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Featured Whitepaper
Case Study: Leading Pharma Co. Protects IP and Streamlines “Sign & Witness” Process using Integrated, Trusted 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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Overcoming the Skin Barrier by Chemical Enhancements
Author: Debanjan Das, John G. Augustine, Ph.D., and Marcel Langenauer, Ph.D.
Sponsored By: SP Formulations
Skin permeation and/or penetration enhancement is a daunting challenge for formulation scientists developing products for dermal applications. This paper discusses the passive or chemical methods for enhancing permeation of the skin for drug delivery. |
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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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Auditing the Viral Clearance Testing Laboratory
Author: Jeri Ann Boose, Ph.D., and Michelle Arvoy
Sponsored By: Compliance Insight, Inc.
This paper outlines the key elements that should be evaluated during a pre-qualification viral clearance audit. Development of this outline was based upon application of general GLP/cGMP concepts to the specific requirements of viral clearance. In addition to the suggestions made in this document, the viral clearance auditor should consider the specific needs associated with each individual viral clearance study to ensure that all study requirements are properly evaluated prior to study initiation. |
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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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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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Nano-Scale Compounding via Hot Melt Extrusion (HME)
Author: Charlie Martin
Sponsored By: Leistritz
Hot melt extrusion is emerging as a preferred manufacturing methodology for dosage forms. The high cost and limited availability of raw materials during the development phase has resulted in the need to process small amounts of API’s/excipients via extrusion to determine process viability. Experimental data is presented on a new twin screw extrusion device that can process as little as 20 to 100 gram micro-batches, as well as a scale-up path. |
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Delivering Repeatable, Linear, and Accurate Injection Volumes for UPLC and HPLC
Author: Tanya Jenkins
Sponsored By: Waters Corporation
The ACQUITY UPLC® H-Class System uses a flow-through-needle injector design to achieve the
largest injection volume range, maximize sample recovery, and provide precise injection performance.
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Sample Delivery Flexibility for Routine Analysis by UPLC and HPLC
Author: Tanya Jenkins
Sponsored By: Waters Corporation
The needle-in-flow path design of the ACQUITY UPLC® H-Class System's Sample Manager delivers high-precision injections with excellent sample recovery. This sample delivery system gives laboratories the flexibility of working with a wide range of either HPLC or UPLC® injections. |
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Controlling Airflow in Class II Biosafety Cabinets
Author: Jim Hunter, Mark Meinders, Brian Garrett
Sponsored By: Labconco Corporation
Maintaining constant airflows in biosafety cabinets have vastly improved in the last forty years. This White Paper points out these improvements by comparing motor changes, sensor usage and how we can now accurately control airflow volume even as the HEPA filters load into the cabinet. |
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Achieving a Perfect Induction Seal Every Time
Author: Ryan Schuelke
Sponsored by: Enercon Industries Corporation
Inspired by the rave reviews of Enercon's webinar: "Achieve a Perfect Seal Every Time". This graphically rich whitepaper provides all the basic and advanced setup, operating, and troubleshooting techniques required to ensure a perfect seal every time. |
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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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Technology Approach to Quality Management
Author: Mike Jovanis
Sponsored By: Sparta Systems Europe, Ltd.
The presence of software solutions in the quality arena has progressed gradually from a deployment of tactical point solutions to complete, enterprise-level solution offerings. |
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Cleanroom Garment & Accessories |
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Sterile Cleanroom Consumables Management
Author: Lynn Standard
Sponsored By: Berkshire Corporation
Whether manufacturing in an aseptic or sterile environment, it is critical to ensure that consumables will not compromise the environment or products. This article provides a general overview of methods of sterilization, standards & guidelines, validation techniques, and audit requirements for cleanroom consumables.
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Ethylcellulose Weight Variation and Microencapsulation"
Sponsored By: Eurand Pharmaceutical Technologies
This work evaluated the influence of variations in ethylcellulose (EC) molecular weight on the coacervation process, which is used to produce microencapsulated drugs. Eurand uses coacervation techniques in its Microcaps® microencapsulation technology, which exploits the process using different types of polymers (e.g. ethylcellulose, cellulose acetate phthalate, gelatin). |
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Vial Transfer Cart Design
Sponsored By: Schaefer Technologies, Inc.
This paper addresses that FDA has found several pharmaceutical companies not maintaining ISO class 5 (class A) conditions within transfer carts. Implementing a solution has not been a simple task. The author discusses an approach for designing a transfer cart that will satisfy ISO Class 5 (class A) requirements. |
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