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Featured Whitepaper
Large Pharma Protects IP Research Data and Streamlines “Signing & Witnessing” Process with Integrated, Third-Party Timestamping
Sponsored By: Surety, LLC
For this large pharmaceutical company, the legal protection of their intellectual property research data in their lab management workflows was questionable – they could lose ownership, revenue and potentially their business if they couldn’t prove time of creation (“first-to-invent”) and authenticity decades into the future. Learn how they integrated a simple, automated control to protect their scientific intellectual property, and streamlined their “signing and witnessing” processes for legal defensibility. Without such a control, the company could expose itself to lost IP claims, rejected patents, and ultimately lost revenue. |
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Maximizing Value of Mature Products
Author: John Carkner
Sponsored By: Pillar5 Pharma Inc.
Pillar5 Pharma Inc. has emerged as a new entry in the contract manufacturing arena. They are a relatively small Canadian based company, manufacturing for Canadian and global markets from a former Pfizer facility in Arnprior, Ontario. |
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Testing Strategies to Ensure the Viral Safety of Biological Products for Human Use
Author: Jeri Ann Boose, Ph.D.
Sponsored By: Compliance Insight, Inc.
The selection and viral testing of cell lines, tissues, and other raw materials, as well as viral testing of the product at appropriate steps of the production process, are two of three complimentary approaches toward achieving assurance that an acceptable level of viral safety has been achieved for a product. Key test methods include in vitro and in vivo testing, electron microscopic evaluation, retrovirus testing, molecular based assays (e.g., PCR), and antibody production testing. |
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What are Mycoplasmas?
Author: John Ryan, Ph.D., Jill Mariano, M.D.
Sponsored By: Bionique Testing Laboratories, Inc.
Who are these guys? First described over 100 years ago, mycoplasmas are the smallest-free living prokaryotes capable of self- replication. They remain one of the most prevalent and serious microbial contaminants of cell cultures. This article features a review of mycoplasma biology and the scope of mycoplasma contamination within biomedical science. |
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Probiotic is a Growing Trend in the Consumer Healthcare Industry and Signals Promising Market Opportunities for Pharmaceuticals
Author: Paul Dupont, Daphne Allen
Sponsored By: Ropack Inc.
While originally regarded strictly as a specialty market, probiotic supplements are now mainstream. According to LexisNexis, 231 probiotic products were launched in 2008, compared with 34 just three years prior. Distinguished medical journals are confirming the industry’s credibility by publishing an increasing number of clinical trials. And the popularity of probiotics can be measured by the $43 million in drugstore sales in 2008. LexisNexis reports that 75% of women are interested in getting a digestive system “makeover.” Notably, probiotics are characterized as “the vital healthcare concept of the 21st century,” in Probiotics – A Global Update of Market Trends & Opportunities. |
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Benefits Of Steam System Audits
Author: Dawn Cartwright Dukes
Sponsored By: Spirax Sarco, Inc.
A clean- or pure-steam system provides the correct quality and purity of steam within operating parameters. A steam-system audit is economically sound, improving operation, safety and environmental stewardship.
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Maximize Tablet Press Productivity
Author: Matt Bunbenthal, Technical Writer, FETTE America
Sponsored By: FETTE America
Tabletting: Increasing Output and Decreasing Downtime without the need for Conventional Dies. Unique Segmented Turret Assembly Demonstrates Real-World Results In Pharmaceutical Manufacturing. |
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Implementing PAT and QbD – real-time particle size measurement for the pharmaceutical industry
Author: Alon Vaisman
Sponsored By: Malvern Instruments Inc.
As the pharmaceutical industry implements PAT and QbD, their symbiotic nature becomes increasingly obvious. Both are catalysts towards the longer term goals of continuous operation and real-time release - the realization of a transformed way of working. This article reviews changing practice within the pharmaceutical industry using the example of real-time particle size analysis to explore the analytical solutions needed and the benefits they deliver. |
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ASKING THE RIGHT QUESTIONS ABOUT CARTRIDGE DUST COLLECTION
Sponsored By: Camfil Farr APC
Choosing the best cartridge dust collection system for a given application involves research and attention to detail. This article will review four key areas of investigation: compliance, problem-solving, reliability, and return on investment (ROI). By reviewing these topics with a knowledgeable equipment supplier and knowing the right questions to ask, the reader will be better equipped to make informed dust collection decisions. |
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Bulk Inspection of Tablets: Assuring Product Quality at Manufacturing and Packaging
Sponsored By: Symetix
Achieve new levels of product quality and inspection efficiency in the manufacturing and packaging of tablets. Learn the pros and cons of manual inspection, mechanical sorting, blistering, single-file optical systems and a new class of automated, bulk vision inspection systems. The latest technology is keeping pace with the increasing demand for top-quality products. Learn how it helps minimize risk, increase throughput and contain costs. |
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Debunking Myths About Buying Pre-Owned Equipment
Sponsored By: EquipNet, Inc.
In the new eBook, “Purchasing Reality Check,” EquipNet debunks common myths about buying pre-owned industrial. |
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Analysis of Soy Isoflavones in Powdered Extracts using the ACQUITY UPLC H-Class System
Author: Andy Aubin
Sponsored By: Waters Corporation
Successfully transfer the compendial HPLC method for the analysis of powdered soy isoflavones extract to a UPLC® method to achieve a faster solution that maintains data quality. |
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Performance optimization of ELSDs
Author: Timothy P. Reyburn
Sponsored By: Ticoscen Inc.
Wondering if your ELSD is working optimally or running at it's highest sensitivity? See what an ELSD expert with 25 years of experience recommends for your lab. |
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A Tale of Two Thermals
Sponsored By: Sierra Instruments
Part one of the three–part core technology white paper series discusses the principle of operations of capillary thermal and immersible thermal gas mass flow measurement technologies. Taken together, these two methods cover a wide spectrum of gas mass flow measurements typically found in industrial applications. |
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A Rapid Approach to the Confirmation of Drug Metabolites in Preclinical and Clinical Bioanalysis Studies
Author: Robert S. Plumb
Sponsored By: Waters Corporation
In this application note, we demonstrate how the Xevo TQ MS combined with the ACQUITY UPLC System enables rapid and high-quality collection of both quantitative multiple reaction monitoring (MRM) and qualitative full-scan MS/MS data without the need for long analysis times or repeat injections. |
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Cleanroom Garment & Accessories |
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Sterile Cleanroom Gowning Evolves to Help Minimize Contamination Risk
Author: Damon Larkin
Sponsored By: KIMBERLY-CLARK PROFESSIONAL*, KIMTECH* Brand
This paper addresses the importance of process protection in cleanrooms via the appropriate cleanroom suit. It provides an overview of the sterile cleanroom apparel category and defines key areas for improvement. It introduces a new concept for sterile cleanroom gowning to help minimize the problems associated with current technologies.
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