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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Overcoming the Skin Barrier by Chemical Enhancements
Authors: 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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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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Is Your Virus Study Under Control?
Authors: Michelle Arvoy, Cynthia Ipach, Jeri Ann Boose, Ph.D.
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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Ion Exchange Chromatography Method Development on ACQUITY UPLC H-Class Bio System
Author: Paula Hong
Sponsored By: Waters Corporation
The ACQUITY UPLC H-Class Bio System and Auto•Blend Plus Technology help IEX users streamline the
development of methods for the analysis of proteins and their charge variants.
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Controlling Airflow in Class II Biosafety Cabinets
Author: Jim Hunter, Senior Project Engineer; Mark Meinders, Product Manager; Brian Garret, Product Specialist
Sponsored By: Labconco Corporation
The process of “teaching” the ECM to deliver constant airflow volume in a Class II biosafety cabinet is a patent-pending process developed by Labconco, called the Constant Airflow Profile (CAP). |
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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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Reliability of Size Exclusion Chromatography Measurements on ACQUITY UPLC H-Class Bio System
Author: Paula Hong
Sponsored By: Waters Corporation
The ACQUITY UPLC H-Class Bio System along with an ACQUITY UPLC BEH200 SEC Column deliver reliable and reproducible SEC separations for biomolocules. |
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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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Designing a Pharmaceutical Grade Dry Material Feeder
Sponsored By: Schenck AccuRate
The pharmaceutical manufacturing environment creates unique design requirements for process machinery being utilized in that setting. This paper discusses the necessary steps taken by a process machinery manufacturer to develop a dry material feeder specifically engineered for the pharmaceutical industry. |
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Benefits Of Steam System Audits
Author: Dawn Cartwright Dukes
Sponsored By: Spirax Sarco, Inc.
A clean- or pure-steam system provides the correct quality and purity of steam within operating parameters. A steam-system audit is economically sound, improving operation, safety and environmental stewardship. |
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Integration of Vial Filler and Lyophilizer in the same Isolator
Author: Gary Partington
Sponsored By: Walker Barrier Systems
Rather than providing an isolator for the lyophilizer and fillmachine, this approach looks at combining the two process machines into a single isolator. Result saves space and dollars. |
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Addressing the Challenges of Complaint Handling
Sponsored By: Sparta Systems
This white paper outlines the challenges of complaint handling and common obstacles faced by life sciences companies in this area. The paper highlights how quality management solutions can improve compliance, product safety and workflow performance. |
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Linking CQAs to CPPs in Life Science Manufacturing
Authors: Randy Tatlock, Senior Application Specialist, Aegis;
John Helfrich, Vice President, GMP Automation Programs, VelQuest Corporation
Sponsored By: Aegis Analytical Corp
You’ve identified CPPs & CQAs in your process. Link them unequivocally with cause & effect analysis. Watch our webcast and explore best practices for understanding relationships between CPPs & CQAs. |
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Binders in Tablet Manufacturing
Author: Arnis Aistars, Ph.D
Sponsored By: Spectrum Chemical Mfg. Corp.
This whitepaper presents a review of commonly available binders with an examination of their features, advantages, and benefits for pharmaceutical tablet manufacturing. |
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Moisture Activated Dry Granulation using Starch
Authors: Carrie Shipley, Susan Freers
Sponsored By: Grain Processing Corporation
Using pregelatinized starch as the absorbent diluent in the Moisture Activated Dry Granulation (MADG) process, combinations of maltodextrin and povidone were tested to determine optimum binder level. |
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Cleanroom Garment
& Accessories |
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Donning by Design
Author: Damon Larkin
Sponsored By: KIMBERLY-CLARK PROFESSIONAL*, KIMTECH* Brand
This paper addresses the importance of process protection in cleanrooms via the appropriate cleanroom suit. It provides an overview of the sterile cleanroom apparel category and defines key areas for improvement. It introduces a new concept for sterile cleanroom gowning to help minimize the problems associated with current technologies. |
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