provider
By Judy Carmody Ph.D., President, Avatar Pharmaceutical Services Incorporated
The trend of pharmaceutical companies increasing the rate at which formulations are moving through development is continuing. This pressure to produce comes from the financial expectations of revenue growth for pharmaceutical companies and the fact that genomics information has increased the number of potential targets.
| | Scientific Expertise Delivers Savings To Your Bottom Line
By Baxter BioPharma Solutions
Expedited transfer to a new production site was needed for a commercially launched lyophilized drug. Time lines were critical, as production could not continue at the original manufacturing location, and inventory levels were running low. |
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Featured Sponsor
Norwich Pharmaceuticals
Norwich Pharmaceuticals provides a complete range of enhanced services and capabilities meeting full life cycle pharmaceutical outsourcing needs from clinical trial to commercial launch and is one of the first to utilize the SupplyScape Corporation's Nexus supply chain solution. Download the company brochure for additional information. |
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| Spotlight On Contract Manufacturing
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Product Sheet: Steroid APIs And Intermediates
Continued focus on new process and product development — especially in the areas of respiratory therapy, women's health, dermatology, and oncology — underscores Pfizer CentreSource's long-term commitment to the field of steroid APIs and intermediates.
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Product Sheet: Prefilled Syringes
Prefilled syringes (PFS) have a lot of advantages over conventional containers for drugs for injection and enjoy excellent market acceptance. Sales of PFS have been growing at rates in the double digits for the last few years, partly driven by the introduction of increasing numbers of biotech drugs.
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Product Sheet: Fill And Finish Manufacturing
DSM Pharmaceuticals is a leader in the field of fill and finish dosage form manufacturing, with world-class capabilities in the areas of aseptic filling, lyophilization, and technology services.
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Product Sheet: Pharmaceutical Product Development
PharmEng contract pharmaceutical development services offer formulation and analytical development, clinical trial material manufacturing, and scale-up services for new drugs being developed for the marketplace.
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Product: Manufacturing
Contract Pharmacal uses high-speed, state-of-the-art processing equipment for on-time delivery and consistent batch results. Since 1971, CPC has been the company behind your brand — helping you bring world-class products to consumers around the globe.
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Product Sheet: Vetter Commercial Manufacturing
Concentrate and focus your resources. Leave the details of production to us, your specialist and loyal partner. Vetter Commercial Manufacturing can handle everything for you — from the initial stages of sterile through the custom-packaging of your final product.
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| Featured Downloads | | Product Sheet: OpX Guide
A perfect storm of business conditions is changing drug manufacturing. Enabled by the FDA's new guidance on PAT, OpX lets you chart a course through that storm to improved profitability.
| | Product Sheet: Plastic Bottles — Widemouth
In business for almost a century, Penn Bottle And Supply Company has been an innovator in packaging trends, originally involved in the recycling and delivery of glass bottles. Suitable for a multitude of applications, most items are readily available from stock in any of Penn Bottle's distribution centers.
| | Product Brochure: Thermatel® Sanitary Model TD2 Flow And Level Switch
Designed for use specifically in the clean, sanitary, or hygienic process industry, the Thermatel TD2 is an outstanding flow/level switch where easy external wipedown and a sensor free of cracks and crevices are required.
| | Product Sheet: Aptuit INDiGO™
Aptuit INDiGO accelerates early drug candidates, even those that are poorly bioavailable, into the clinic by reducing time from API to regulatory submission (IND CTA) to as little as 26 weeks under certain circumstances.
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| Featured Multimedia |
Video: Steam-Thru® II Connections | | The innovative design of the Colder Products Company Steam-Thru II Connections allows a quick and easy sterile connection between biopharmaceutical processing equipment and disposable bag and tube assemblies. The patented, three-port design allows steam to pass directly through the lower ports to "steam on" to stainless equipment.
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| Bulletin Board | | Don't miss your complimentary subscription to Life Science Leader. Here is just one of the topics covered in our February issue:
To stay competitive, companies in the pharma and biopharm industries need to implement practices that will cut costs and increase ROI. Life Science Leader covers the latest trends in Lean Manufacturing. Find out how these investments can improve your operations — click here to subscribe or click here to view the pilot issue..
