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It's here! A sneak peek at Life Science Leader magazine.
Life Science Leader brings the latest trends, topics, and expert opinions throughout the life science industry to you. This essential business tool focuses on informing decision makers of today's key issues so they can implement best practices in their organizations. Don't miss your chance to receive your complimentary subscription — click here to subscribe or click here to view the pilot issue.
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Understanding Powders
By Tim Freeman, Director of Operations, Freeman Technology
Effective powder processing underpins almost all pharmaceutical manufacture. The majority of actives are delivered in powder form, as tablets or suspensions, or by dry powder inhaler for example, and even those that aren't are commonly handled as powders at some point during production. A good understanding of powder behavior is therefore essential to implement a knowledge-based approach to development, as advocated by QbD.
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| Featured Articles | | Successful CMO Selection
By Patricia M. Seymour, Howard L. Levine, and Susan Dana Jones, BioProcess International
Outsourcing of biopharmaceutical product manufacturing has grown significantly in the past several years, and the trend is predicted to continue. Of several explanations why this growth in outsourcing has occurred are increases in the number of biopharmaceutical products being developed and commercialized as well as the availability of highly qualified contract manufacturing organizations (CMOs).
| | Comparing Efficiencies Of 0.1 µm Rated Membranes
By Mar Cor Purification
There are a number of 0.1 micron filters commercially available today. These filters remove particulates and microorganisms and are used in a wide range of industries and applications. Although these filters are rated as 0.1 µm, it is difficult to differentiate between these filters regarding particulate retention capabilities.
| | Guidelines For Pharmaceutical Stability Testing
By Microbac Laboratories, Inc.
Stability testing is the primary tool used to assess expiration dating and storage conditions for pharmaceutical products. Many protocols have been used for stability testing, but most in the industry are now standardizing on the recommendations of the International Conference on Harmonization (ICH).
| | Contract Manufacturers Of Potent Products Actively Seeking Flexible Containment Systems To Increase Safety And Profitability
By Alan E. George, ILC Dover
The interest in the use of containment for the development and manufacture of active pharmaceutical ingredients (APIs), including sensitizers by contract manufacturers and contract research organizations, is expanding.
| | Performance Testing Of Rare Earth Magnetic Tube Circuits
By Eriez
The purpose of the research is designed to determine which commercial tube magnets will provide the greatest opportunity to remove dangerous ferrous metal and weakly magnetic contaminants from process flows in industrial applications. |
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Featured Sponsor
Submit Content For Pharmaceutical Online The Magazine
Share your knowledge and experience with attendees of INTERPHEX 2009 and other pharmaceutical manufacturing and engineering professionals by contributing an article to Pharmaceutical Online The Magazine. Contributing an article to The Magazine provides an opportunity for you and your company to be positioned as industry experts. Click here to view submission guidelines. Please send questions or submissions to solutionsupdate@pharmaceuticalonline.com. |
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| Spotlight On Contract Services And Testing
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Product Brochure: Product Development — Pharmaceutical Services
AAPS Booth #1501
When you work with Catalent, you gain access to the strongest set of analytical chemistry resources available to the pharmaceutical and biotechnology industries. Catalent's scale, infrastructure, and scientific expertise allow them to solve your most difficult analytical challenges — and deliver unique value to your product.
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ICON Corporate Brochure
ICON is a global company, with experience in the world's most important regions for clinical research. They specialize in the strategic development, management, and analysis of programs that support clinical development — from compound selection to Phase I-IV clinical studies.
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Product Catalog: Xcelience 2008 Equipment List
Xcelience is an independent formulation development company, providing customized global solutions to the biotechnology and pharmaceutical industries. This catalog provides a comprehensive list of the equipment available from Xcelience to assist your company in delivering your product to market.
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Ropack Company Brochure: Contract Manufacturing And Packaging Services
From formulation development to the pick-up of your packaged products, Ropack ensures the quality you require within agreed deadlines. Whether your packaging needs must be tailored to a specific group, fall under particular circumstances, or require outstanding precision, Ropack is always ready to offer solutions at competitive prices.
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Corporate Brochure: Cirrus Pharmaceuticals
AAPS Booth #1854
Cirrus Pharmaceuticals, Inc. is a contract product development company that works with start-up, midsize, and multinational biotechnology and pharmaceutical companies on small molecule, peptide, and protein drug product development projects.
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Product Sheet: Micromeritics Analytical Services
AAPS Booth #1961
Selecting the appropriate particle size technique is not as easy as it may at first seem because there is no single measurement that is appropriate for all materials and applications. Micromeritics Analytical Services currently has available seven different techniques for measuring particle size.
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| Featured Downloads | | Product Brochure: HIAC 8103 Liquid Particle Counting System
The HIAC 8103 system is a versatile system for use in parenteral particle counting of SVI and LVI for USP <788>, JP, and EP, and precision cleaning applications. The HIAC 8103 system is easy to use, reduces sampling costs and uses proven particle counting technology.
| | Brochure: 505(b)(2) — Who Says You Can't Teach An Old Dog New Tricks?
