Pharmaceutical Technology Whitepaper Alert:
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Featured Whitepaper: Surety LLC
Protect Your Scientific Intellectual Property for the Long Term
Can your electronic research IP records withstand a court challenge?
Sponsored By: Surety, LLC
As more pharmaceutical, bio-sciences and R&D-centric firms move to electronic lab environments, your digital scientific research, formulas and clinical findings are your scientific Intellectual Property. Protecting the integrity and legally defending the authenticity and ownership of such electronic data is critical to your organization’s long-term success. But if you are overlooking this protection in your lab management workflows, you risk losing patent ownership, revenue and consequently your business, if you can't prove authenticity and time of creation, hence your ownership, in a court of law.
This new whitepaper from IP Protection Leader, Surety, explores these concepts and requirements, and discusses how you can implement simple, cost-effective controls to achieve legally defensible scientific IP for the life of the research records. |
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Topical Dermatological Formulation Development – "Things You Should Know"
Sponsored By: Dow Pharmaceutical Sciences, Inc.
There are important issues to consider as you contemplate development of a topical dermatological product. You may already have experience with oral or parenteral products, but there are challenges and issues which are unique to development of topical formulations. |
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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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Is Your Virus Study Under Control?
Authors: Michelle Arvoy, Cynthia Ipach, Dr. Jeri Ann Boose
Sponsored By: Compliance Insight, Inc.
Viral Testing and Viral Clearance Studies are expensive and time consuming aspects of pharmaceutical manufacturing. Various types of control must be considered during planning and performance of viral studies, as well as during the evaluation of study results. This paper details key elements of control which support the assay and virus study design to ensure its validity and success. |
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AQUEOUS CRITICAL CLEANING: APPLICATIONS IN PHARMACEUTICAL MANUFACTURING
Authors: Malcolm McLaughlin, Theresa Dowds
Sponsored By: Alconox
This Guide to Critical Cleaning places a concise overview of our half-century of experience at your fingertips. From tablet presses to mixing tanks, Alconox detergents handle tough critical cleaning jobs—like removing insoluble coatings residues. The benefits of employing aqueous cleaning in pharmaceutical manufacturing are numerous. |
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Hot Melt Extrusion (HME) - nano-scale compounding developments
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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Rotary Tank Cleaning and Cost Savings
Author: Jacqueline DeBellis
Sponsored By: Gamajet Cleaning Systems, Inc.
Specific case studies on the benefits of rotary impingement and CIP optimization vs. the standard tank cleaning processes. Benefits include: increased revenue and production with drastic reductions of operating costs pertaining to tank cleaning. |
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Cold Water Granulation Using Pregelatinized Starch
Sponsored By: Grain Processing Corporation
Quality granulations can be made using only cold water as the binding solution and fully pregelatinized corn starch as the binder. Using Spress® B825 Pregelatinized Corn Starch NF in the manner described eliminates solution preparation and simplifies the granulation process which accelerates production resulting in cost reduction. |
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