Pharmaceutical Technology Whitepaper Alert:
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Featured Whitepaper: Surety LLC
Not all ELN IP Protection Controls are Equal – What You Should Know as You Go Electronic
A Technology Comparative of “Digital Notarization” Solutions
Sponsored By: Surety, LLC
Using an electronic lab notebook (ELN) or planning to move to one? More laboratories and R&D-centric organizations are changing from paper-based to electronic workflows to remain competitive…and why not? From initial conceptualization through product development and production, ELNs and other lab informatics systems are efficient and effective for what they are designed to do.
The problem is, though, they lack certain defensibilities, particularly long-term, independent protection of the integrity and authenticity of your scientific intellectual property. So how can you ensure the safety and your ownership of your IP in a legal or regulatory dispute?
Many R&D organizations have turned to digital signatures and digital timestamping as solutions for IP protection. But not all are equal. You should be aware of the differences.
This new whitepaper from IP Protection Leader, Surety, examines four of the most common digital protection controls for research-based IP, providing a comprehensive “graded” evaluation of each, and painting a portrait of the bioscience community's various options for neutralizing potential patent and other “ownership” litigation. |
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EU Batch Testing and Product Release
Author: Birgit Schumacher, PhD
Sponsored By: SGS Life Science Services
The sale of medicines in the EU is regulated to ensure efficacy and safety. For medicines manufactured outside the EU/EEA, each product batch must obtain certification in the importing country. |
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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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Topical Dermatological Formulation Development – "Things You Should Know"
Sponsored By: Dow Pharmaceutical Sciences (Sterile Unit)
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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Risk-based Manufacture of Pharmaceutical Products: A guide to Risk MaPP approaches and experience
Author: Kim Ray
Sponsored By: OSO BioPharmaceuticals Manufacturing
A discussion of how Oso BioPharmaceuticals has successfully implemented scientific, risk-based approach to handling hazardous compounds, how it has impacted their clients, and the reaction of regulatory bodies. OsoBio will share how implementation of this approach has affected its business as well as its clients. |
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An Introduction to Pharmaceutical Forensics
Author: David Exline
Sponsored By: Gateway Analytical
Pharmaceutical forensics applies forensic expertise, analysis and problem solving principles address quality issues such nonconformance and deviation investigations, contaminant identification and source determination. This whitepaper provides an introduction to this approach and a case study example of particulate examination. |
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Competitive Edge
Author: Michael P. Trova, Ph.D.
Sponsored By: AMRI
International expansion of R&D organizations is driving career development and hiring trends. As a result of globalization associated with expanding international operations, there is a growing need for talent – principally with discovery and development skill sets – that may favor candidates who are willing to consider international assignments in non-traditional locations. |
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Considerations in Ophthalmic Formulation Development for Various Ocular Diseases
Author: Dr. Yunik Chang
Sponsored By: Dow Pharmaceutical Sciences
Discussion about ophthalmic formulation technology and the challenges for scientists and formulators who are interested in developing eye-care products. |
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Meeting tomorrow's US pharmaceutical training needs today.
Author: Mr Neil Wilkinson & Mr Jim Morris
Sponsored By: NSF-DBA (USA) LLC
As companies prepare their 2012 training budgets and employees begin selecting their preferred training courses, it’s time to see what new training is on the market in the US. NSF-DBA’s QLP modular course may be just the answer. |
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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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Monitoring Systems: Sorting out Wireless
Sponsored By: Vaisala
Monitoring systems for temperature, humidity and other parameters can be complex, involving hundreds of sensors in a variety of applications. One of the most important decisions in selecting or adding to a monitoring system is choosing the connectivity method that will allow the sensors to speak to a central processing unit. Decisions on connectivity are dependent upon several factors, including: data integrity requirements for regulatory purposes, logistical concerns such as access points for transmitters, and existing network infrastructures. In this article, we describe the most common wireless methods of connecting sensors to a monitoring system and offer eight considerations for selecting a method best suited to the application. |
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ROTRONIC's New Technology Reduces Calibration Time
Author: Greg Gowaski
Sponsored By: Rotronic Instrument Corp.
