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Featured Whitepaper: Vaisala
How to Avoid (and Respond to) FDA 483s for Temperature, Humidity and other Controlled Environments
Sponsored By: Vaisala
This article shows excerpts from recent 483s issued for deviations in tracking and recording environmental parameters in various applications. The article outlines ten best practices of a 483 response, providing a checklist to make the 15-day response time limit more manageable. Included are multiple links to further reading, agency guidelines, and disputation information.
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WORKING WITH A CDMO TO IDENTIFY OPTIMAL PACKAGING OPTIONS
Sponsored By: DPT Laboratories
There are many factors to take into consideration when selecting or designing a packaging component. Working with a contract development and manufacturing organization early in the process helps eliminate packaging problems that may arise after the development stage. |
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Analysis of aggregates in nasal spray suspensions.
Author: Dr. Oksana Olkhovyk
Sponsored By: Gateway Analytical
This white paper reviews the importance of measuring particle size distribution and degree of aggregates in nasal spray formulations. Raman chemical imaging is presented as a greatly improved method of analyzing aggregates and agglomerates in nasal spray suspension formulations. Reviews the time and cost savings compared to current practice. |
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Robust Analytical Methods for Genotoxic Impurities
Authors: Lloyd Currin and Allen Kesselring, Ph.D.
Sponsored By: EAG Life Sciences
Genotoxic Impurities and Potential Genotoxic Impurities (GIs, PGIs) pose analytical method development and validation challenges for pharmaceutical development. This white paper illustrates overcoming specificity and low limits of detection difficulties for quantitative analysis of Genotoxic Impurities and Potential Genotoxic Impurities for methyl, ethyl and isopropyl camphor sulfonate esters in a drug substance. |
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Microbial Identification by MALDI-TOF Mass Spectrometry
Authors: Ann Russell, Ph.D. and Christine Farrance, Ph.D.
Sponsored By: Accugenix, Inc.
Choosing a microbial identification platform is complicated by the evolving number of technologies available for use. One of the newest identification systems utilizes MALDI-TOF mass spectrometry. We describe the technology behind this platform and discuss our experiences with the system’s performance when used for routine identification of environmental microorganisms. |
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Implementing Disposable Cleanroom Apparel into the Manufacturing Process
Authors: KIMBERLY-CLARK PROFESSIONAL* – (Damon Larkin)
Sponsored By: KIMBERLY-CLARK PROFESSIONAL*
This paper addresses the benefits of disposable cleanroom apparel versus reusable apparel. It explains how disposable cleanroom apparel can help play a role in helping pharmaceutical manufacturers reduce their waste stream while reducing the risk of contamination. |
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Melt Extrusion – Shaping Dosage Forms in the 21st Century
Authors: Charlie Martin; Feng Zhang, Ph.D.; James C. DiNunzio, Ph.D.
Sponsored By: Leistritz
Melt extrusion has been an established industrial manufacturing technology for more than 50 years. It is only in the last decade or so that it has emerged as a viable platform for pharmaceutical development. Today, applications of melt extrusion range from controlled release systems to oral bioavailability enhancement and show potential for small molecules and therapeutic peptides. |
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CRITICAL CLEANING APPLICATIONS IN PHARMACEUTICAL MANUFACTURING
Authors: Jeff Phillips, Sr. Manager, Science and Marketing
Sponsored By: ALCONOX
Discussion on the benefits of employing aqueous cleaning in pharmaceutical manufacturing. The proper use of aqueous cleaning helps manufacturers minimize surface residue and makes cleaning validation easier. |
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Technical Choices for WFI Production
Authors: Geoff Sheffrin P. Eng.
Sponsored By: OBK Water – Division of OBK Technology Ltd.
