Drug & Device Safety

Conferences & Courses
Extractables and Leachables Extractables and Leachables
January 21-22, 2016 | San Diego, CA
Cambridge Healthtech Institute' s Second Annual Extractables and Leachables conference focuses in biopharmaceutical drug development and manufacturing, containers, drug delivery devices/combination products (inhalers, pens, insulin pumps and implants), an

Managing Biomarker-Driven Clinical Trials Managing Biomarker-Driven Clinical Trials
February 23-24, 2016 | Miami, FL

Life Science Media Library
Strategies for Protein Purification and Overcoming Aggregation Strategies for Protein Purification and Overcoming Aggregation
January 20, 2013 |
Together with input from Sarah Bondos from Texas A&M University, Mario Lebendiker of the Wolfson Centre for Applied Structural Biology at The Hebrew University of Jerusalem provides an indepth overview of protein purification with a particular focus on aggregation problems. This course reviews: common causes of protein aggregation during expression and purification, methods to detect the presence of aggregates, the types and properties of chemicals that, when added to buffers, may improve protein solubility, and methods to screen these additives to rapidly optimize the solubility of your protein.
Navigating the Regulatory Hierarchy of Immunogenicity Navigating the Regulatory Hierarchy of Immunogenicity
October 9, 2012 |
Immunogenicity Summit 2012, led by Dr Amy Rosenberg, Director of the Division of Therapeutic Proteins at CDER and Paul Chamberlain from the NDA Advisory Board, a well recognized and experienced expert in presenting immunogenicity risk assessments to European and North American regulatory agencies. This product covers product quality aspects and clinical consequences and the immunogenicity risk assessment process, and provides real examples demonstrating the application of principles and an interactive case study.
Characterization and Analysis of Visible &Sub-Visible Particulates Characterization and Analysis of Visible &Sub-Visible Particulates
January 8, 2012 |
Sub-visible particles present in these biopharmaceutical products are a product quality attribute and a potential patient safety concerns yet to be fully explored. Early and consistent particle detection, quantitation and control throughout the product life cycle of these drugs from development to commercial lot release is critical in mitigating any concerns. This requires appropriate analytical methods which can be applied to biopharmaceuticals across a large variety of protein concentrations and modes of administration. This DVD will cover strategies to utilize complementary methods and techniques at different phases of product development.

Publications, Reports, & Whitepapers
Ocular Disorders: Rising Therapeutics, Technologies, and Devices
New to Insight Pharma Reports is: Ocular Disorders: Rising Therapeutics, Technologies, and Devices. This report covers several companies and their approach to targeting ocular diseases including wet and dry age-related macular degeneration (AMD) while also providing alternative therapeutic options for various ocular complications.
Vaccines: The End of Illness
This report analyzes recent trends in medicinal chemistry and evaluates their significance for advancing R&D productivity. We consider technological modalities and market dynamics, with an emphasis on outsourcing and user views on the implications of current practices.