Pharmaceutical Technology Whitepaper Alert:
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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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Helpful Hints for Better Aseptic Technique
Authors: John Ryan, Ph.D., Jill Mariano, M.D.
Sponsored By: Bionique Testing Laboratories, Inc.
Aseptic technique is a set of principles and practices used by cell culture workers to reduce the potential of unwanted microorganisms or other cell lines from being introduced into your cell cultures and sterile solutions. The following article offers practical advice and solutions to address the challenges of sterile cell cultivation. |
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Tracking Unnamed Microorganisms Using DNA Sequences
Authors: Melissa K. Ruch, Sara C. Polson, Jacqueline L. Miller and Douglas H. Smith
Sponsored By: Accugenix, Inc.
Using 16S rDNA sequences for tracking unnamed bacteria, instead of relying on the taxonomic name, is especially useful when only a genus name, or higher level taxa, can be assigned. |
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Quantitation Limit of Pharmaceuticals Determined by UV-Vis
Author: Matt Bunbenthal, Technical Writer, Fette America
Sponsored By: Shimadzu Scientific Instruments
Cleaning validation is essential in order to prevent contamination and cross contamination of pharmaceutical products. Introduced here is the determination of the quantitation limit for the Shimadzu UV-1800 spectrophotometer by absorption photometry. |
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Improving ADME Screening Productivity in Drug Discovery
Author: Darcy Shave
Sponsored By: Waters Corporation
In this application note, we demonstrate an accelerated method development approach using a Design of Experiments-based Quality by Design (QbD) methodology to develop HPLC and/or UPLC methods. Resulting methods are optimized for performance and robustness, ensuring success in final method validation and ultimately in method transfer. |
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Swab/Direct Combustion Carbon Analysis of Drug Residue
Sponsored By: Shimadzu Scientific Instruments
Cleaning validation for production equipment at pharmaceutical facilities is an important process to ensure quality control and safety. This application shows the quick, accurate measurement of carbon using a Total Organic Carbon analyzer. |
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A Tale of Two Thermals
Author: Scott Rouse
Sponsored By: SIERRA INSTRUMENTS, INC.
Sierra’s Core Technology White Paper Series is a four part series detailing the flow technologies that allow Sierra to offer a flow solution for nearly any gas, liquid and steam application. Part 1 focuses on Sierra’s two types of thermal mass flow technologies for gas mass flow measurement and control—Capillary Thermal & Immersible Thermal. |
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An Automated Workflow for Accelerated Development of Robust LC Methods within a QbD Framework
Author: Peter G. Alden, Dana Yurach, Warren Potts
Sponsored By: Waters Corporation
In this application note, we demonstrate an accelerated method development approach using a Design of Experiments-based Quality by Design (QbD) methodology to develop HPLC and/or UPLC methods. Resulting methods are optimized for performance and robustness, ensuring success in final method validation and ultimately in method transfer. |
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An Evaluation of UHPLC System Performance
Sponsored By: Shimadzu Scientific Instruments
UHPLC often provides run times of less than one minute with peak widths of less than 200 milliseconds. A variety of applications using small particle columns is presented to demonstrate the throughput and performance of the new Nexera UHPLC. |
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FT-NIR spectroscopy for biopharmaceutical applications
Sponsored By: ABB Analytical Measurement
FT-NIR is a powerful technique for real-time determination of multiple properties during biotechnology processes. We review technical aspects that can be addressed with state-of-the art instruments and provide application examples. |
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Fast Analysis of Vitamins in Dietary Supplements Using LCMS
Sponsored By: Shimadzu Scientific Instruments
Utilizing an ultra-fast LCMS with high-speed scan capability and high-speed data acquisition to achieve good linearity and repeatability, as well as accurate quantitative analysis of water-soluble vitamins in dietary supplements. |
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Maximize Tablet Press Productivity
Author: Matt Bunbenthal, Technical Writer, Fette America
Sponsored By: Fette
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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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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Technology Approach to Quality Management
Author: Mike Jovanis
Sponsored By: Sparta Systems
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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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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