WFI from a ‘still or from two pass RO?’ Is the ‘still unquestionably safer than the two pass RO?’ The question continues to cause discussion between the jurisdictions. Neither is foolproof. |
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Life Sciences Guidebook on Best Practice Compliance Solutions
Author: Tim Lozier
Sponsored By: EtQ, Inc
This paper provides you with a basic overview for selecting, implementing and using FDA Compliance and Quality Management solutions. Learn the importance of QMS, best practices for FDA Compliance and Quality systems, and tips and tricks for finding the solution best suited for your company. |
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505(b)(2): Fast and Cost-Effective Drug Approval
Sponsored By: Camargo Pharmaceutical Services
Looking to identify a new product for development? Ready to roll over a compound into a new application? The 505(b)(2) pathway is a fast and cost-effective route for drug approval. With global reach across 26 countries, Camargo Pharmaceutical Services executes 505(b)(2) programs for both small and large molecules. |
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FT-IR Analysis of Dimethicone Based on USP-Specified Method
Sponsored By: Shimadzu
When analyzing viscous solutions by FTIR spectroscopy, the ATR method is particularly effective because the close contact between the sample and prism is easily achieved. This application illustrates an example with the analysis of dimethicone, with good repeatability clearly obtained. |
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XRPD Pattern Recognition and Clustering Analysis
Author: Simon Bates, Ph.D.
Sponsored By: Triclinic Labs, Inc.
When performing a solid state screen - whether it be for new crystalline forms (polymorphs, hydrates, solvates, pharmaceutical salts, cocrystals or co-crystals) or disordered forms - there is usually a plethora of data collected on very small non-ideal samples. The use of knowledge in the form of indexed unit cells can help make form identification more robust for lower-quality XRPD screening spectra. |
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Simultaneous Quantitation of Multiple Amyloid Beta Peptides in Cerebrospinal Fluid Using SPE with UPLC/MS/MS
Author: Erin E. Chambers (Waters Corporation), Mary E. Lame (Pfizer, Neuroscience Research Unit), and Diane M. Diehl (Waters Corporation)
Sponsored By: Waters Corporation
In this work, a fast and flexible platform that combines state-of-the-art sample extraction products with UPLC/tandem quadrupole mass specrometry for the quantification of multiple amyloid beta (aß) peptides from human or monkey CSF for use in a biomarker or preclinical discovery setting. The featured mass spectrometry platform is the Waters Xevo TQ-S mass spectrometry system, which facilitated both a 4X reduction in required sample size and a 4-5X increase in assay sensitivity compared to other LC/MS/MS systems. |
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What You Should Know About Lean Six Sigma Initiatives
Authors: Jim Webber
Sponsored By: Compliance Insight Inc.
Investment in improvement can take many forms, e.g. capital improvements, equipment upgrades, product redesign, etc. All work is achieved through processes, so if those processes are ineffective and/or inefficient, then less than perfect outputs/cost are the result – and not just once – but over and over again! Resources are scarce, and always will be. Therefore utilization of the resources allocated to process improvement must be done with careful planning and within a well thought-out framework – if you want your organization to have a culture of superior performance. This paper lays out the framework – the foundation for an effective continuous improvement initiative. |
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Developing Palatable Drug Products – Top 10 Myths of Taste Masking
Authors: Jeff Worthington, David Tisi
Sponsored By: Senopsys LLC
Developing palatable drug products can be a challenge for many APIs with aversive taste attributes. This paper provides an overview of the science and formulation principles of taste masking and dispels the ten most common myths. |
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Major Freeze Drying project for vials
Author: Felix Henning
Sponsored By: Optima Group Pharma GmbH.
The freeze drying systems are configured in a “C-type” design to ensure a particularly compact and spacesaving arrangement. The chamber and condenser are located one on top of the other, but are combined in a common housing. |
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Whitepaper Title: Stick or Carrot?
Author: Neil Wilkinson Senior Partner NSF-DBA LLC
Sponsored By: NSF-DBA (USA) LLC
What will eventually wake up the US Pharma industry to the importance of Quality; the stick, or the carrot? Roll the clock back to the early 2000s – groundbreaking discussions between FDA and Industry that led to the ‘cGMP for the 21st Century’ philosophy – science and risk-based approaches to quality.
Scroll forward to 2008 – the issue of ICH Q10 'Pharmaceutical Quality System' – a model QMS that should drive improvement in products and processes. What about 2012....? Read more now. |
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Drug Layering onto Fine Particles
Author: Shinichiro Tsue
Sponsored By: Nisso America
We evaluate special low viscosity hydroxypropyl cellulose (HPC-SSL) as a novel binder for drug-layering onto fine particles by spouted-bed spraying process. |
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