Analytical Testing
RESIDUAL IMPURITIES – Developing & Validating an Efficient Method to Determine Residuals of Hormone Products by LC-MS After Cleaning of Equipment
Geoff Carr, PhD, describes the benefits of LC-MS and presents an effective method using this technology to determine the potential residual amount of eight active ingredients used in oral contraceptive tablets after cleaning equipment used in their manufacture.
MASS SPECTROMETRY – Access for All – A New Solution to the Age Old Challenge of a Multi-Vendor Open Access Laboratory
Hayley Crowe reviews AxION(R) eDoor(TM), a web-based, multi-vendor, open-access software platform that addresses all the complexities associated with analytical mass spectrometry analysis.
PREDICTIVE MODELING – Predicting Price Changes of Oncology Drugs in the US: Can Proportional Hazard Models Predict the Timing & Percentage of Changes?
Bruce Wang, PhD, MA, suggests that Cox Proportional Hazard Models can be used to predict price change percentages and timing of prescription drugs in the market, which is extremely valuable as it enables more informed insights through predictive modeling and analytics on the lifecycle of a drug.
LIPOSOME PREPARATION TECHNOLOGY – Freeze Fracture Electron Microscopic (ff EM) Examination & Analysis of Liposomes Produced by Covaris AFA Technology
Srikanth Kakumanu, PhD, and Rajeev A. Jain, PhD, explain how an alternative ultrasonic processing technology allows manufacturing of liposomes of predetermined sizes and offers an efficient, isothermal, and non-contact process.
AUTOLOGOUS CELL THERAPIES – Development of Autologous Cell Therapies: Keys to Clinical & Commercial Success
Ronnda L. Bartel, PhD, Tod Borton, and Brian S. Hampson review how Aastrom Biosciences has developed the innovative processes necessary to reduce risk throughout the manufacturing process. The company is now preparing for future commercialization for its investigational therapy derived from a patient’s own bone marrow stem cells.
IMPURITIES DETECTION – Impurities Detection in Pharmaceuticals
Kevin P. Menard, PhD, focuses on the detection of residual solvents from processing and small levels of contaminates leached from containers.
SPECIAL FEATURE – Analytical Instrumentation Gets Faster, Smaller, and Easier to Use
Contributor Cindy H. Dubin learns that one doesn’t have to be a rocket scientist to use analytical instrumentation. Three leading players in the market showcase their products, all aimed at making analysis easier and faster.
ANALYTICAL TESTING – Improvements in Characterization of Pharmaceuticals: Fast Scanning Rate DSC Methods
Kevin P. Menard, PhD, MBA, says fast scanning rate DSC represents a recent and underutilized technique for the characterization of pharmaceutical materials and highlights several of the more common applications.
ANALYTICAL TESTING – Analytical Tools & Techniques in Hot Melt Extrusion & Case Studies on Formulation Development & Process Scale-Up
Tony Listro, MS, MBA; Mike Borek, Michael Crowley, PhD, MBA; and Kathrin Nollenberger, PhD; review how a stepwise approach to characterizing formulation prototypes using microscopy, thermal analysis, spectroscopy, nonsink dissolution testing, and chromatography can be used to rapidly rank order formulations.
ANALYTICAL TESTING – Diffusion Kinetics & Permeation Concentration of Human SC Characterization by Terahertz Scanning Reflectometry
Anis Rahman, PhD; Scott Frenchek; Brian Kilfoyle; Leena Patterkine, PhD; Aunik Rahman; and Bozena Michniak- Kohn, PhD; use terahertz reflectometry and spectrometry to investigate the permeation kinetics and concentration profile of active ingredients into the stratum corneum.
EXCLUSIVE ONLINE CONTENT
Copley Launches New Semi-Automation Tool for Inhaled Product Testing
Copley Scientific, the global leader in inhaled product testing equipment, has launched the new Gentle Rocker 100i, a simple, cost-effective device that boosts the productivity and repeatability of….
FREEZE-DRYING MICROSCOPY – Unravelling the Complexities of Freeze-Drying Pharmaceuticals With Advanced Microscopy Techniques
Paul Matejtschuk, PhD, Prof Yvonne Perrie, and Robert Gurney, PhD, say FDM is being used to analyze the most challenging formulations that require sophisticated stabilization methods. By altering and adapting the three main freeze-drying stages to specific formulations, researchers are providing the tools needed for the pharma industry to improve its drug development processes and maintain drug stability when scaling up to production.
Proveris Expands Product Portfolio With New Kinaero Cx pMDI Collection System for Delivered Dose Uniformity & Aerodynamic Particle Size Distribution Testing
Proveris Scientific Corporation recently introduced the Kinaero Cx pMDI Collection System to automate the pMDI shaking, priming, dose sample collection, and fire-down for….
Malvern Panalytical Expands Pharmaceutical Drug Development Solutions Through Acquisition of Creoptix
Malvern Panalytical recently announced its acquisition of Creoptix AG, a specialist bioanalysis sensor company. The acquisition forms a critical part of Malvern Panalytical’s strategy to….
Inotiv, Inc. & Synexa Life Sciences Sign Letter of Intent to Establish Center of Excellence for Biotherapeutics & Biomarkers
Inotiv, Inc. and Synexa Life Sciences recently announced they intend to form a collaboration that will accelerate Inotiv’s development of biomarkers essential to the understanding of safety and efficacy of novel biotherapeutics, enhancing the….
WEBINARS
WEBINAR: BPOG 2020 & USP 665 – Extractables Testing of Single-Use Systems
This webinar will explore how to conduct effective extractables and leachables (E&L) testing on plastic process materials used during pharmaceutical and biopharmaceutical manufacturing…..
WHITE PAPERS
WHITE PAPER: Bring Quality OINDPs to Market Faster Than Ever Before | Proveris Scientific
Learn how the Proveris by Design(TM) approach is a proven tool for successfully developing nasal spray and inhalation drug products….
eBOOK: Antibody Production
Antibody production is a multi-step complex process and generating reproducible antibodies is highly critical for immunoassays-based research, immunodiagnostics, and immunotherapy. Antibodies’ reproducibility is driven by…