Maintaining the accuracy of your humidity and temperature instruments requires periodic calibration. Calibration of these instruments can be a costly and time consuming venture. ROTRONIC’s new AIRCHIP 3000 Digital technology greatly reduces calibration time and cost by eliminating one full calibration cycle. |
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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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The Benefits of Developing a Pre-Demolition Strategy
Sponsored By: EquipNet
When closing manufacturing operations, your project plan often calls for the partial or complete demolition of the plant’s structures and buildings. Learn the benefits of developing a pre-demolition strategy with EquipNet’s eBook. |
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Biosimilars: Global Impact of the Biologics Price Competition and Innovation Act of 2009
Sponsored By: Beckloff
On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which amends the Public Health Services Act (PHS Act) to create an abbreviated approval pathway for biological products that are shown to be highly similar (i.e., biosimilar) to or interchangeable with an FDA-licensed reference biological product. Biological products are generally derived from living material (e.g., human, animal, or microorganism), have complex structures and are usually not fully characterized. |
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How to Avoid (and Respond to) FDA 483s
Sponsored By: Vaisala
The following article shows excerpts from some common observations in Form 483 Letters. After the excerpts, we outline 10 best practices of a 483 response including links to further resources. Then we discuss different methods of monitoring, alarming and reporting critical parameters like temperature and humidity in FDA regulated environments and how to avoid deviations from cGMP in your regulated environments. |
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Improving Product Quality with Risk Assessment Tools
Author: Brenda Percy
Sponsored By: EtQ, Inc
With the product lifecycle moving so fast, many organizations may ask the question, "how can we effectively measure quality?" The answer is Risk Management. Learn the elements of Risk Management and how they help to identify, prevent, and mitigate risk throughout an organization. |
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Establishing Target Fill Counts
Author: Troy Fugate
Sponsored By: Compliance Insight Inc.
How do you determine acceptable tolerances for the in-process fill counts of tablets and capsules. |
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Ultrafast LCMS Analysis of Combination Cold Remedy
Sponsored By: Shimadzu
Now that ultrafast LC can provide analyses with peak widths in fractions of a second, it is necessary to have detectors that can keep pace with the sharp peaks generated by this technique. This application showcases the use of an ultrafast single-quad LCMS to support high-speed analysis. |
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Determination of Low Concentration Methanol in Alcohol by Affordable High Sensitivity Raman Instrument
Authors: Duyen Nguyen, Eric Wu
Sponsored By: Enwave Optronics
We present Raman spectroscopy as a quick and lower cost alternative to verifying the existence of low concentration methanol in alcohol. |
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Evaporative Light Scattering Detectors (ELSD) technology in R&D, QC, manufacturing, method's development or product support labs all over the world (Part 1)
Author: Tim Reyburn, C.E.O., Ticoscen Inc.
Sponsored By: Ticoscen Inc.
This white paper’s purpose is to provide general support to end users utilizing Evaporative Light Scattering Detectors (ELSD) in R&D, QC, manufacturing, method’s development or product support labs all over the world. Additionally, this paper puts into plain language what’s going on (in general) in the ELSD market as a whole in regards to the current ELSD platforms that are available. More specific insights, analysis and recommendations can be had by reaching out to Ticoscen. Ticoscen remains the only ELSD support services company specializing in ELSD repair, calibration, sales, training and application support for over 17 years now. |
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8 Steps to Validating/Mapping a Chamber
Sponsored By: Vaisala
Periodic mapping of conditions within environmental chambers such as refrigerators, freezers, RH chambers, or cGMP compliant warehouses is critical for compliance with FDA regulations. This application note recommends methods and key considerations to ensure that you fulfill the requirements for thermal validation projects. These are broad guidelines and for the sake of simplicity we refer to probes, sensors, data loggers interchangeably within this article. |
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THE CASE FOR UPGRADING EXISTING HPLC ASSAYS TO UPLC
Author: Eric Hill
Sponsored By: Impact Analytical
UPLC, ultra pressure liquid chromatography, is the successor technology to HPLC techniques and assays that have been widely used since the 1970s. UPLC has emerged from the laboratory over the past few years and moved to the bench top. It offers similar analytic capabilities as the more familiar HPLC, but operates at much higher pressures. This increased, or ultra, pressure provides the advantages of improved resolution, shorter run times, fewer consumables, and similar advances to separation science and those who depend on it to analyze and characterize vital compounds. |
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Humidity measurement in cleanrooms: The devil is in the details
Sponsored By: Vaisala
Systems used for measuring and monitoring RH play a small role in the overall picture of controlling cleanroom conditions, but problems inherent in humidity sensing can cause significant headaches for cleanroom operators. This article describes some observations and insights that are relevant to anyone in the cleanroom community who has struggled with humidity issues. |
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