Nearly all drug substance and drug product CMOs have moved to a working system that uses dedicated project managers. There are still a few out there that appoint a given scientist as the manager, but more often than not, the scientists are asked to do their highest value function — the science itself. Read more.
Hospira One 2 One®: Contract development and manufacture of injectable products packaged in vials, PFS, cartridges, flexible containers, and ampoules.
Broad Range of Capabilities: Biologics, small molecules, potent drugs, vaccines, cytotoxics, controlled substances, beta-lactams, and lyophilization. Global manufacturing presence and extensive regulatory expertise.
Managing CMO Partnerships To Achieve Complex Production Objectives
By Ralph Lambalot, Ph.D., Abbott Laboratories
Building an effective, long-term CMO relationship poses significant challenges. In addition to an open, collaborative spirit, a strong partnership requires a successful technology transfer, a clear understanding by both partners of the key objectives at each project life cycle stage, and effective management of unexpected events. Read more.
The Role Of Pharmaceutical Packaging Partners In Times Of Growth
By Paul Dupont, Ropack
The expanding global pharmaceutical industry projects a 4% to 6% annual growth and forecasts that it will reach a value of $1T by 2014. The figures are impressive, yet they place significant pressure on pharmas to bring to market innovative drugs and novel drug delivery systems in order to be part of the growth. Read more.
Outsourcing Insights: Focusing On Innovation
By Kate Hammeke, research manager, Nice Insight
In 2011, innovation was a major topic among the various players in the drug development industry. Feedback from clients and sponsor-side industry personnel prompted a change in the outsourcing drivers included in the Nice Insight Pharmaceutical and Biotechnology Outsourcing survey, such that innovation replaced accessibility for the 2012 research cycle. Read more.
Ensuring A Streamlined Approach For Nasal Spray Product Development And Manufacturing
By Charles Shaw, Senior Manager of Research and Development at DPT Laboratories, Ltd.
The development of a successful nasal spray drug product is an intricate process that requires a good understanding of interactions between the formulation and the delivery device. This article aims to provide a comprehensive overview of the CMC guidance by the U.S. Food and Drug Administration and present a streamlined approach for development and manufacture of nasal spray products. Read more.
DSM's proprietary Rhobust® technology is a Second Generation Expanded Bed Adsorption (EBA) technology that provides an elegant solution for direct product capture in the first downstream process unit operation, by combining clarification and product capture into one single step.