AAPS Booth #440
The 505(b)(2) submissions have special requirements; you need the experts at Camargo to guide you through the process. The Camargo team has years of experience in the full spectrum of drug development — not to mention a thorough understanding of the FDA and its evolving standards.
| | Product Brochure: SPS Pharma Services — Contract Research Organization
AAPS Booth #1637
With more than 30 years of experience and innovation, SOTAX has manufactured the instruments needed by industry to develop a better understanding of dissolution. Now, SOTAX offers a unique contract research organization based solely on dissolution.
| | Product Sheet: Nikka Densok Pinhole Inspector HDI Series
The Nikka Densok HDI Series Pinhole Inspector is designed to inspect Blow Fill Seal (BFS) containers for possible liquid leakage in either strip form or as individual containers. The HDI Series Pinhole Inspector can be integrated into any production line for 100% inspection.
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| Bulletin Board | | Webinar: X-Ray Inspection In The Food And Pharmaceutical Industries
November 19, 2:00 pm EST
This webinar will cover the basics of x-ray inspection technology and its application in a manufacturing environment. You will learn what it can do and, equally important, what it cannot do. It will also cover the very important issue of safety and how you can incorporate x-ray inspection into your HACCP and GMP brand protection programs. Click here for additional information and to register.
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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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Webinar: DSMBs, Endpoint Committees, And Adaptive Trials — Synergy, Technology, And Innovation
November 13
2008 AAPS Annual Meeting And Exposition
November 16 to 20
Atlanta, GA
Powder Flow And Process Analytical Technology (PAT) Tools For Implementation Of QbD
November 17
Atlanta, GA
Comprehensive Overview Of FDA Regulatory Compliance For Drugs And Biotech Products
November 17 and 18
Malvern, PA
Speed And Safety In Drug Discovery
November 26
London, England
European Antibody Congress 2008
December 1 to 3
Geneva, Switzerland
Selecting And Managing CROs
December 2 and 3
Malvern, PA
IBC's 4th Annual BMD Summit
December 8 and 9
Durham, NC
Effective Risk-Based Applications Of Drug cGMPs And Validation Requirements For Cosmetics And OTC Drug Products
December 8 and 9
Malvern, PA
Pharmaceutical Maintenance Management — Understanding cGMPs
December 8 and 9
Malvern, PA
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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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Precise Controlled Atmosphere Glove Boxes provide a leak-tight environment for work with contamination-sensitive materials. 
Natoli offers a variety of precision pharmaceutical metal detectors for analyzing and controlling product lines. All detectors are 21 CFR Part 11 compliant. 
Powered by Pilgrim's CAPA Management platform, Pilgrim Complaint Management provides a closed-loop mechanism that allows you to implement effective, timely resolutions to customer issues. 
The new, pioneer mixing concept of the Master Plant mixer guarantees for highest product quality and extreme shortening of production times. 
The Kramer Model E2000 Deduster is a tablet and capsule dedusting and conveying machine with an upward conveying range from 250mm to 1500mm and a stainless steel cylinder. 
Fully equipped to demonstrate full-scale production, pilot, and lab size equipment, the facility allows for first-hand evaluation and recording of trial results. 
The Silver Series Discharge Stations, manufactured by G2, are the highest quality and design available for the nutraceutical, food, and chemical industries. 
Niro Soavi supplies a range of pressure positive displacement pumps (High Pressure Pumps) suitable for handling the toughest of industrial applications. 
Three60 is a completely sanitary disposable method of removing a sample from a closed system. There are no parts that must be disassembled, cleaned, and reassembled. 
Licaps capsules are two-piece gelatin capsules that have been specially designed to be sealed for secure containment of liquids and semisolids. 
The MPU's twist-to-connect design features an easy-to-use locking mechanism that guards against accidental disconnects and provides a reliable, secure connection. 
With Blue Mountain Regulatory Asset Manager, calibration, maintenance, and validation professionals can finally collaborate within a single system without compromising productivity or compliance. 
Newark Wire Cloth is more than just a supplier of wire cloth, they are the weaver. Newark offers a broad range of wire cloth — Space Cloth, Mesh Cloth, and even Micronic Filter Cloth. 
Formulated using a pea peptone, VPB responds to the needs of pharmaceutical manufacturers who want to ensure that their production environments are not in contact with any animal-derived material. 
Servolift offers a whole host of configurations to suit every product and process such as: blending baffles, removable bin frames, casters, purge ports, and high containment valves and systems. 
The Silverson Disintegrator 2500 Mixing System will disintegrate, solubilize, or disperse the largest of solids — up to 40" across — in a single operation, and in times you wouldn't believe. 
The HC-8000 homogenizers produce up to 8,000 psi with standard lab air, for premium results at an affordable cost. 
With the introduction of the Integrated Custom Air Handler (ICA) line, Munters continues to be the only company in the Americas to develop and build the desiccant rotors that are the heart of an integrated desiccant air handling system. 