Pharmaceutical Technology Whitepaper Alert:
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Featured Whitepaper: Surety LLC
Podcast: Don’t Risk Losing “Ownership” of Your Research IP as You Move to an Electronic R&D Environment
Sponsored By: Surety, LLC
As more laboratories and R&D-dependent bio-pharma and life sciences organizations move to electronic lab environments, the need to protect Scientific Intellectual Property (trade secrets, formulas, ideas and collaboration) is paramount. But if you aren’t protecting the integrity of your research data within your lab management workflows, you risk losing ownership, revenue and potentially your business if you can't prove time of creation (“first-to-invent”) and authenticity. Surety hosted a podcast series with Michael Elliot of Atrium Research & Consulting and Timothy Carroll, Partner at Loeb & Loeb, LLP, discussing important topics that can improve your organization's IP data security and integrity.
Podcast discussions include:
• Data-level security controls that must be in place to protect Scientific Intellectual Property (IP) as the” lifeblood” of the organization
• The benefits of an electronic R&D environment
• How digital timestamp technology can act as “trusted witness” to protect the integrity and legally defend the authenticity and ownership of your IP.
Listen in to this three-part series to gain valuable insights into effective and affordable IP protection for your electronic lab environment.
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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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Low-Cost Equipment Sourcing... Are You Being Left Behind?
Sponsored By: EquipNet Inc
In order to drive down costs, leading manufacturers are turning to low-cost sourcing when upgrading their capital equipment. A growing share of companies' equipment supply now comes from overseas suppliers, the second-hand market, and redeployment of the company's own surplus assets. |
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The Economical and Process Benefits of Steam System Audits
Author: Dawn Cartwright Dukes
Sponsored By: Spirax Sarco
This technical whitepaper teaches how pure steam and clean steam must be produced to meet the needs of pharmaceutical manufacturing facilities. It also explanins how investing time and money in auditing and optimizing a steam system can pay off quickly, since the cost of energy, maintenance, and downtime are steadily rising. |
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Pharmaceutical Continuous Monitoring Options Compared
Sponsored By: Veriteq, a Vaisala Company
"Compliance, Risk and Cost of Ownership Comparisons for Pharmaceutical Continuous Monitoring—Wired, Wireless and Standalone Monitoring Instruments” compares lifetime costs of ownership and risks of non-compliance for monitoring methods. |
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Ibuprofen in Miniature Swine Plasma and Synovial Fluid
Authors: Larry Andrade, Adam Grenier, Amber Awad, Teresa Pekol
Sponsored By: Smithers Pharma Services
Ibuprofen is a non-steroidal anti-inflammatory drug indicated in the treatment of inflammatory conditions. To eliminate many of the adverse effects associated with ibuprofen therapy, a novel dosage form has been developed and tested in a miniature swine model. |
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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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EQMS Coexistence in an Enterprise Environment
Sponsored By: Sparta Systems
ERP and Quality Management Software Integration– Avoid the Pitfalls. EQMS Coexistence in an Enterprise Environment.
Many businesses wrestle with a concern about the extent to which they should repurpose existing applications for the function of managing quality systems processes. The question of how – or if – an organization’s ERP should be extended for use in the quality systems area is an important one. This paper explores macro-level trends in both the ERP and quality systems application spaces, and discusses key issues that should be considered by those currently faced with this question. |
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Analysis of Stickpack Packaging
Author: Paul Dupont
Sponsored By: Ropack
This whitepaper considers the benefits of stickpack to consumers and to pharmaceutical and nutraceutical firms. It also outlines the unique manufacturing requirements and what equipment features are critical to consider. |
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Procedure for Determining an Acceptable Daily Exposure under Risk-MaPP
Authors: Allan W. Ader, Robert G. Sussman, Tracy A. Kimmel, and Robert H. Ku
Sponsored By: SafeBridge Consultants, Inc.
From a product safety perspective, multi-purpose pharmaceutical and chemical plant manufacturing operations need to be able to adequately clean product contact surfaces, in order to prevent contamination from one product to the next. Contaminants may include active pharmaceutical ingredients (“APIs”), cleaning agents, decomposition products, synthetic intermediates, excipients, or other residues. Previous approaches in the pharmaceutical and biotechnology industries have been to establish safe or acceptable limits based on a percentage of the human therapeutic dose or of the lethal dose in laboratory animals. More scientifically supportable health-based risk assessment approaches have recently been issued by the International Society for Pharmaceutical Engineering (“ISPE”) under their Baseline Guide® Risk-Based Manufacture of Pharmaceutical Products (“Risk-MaPP”). The following paper describes the procedure employed to establish an Acceptable Daily Exposure (“ADE”) and the scientific rigor needed to establish defensible ADE values. |
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