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 eR&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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Identification of Anomalous Peaks in Sample Analysis
Author: Nick Toltl, PhD
Sponsored By: SGS Life Science Services
The sudden appearance of an unknown peak during an HPLC analysis of a pharmaceutical product can be a critical finding causing delays and requiring considerable resources to resolve. |
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Key Strategies to Consider Regarding MIST Guidelines
Author: Alan P. Breau, PhD
Sponsored By: MPI Research
Recent developments enable an early assessment to determine if human metabolism has a MIST guidelines issue. The information provides an opportunity to mitigate the issue without incurring the timeline and expense if discovered later in clinical development. |
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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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Technologies Drive Development and Manufacturing Innovation
Author: Junan Guo, senior director of pharmaceutical and quality services, AMRI
Sponsored By: AMRI
Integrated scientific solutions are assisting development and manufacturing customers move their candidates into clinical studies. Within Formulation Development and CTM Manufacturing, recent applications include Pro-Fill capsule filling, Xcelodose, and powder-in-bottle (PID) technologies. In Pre-Formulation and Material Sciences, applications include various screening methods, spray drying procedures, and X-Ray powder diffraction methods. |
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Case Studies: AccuPRO-ID® vs. VITEK® 2 Compact
Author: Christine Farrance, Ph.D.
Sponsored By: Accugenix, Inc.
Accugenix evaluated the accuracy of microbial identifications reported from the AccuPRO-ID® method to the results reported by the bioMérieux VITEK®2 Compact. The data clearly demonstrated that the AccuPRO-ID® service from Accugenix is significantly more accurate than the VITEK®2, leading to more confidence in the EM information and allowing for more effective microbial trending and tracking in a production facility. |
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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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Selecting the right CRO for the EDSP
Author: Ronald C. Biever
Sponsored By: Smithers Viscient, formerly Smithers Springborn
The US EPA’s Endocrine Disruptor Screening Program (EDSP) presents unique environmental testing challenges. This white paper examines a systematic way to identify the right CRO for your organization’s EDSP testing needs. |
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Security in the Supply Chain: A Buyer’s Guide
Author: Eric Kinaitis
Sponsored By: FedEx Custom Critical
Practical guidance on how to analyze the secure shipping capabilities of transport companies within the pharma supply chain. |
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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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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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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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Emerging Markets: Key Drivers for Success
Author: Neil Wilkinson
Sponsored By: NSF-DBA (USA) LLC
One of the leading questions asked of business leaders today is “what are your plans for the emerging markets?” A decade ago a Goldman Sachs analyst famously coined the term BRIC for the emerging markets of Brazil, Russia, India and China, predicting that these countries would surpass the economic output of the G6 countries within 40 years. A decade on this appears to be happening much more quickly than predicted. |
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Regulatory Review and Analysis of Independent Monitoring Systems
Sponsored By: Vaisala
This paper examines the importance of independent systems for monitoring and for control from a global regulatory perspective and gives guidelines to managing risk to product quality and mitigating the consequences of noncompliance with cGMP. |
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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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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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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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Quantitation Limit of Pharmaceuticals Determined by UV-Vis
Sponsored By: Shimadzu
Cleaning validation is essential in order to prevent 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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SAXS helps understanding Allergies
Authors: Dr. Heiner Santner, Dr. Erika Jensen-Jarolim, Dr. Alexander Bergmann
Sponsored By: Anton Paar USA, Inc.
In this study the crosslinking of an allergenic monomer was investigated with the SAXSess small-angle X-ray scattering system in order to understand the triggering step of an allergen. |
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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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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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Scale-up Strategies for Hot Melt Extrusion
Author: Mohammad Zafar
Sponsored By: PharmaForm
Hot melt extrusion is a continuous and scaleable process used for improving the bioavailability of poorly soluble molecules, making it attractive to the pharmaceutical industry. This whitepaper describes some of the factors to be considered during efficient extrusion scale up. |
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Controlled Release of APIs from EVA Copolymers
Authors: Dr. Ken Anderson, Dr. Andrew Loxley
Sponsored By: Celanese EVA Performance Polymers Inc.
Controlled release of cyclosporine or etonogestrel was demonstrated from ethylene vinyl acetate copolymers. Release of cyclosporine was faster from copolymer containing 28% vinyl acetate than from one containing 18% VA. |
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Blisterpack Leak Detection Accuracy
Author: Professor Dorian Dixon
Sponsored By: Sepha
A new whitepaper into the integrity of pharmaceutical packaging has established that existing methods for testing the seal integrity of blister packs are not as accurate as newer, technology based test equipment. The whitepaper was conducted by a leading packaging expert from the University of Ulster, Professor Dorian Dixon. In particular the study found that the laser based Blisterscan, manufactured in the UK by Sepha, was capable of detecting 15% more product defects than traditional blue dye test methods used by the majority of the pharmaceutical market. In the global pharmaceutical blister packaging market, valued at over $40 billion per annum, quality control is paramount and a 15% difference in the ability to detect if a product is sealed correctly or not is significant.
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Final Bulk Inspection of Solid-Dose Pharmaceuticals
Sponsored By: Symetix
In this white paper, we will explore the risks and consequences of using vulnerable inspection practices. We will also discuss the benefits and drawbacks of the several different kinds of bulk inspection systems in use in the pharmaceutical industry today. We will discuss the process improvements that can be achieved with continuous high-volume optical inspection systems. Lastly, we will suggest criteria to consider when selecting the right bulk inspection system for your application. |
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Seven Secrets to a Successful Auction
Authors: EquipNet
Sponsored By: EquipNet
Have you been elected to close your facility? Or do you have idle assets in your facility that need clearance? Selecting the right auction partner can be difficult. We created a Better Auctions Resource Center and an eBook, “Seven Secrets to a Successful Auction”, as tools to guide you through this process. |
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