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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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Identifying the Product
Sponsored By: Camargo
With a generic cliff approaching, the 505(b)(2) development process can make changes to reference products for greater profit potential and lower risk. Camargo offers a clear process to identify products that have documented market differentiation. With global reach across 26 countries, Camargo executes 505(b)(2) programs for both small and large molecules. Download more….click here. |
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Elemental Impurities: Navigating the Proposed Regulations of USP <232> and <233>
Author: David Kesselring, Ph.D.
Sponsored By: EAG Life Sciences
The implementation of the proposed chapters USP chapters on elemental impurities, <232> and <233> is best suited to the use of closed vessel digestion and analysis by an ICP analytical technique. This paper addresses the challenges involved, as well as appropriate methods, procedures, and limits associated with this analysis. |
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Microbial Identification by MALDI-TOF Mass Spectrometry
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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Quantification of Exenatide using Xevo TQD
Authors: Joanne Mather, Erin Chambers, Robert Plumb, Debadeep Bhattacharya
Sponsored By: Waters Corporation (Bioanalysis)
This application note showcases the capabilities of the Waters Xevo TQD triple quadrupole MS along with the ACQUITY UPLC H-Class System to achieve a sensitive LC/MS/MS method for the detection and quantification of exenatide in plasma. |
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Examining the Role of TOC Analyzers in the Pharmaceutical Laboratory
Sponsored By: Shimadzu
Within the pharmaceutical industry, TOC analyzers serve vital roles in the manufacturing process, from inspections of the water used in drug manufacture (ultrapure water) to evaluation of cleaning effectiveness (cleaning validation). This paper examines their use and presents some application data. |
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Extractables and Leachables Risk Assessment Case Study
Author: Andreas Zumdick
Sponsored By: SGS Life Science Services
An extractables and leachables case study describes how a comprehensive risk assessment was performed across the entire production process of a European manufacturing plant for 40 finished products, resulting in a global testing plan. |
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Metabolic Investigation of Urine and Plasma Profiles Obtained from Alcohol-Dosed Mice Using Accurate Mass LC-MS-MS
Authors: Craig Dorschel, Robert Plumb, Ian Wilson, Paul Rainville and John P. Shockcor
Sponsored By: Waters Corporation (UNIFI MetID)
This poster demonstrates the evaluation of the global changes in metabolic profile for plasma and urine following chronic alcohol exposure using LC/MS/MS metabolomics analysis with the Waters Metabolite Identification Application Solution. In this study a rodent “intragastric feeding model” was used together with accurate mass LC/MS/MS analysis to determine changes in the global metabolic profiles in both plasma and urine. The resulting raw data obtained was analyzed by multivariate statistical analysis (using principal components analysis). |
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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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Implementing Disposable Cleanroom Apparel into the Manufacturing Process
Sponsored By: KIMBERLY-CLARK PROFESSIONAL* – (Damon Larkin)
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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CRITICAL CLEANING APPLICATIONS IN PHARMACEUTICAL MANUFACTURING
Author: 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
Author: 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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Blisterpack Integrity Testing Using Sepha VisionScan
Author: Dr. Dorian Dixon
Sponsored By: Sepha
An overview of Sepha's VisionScan technology in detecting integrity breaches in a range of pharmaceutical blister package types using non-destructive methods compared to traditional blue-dye testing. |
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DEA Approved Drug & Pharmaceutical Storage Cages
Author: WireCrafters
Sponsored By: WireCrafters
When Oak Ridge Pharmacy needed a DEA pharmaceutical storage cage, they knew to call their local material handling distributor, and they knew to call WireCrafters. WireCrafters is the leading manufacture of woven and welded wire partitions in the United States. WireCrafters DEA Drug Storage Cage application is one of the original reasons that WireCrafters has became a leader in the wire partition industry. |
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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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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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The Power of Virtual Quality: Optimizing quality in a regulated environment
Author: Troy Fugate
Sponsored By: Compliance Insight Inc.
Sponsor or innovator companies must maintain full responsibility over their processes and products, even when outsourcing or working with third parties. Some of these companies find it increasingly difficult to manage the number of audits or investigations that may be required at the global level on their own. Pharmaceutical Technology spoke with Troy Fugate, Vice President of Compliance Insight to gain some insight into how virtual quality resources can help companies in the current regulatory environment. |
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Fast Structure Analysis of Excipients by SWAXS
Author: Aden Hodzic
Sponsored By: Anton Paar USA, Inc.
Small- and wide-angle X-ray scattering (SWAXS) is a powerful tool to characterize samples containing nano-sized lamellar structures. These structures play an important role in pharmaceutical applications. SAXS determines the self-assembled structures, e.g., lamella repeat distance. WAXS determines the crystallinity at the atomic level as a fingerprint of these materials. |
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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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