Contributor Cindy H. Dubin talks with some of the leading experts in the industry about the importance of outsourcing analytical testing in the biologic/biosimilar space, the associated challenges, and how to ensure products get to market safely and quickly.
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.
Kevin P. Menard, PhD, focuses on the detection of residual solvents from processing and small levels of contaminates leached from containers.
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.
EXCLUSIVE ONLINE CONTENT
Fusion Antibodies Partners With Eurofins Discovery to Support Innovative Preclinical Drug Discovery Research
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Pace Life Sciences Acquires Drug Delivery Experts, Expanding Capacity & Injectable Drug Product Services
Pace Analytical Life Sciences, LLC, a subsidiary of Pace Analytical Services, LLC, a full-service contract development and manufacturing organization (CDMO), recently announced it has acquired Drug Delivery Experts, LLC (DDE)…..
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