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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Considerations in Ophthalmic Formulation Development for Various Ocular Diseases
Author: Dr. Yunik Chang
Sponsored By: Dow Pharmaceutical Sciences, Inc.
Discussion about ophthalmic formulation technology and the challenges for scientists and formulators who are interested in developing eye-care products. |
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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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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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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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Accelerating Generic Approvals: Keys to Being First
Author: Marilyn Seiger
Sponsored By: BASi
Saving time and costs are extremely important in developing a generic product. How to choose a qualified CRO to help you overcome common development challenges. |
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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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Building the Business Case for a Rapid Detection System
Sponsored By: Rapid Micro Biosystems
Managing quality in the pharmaceutical manufacturing process is paramount. Automated rapid microbial testing provides tangible benefits such as reduced testing time, improved resource availability and minimized risk. Learn tips to build a business case. |
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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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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 APIs/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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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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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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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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Provide Precise, Seamless Liquid Filling
Author: Gregg E. Johnson, Thermo Fisher Scientific, Fluid Handling, Barrington, IL, USA.
Sponsored By: Thermo Fluid Handling
Sterile liquid flow is paramount in pharmaceutical and bioprocessing applications, which is why Thermo Scientific Masterflex peristaltic pumps are highly-suited for these demanding processes. |
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UHPLC Performance Evaluation of Carryover Using Reserpine in Human Plasma
Sponsored By: Shimadzu
High-speed, high-resolution analysis technology is now being used in LC/MS/MS analysis of drugs in plasma. However, autosampler carryover can have adverse effects on high-sensitivity LC/MS/MS analysis. This paper introduces a carryover evaluation using reserpine in human plasma. |
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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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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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Work Faster and Smarter with Next-Generation Handheld Raman for Raw Material Identification
Author: Alyssa Knightly
Sponsored By: Thermo Scientific
The TruScan RM analyzer is our lightest, fastest and most portable analyzer for raw material inspection. It is highly specific and performs rapid identification of a broad range of compounds at the point of need to decrease sampling costs and increase inventory turns. The analyzer offers enhanced 21 CFR part 11 compliance features and is consistent with USP and EP regulations. |
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Scale-up Strategies for Hot Melt Extrusion
Author: Mohammad Zafar
Sponsored By: PharmaForm
Hot melt extrusion is a continuous and scalable 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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New HPC grade for DC
Author: Shinichiro Tsue
Sponsored By: Nisso America
We prepared new Super Fine Powder, Special Low Viscosity grade Hydroxypropyl Cellulose with the purpose of developing a high performance dry binder with high compression formability at low use levels. |
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Seven Secrets to a Successful Auction
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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