Pharmaceutical Technology Whitepaper Alert:
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Featured Whitepaper: Surety LLC
Will Your Electronic Research Records and Files Stand Up in Court?
Protecting Your Scientific Intellectual Property for the Long Term
Sponsored By: Surety, LLC
As more pharmaceutical, bio-sciences and R&D-centric firms move to electronic lab environments, your digital scientific research, formulas and clinical findings are your Intellectual Property. Protecting the integrity and legally defending the authenticity and ownership of such electronic data is critical to your organization’s long-term success. But if you are overlooking this protection in your lab management workflows, you risk losing patent ownership, revenue and consequently your business, if you can't prove authenticity and time of creation in a court of law. This new whitepaper from IP Protection Leader, Surety, explores these concepts and requirements, and discusses how you can implement simple, cost-effective controls to achieve legally enforceable scientific IP for the life of the research record.
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The Aclar advantage for blister packaging
Authors: David Barker, Global Marketing Development Manager, Honeywell Healthcare & Packaging, Charles Rowlands and Amy Morgan, Founding Partners, RM Consulting
Sponsored By: Honeywell International Inc.
This paper examines the strategic implications of packaging choice in the generics industry. It looks at how companies are leveraging ultra high barrier thermoform solutions like Aclar ® to create new value propositions. |
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Ropack Stickpack Packaging
Author: Paul Dupont
Sponsored By: Ropack
This whitepaper considers the benefits of stickpack to consumers and to pharmaceutical, nutraceutical and consumer health-care firms. It notes unique production requirements and process features significant to product integrity. |
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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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Cold Chain Transportation |
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Ultrafast LC Analysis of Mexiletine, Pilsicainide, and Zonisamide in Serum
Sponsored By: Shimadzu
There is demand for faster HPLC analysis to improve the productivity of drug pharmacokinetic studies and clinical testing, particularly when handling many samples. This application note introduces various analyses using high-speed LC. |
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Structure Analysis For Allergy Research
Authors: Heimo Schnablegger, Heiner Santner
Sponsored By: Anton Paar USA, Inc.
Allergic reactions start with the crosslinking of Immunoglobuline E antibodies to specific antigens (allergen). The SAXSess small-angle X-ray scattering system provides insight into the triggering mechanism on the example of Bet v 1, the major birch pollen allergen. |
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Next Generation NIR for PAT
Author: Claude V. Robotham
Sponsored By: Thermo Scientific
Real time process monitoring during pharmaceutical manufacturing is critical to ensure consistent product quality and to maintain an efficient, cost-effective manufacturing process. |
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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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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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Provide Precise, Seamless Liquid Filling
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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Cold Water Granulation Using Pregelatinized Starch
Sponsored By: Grain Processing Corporation
Quality granulations can be made using only cold water as the binding solution and fully pregelatinized corn starch as the binder. Using Spress® B825 Pregelatinized Corn Starch NF in the manner described eliminates solution preparation and simplifies the granulation process which accelerates production resulting in cost reduction. |
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Using Photostability Chambers to Meet Requirements of ICH, Q1B
Sponsored By: CARON
For companies performing photostability testing in accordance with ICH Guidelines, Q1B, Caron’s 6540 series chambers overcome the challenges of lamp selection, light control and other chamber design issues. By integrating technical requirements with practical solutions, Caron’s Photostability Chambers enhance the testing process to ensure product quality and regulatory compliance. |
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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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Optimize your ELSD for best performance
Author: Timothy P. Reyburn
Sponsored By: Ticoscen, Inc.
In this whitepaper from the Evaporative Light Scattering Detector servicing experts,Ticoscen Inc. provides some basic optimization tips. |
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Evaluating Library Databases for Microbial Identification
Author: Mark Calmann
Sponsored By: Accugenix, Inc.
A thorough evaluation process for microbial identification systems should consist of both a technical and financial review, regardless if you are performing internal testing and outsourcing. All evaluations should include a detailed list of specifications to meet your laboratory’s objectives. |
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Targeting PK and Patient Needs with Versatile, Timed-Based Oral Drug Delivery
Authors: Michael A. Gosselin, Ph.D. and Vincent Parrino, M.Sc., M.B.A
Sponsored By: Eurand Pharmaceutical Technologies
Through the development of more favorable pharmacokinetic profiles to meet specific patient needs, industry has successfully leveraged various drug delivery technologies for oral modified-release products. Multiple challenges may arise during the development of these dosage forms, including poor drug stability, low aqueous or pH-dependent solubility, narrow therapeutic windows, and food effects. This paper focuses on the solutions provided by optimizing timed-based pulsatile and sustained delivery profiles using multi-layered particulate dosage forms, for both acidic and alkaline drugs. |
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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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The Regulatory Paradox of Laboratory Developed Tests
Sponsored By: Beckloff
FDA’s statutory jurisdiction, hence the regulatory obligations governing the design, characterization, production, and commercialization of laboratory developed tests (LDT), is defined in part by two central elements—(a) the degree of risk associated with the use of the device, and (b) the device’s intended use. |
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