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| Pharmaceutical Online Welcomes Its Newest Supplier | | Don't miss the newest Pharmaceutical Online storefront: |
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| Stay tuned for more new suppliers in future Pharmaceutical Online newsletters.
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Workshop: Principles And Practice Of Freeze Drying
January 14 to 16
University of Connecticut
Storrs, CT
Applying ICH Q10: Pharmaceutical Quality System
January 26 and 27 (Philadelphia, PA)
January 29 and 30 (San Francisco, CA)
Active Pharmaceutical Ingredient (API) And Drug Product Specification
January 26 to 28
Costa Mesa, CA
INTERPHEX Puerto Rico
January 29 and 30
San Juan, Puerto Rico
Pharmaceutical Freeze-Drying
February 9 to 11
Orlando, FL
HORIBA "Boot Camp" User Training Course: LA Series Particle Size Analyzers
February 10 and 11
Irvine, CA
PTX West
February 10 to 12
Anaheim, CA
Pittcon 2009
March 8 to 13
Chicago, IL
INTERPHEX 2009
March 17 to 19
New York, NY
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| Submit Content For This Newsletter | | Pharmaceutical Online invites members of the pharmaceutical manufacturing community to submit their technical articles, application notes, white papers, tutorials, videos, press releases, and other relevant content for featuring on www.pharmaceuticalonline.com and in our e-mail newsletter. Please send your submissions or questions to us at editor@pharmaceuticalonline.com.
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The Levelflex M is used for continuous level measurement of liquids. Measurement is possible even when there is very turbulent surfaces or foam. 
The TOC-VW is the most powerful wet chemical TOC on the market, capable of measuring down to 0.5 ppb of TOC and up to 3000 ppm. 
The Quality Control department at Confab Laboratories is responsible for the management of all control systems set up to ensure integrity of manufactured products. 
Eukerdruck offers a quality product which satisfies pharmaceutical manufacturing's stringent requirements and standards to ensure that strict quality targets are met in the area of packaging. 
Micro-90 is a mild, yet powerful multipurpose, alkaline cleaner that has long been used for laboratory cleaning, industrial applications, and critical cleaning processes. 
The Per-Fil Model PF-28RCM is an automatic, rotary continuous motion filling system. Its modular design allows for high-speed filling of powder and granular products. 
From API and formulation sourcing to manufacturing, scale-up, and packaging, Camargo provides its clients with invaluable strategic guidance and management services. 
The Synthos 3000 is a high-performance microwave instrument for organic synthesis. It guarantees direct scaling up for experiments from small batch sizes (e.g. 4 mL) up to liter volumes. 
All Advanced Scientifics polyethylene film products are compliant with the following: ISO 13485:2003 certified, cGMP manufacturing regulations, Class 10,000 certified clean room, and FDA registered. 
EP Series is a solution for the centralized GLP-compliant management, analysis, simulation, and reporting of PK/PD laboratory data in drug development. 
INTERPHEX Puerto Rico Booth 1535
The Micromeritics Gemini V Series of surface area analyzers utilizes a patented twin-tube design which assures fast and accurate dosing of the adsorptive gas without pressure overshoot. 
This system handles a wide range of tablet types. Applicable shapes include round, triangular, and other (certain special tablets shapes can be optionally added). 
Over the past several years, Electrol Specialties has reintroduced an old technology to address a common problem associated with Clean In Place (CIP) — constant maintenance associated with chemical feed pumps. 
The FT4 Powder Rheometer is a universal powder tester that can measure a wide range of powder properties. It is also a useful tool for studying many powder processability issues. 
The HIAC 9705 sets new standards for accuracy and efficiency in the detection of liquidborne particles in final and intermediate products and in WFI/PW/DI waters. 
Lyostat 2 is a fully integrated freeze-drying microscope that enables critical events to be observed in situ and characteristics to be observed and identified. 
MULTIJECTOR® Vacuum Pumps have been established in many applications and their high reliability has helped achieve specified duties in several applications. 