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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Automated Audit Management: Mitigate Risk and Increase Productivity
Sponsored By: Sparta Systems
Today’s best-in-class enterprises are moving from manual, disparate and siloed audit management to centralized and automated audit management solutions. This whitepaper describes how audit management solutions enable life science companies to reduce audit time and cost, mitigate risk and ultimately help improve product quality and safety. |
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Risk Evaluation and Mitigations Strategies and the FDAAA
Author: Debra Norman, Ph.D., JD & Gary Hindman, Ph.D.
Sponsored By: Beckloff Associates, Inc.
On March 25, 2008, new legislation designated as the Food and Drug Administration Amendments Act of 2007 (FDAAA; “the Act”) took effect, which directed FDA to develop a systematic, scientifically sound approach to managing the risk-benefit ratio of a drug throughout its lifecycle, with an explicit focus on postapproval safety. In September 2009, FDA announced a draft guidance to assist sponsors in the preparation of a REMS. The guidance provides links to a number of resources available at FDA to aid in REMS preparation. |
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Development of an Enteric Coating Process and Stability Evaluation of PCcaps®
Authors: Balaji V. Kadri, Aran M. Johnson, Danica M. Cartwright, Ken Lo, Mark A. Cappucci & Paul F. Skultety
Sponsored By: Xcelience, LLC
Enteric coating of capsules enables innovators to overcome challenges of acidic degradation and dyspeptic side effects associated with some compounds. This whitepaper provides an evaluation of the ability of commercially available enteric, aqueous film-coating systems to confer their enteric release properties on gelatin capsules in support of pre-clinical rodent studies. |
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Optimize your ELSD for best performance
Author: Timothy P. Reyburn
Sponsored By: Ticoscen, Inc.
In this whitepaper from the Evaporative Light Scattering Detector servicing experts, Ticoscen Inc. provides some basic optimization tips. |
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SAXS Study on Microemulsions
Authors: Jens Rieger, BASF Gesellschaft
Sponsored By: Anton Paar USA
Microemulsion are thermodynamically stable dispersions of one liquid phase in another, stabilized by an interfacial film of surfactant. In addition to droplet models (oil-in-water or water-in-oil emulsions) for the description of the microemulsion structure models of fluctuating domain structures have also been proposed. The size of these domains is in the range conveniently accessible with the SAXS. Microemulsions can be used as a medium for phase transfer catalysis, in formulations of lubricating fluids in pharmaceutical or cosmetic applications. |
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Provide Precise, Seamless Liquid Filling
Sponsored By: Thermo Fluid Handling
Sterile liquid flow is paramount in pharmaceutical and bioprocessing applications, which is why Thermo Scientific Masterflex peristaltic pumps are highly-suited for these demanding processes. |
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Asset Accuracy: Know What You Have and What It’s Worth
Sponsored By: EquipNet
You’ve spent millions--or even billions--of dollars equipping your state-of-the-art facilities to become a leader in your industry. And it was a smart investment! Those assets are a necessary ingredient to your company’s recipe for success, but their full value depends on your asset accuracy. Do you know what you have and what it’s worth? |
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LEV: What You Need to Know Before Selecting and Installing Dust Control Systems
Authors: Max Roman, Ph.D.
Sponsored By: Kleissler PC. LLC
Meeting strict standards for low exposure levels of dust generated in the processing of materials is a challenge faced in the manufacture of Pharmaceutical products. This paper outlines critical engineering parameters for local exhaust ventilation (LEV) that are essential to meeting these standards. Special emphasis is given to the design of dust containment hoods which capture the dust at the source of emission. |
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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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