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Navigating the Biopharmaceutical Regulatory Pathway:
Replacing Undefined Raw Materials with Chemically-defined Substitutes
With market demands increasing, biopharmaceutical producers are constantly looking for ways to enhance product quality while reducing costs and risk. One way to meet these changing demands is to replace animal-derived supplements with chemically-defined substitutes. In this educational webcast, Dr. Michael Titus, Director of Quality Management and Regulatory Compliance with BD Biosciences, outlines the regulatory pathway involved in making such a switch. Click here to learn more.
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 Fill, Finish and Testing of Phase I/II Drug Products
Florida Biologix, a full service CMO for Phase I/II biologics, has significant experience with a variety of aseptic liquid fill projects. This presentation walks you through key considerations and decisions you will need to make when outsourcing a fill. It covers major activities involved in the process and the estimated timeframes you may face. The presentation provides information that anyone looking to outsource a clinical batch liquid fill needs to know to help ensure a successful outcome. Click here to learn more.
 Key Aspects of Managing Early Phase Development Programs for Long Term Success
From selection of a cell line to release of the first clinical batch, product and process developers make decisions that have timeline, financial, and regulatory consequences. As contract manufacturing becomes the norm rather than the exception in our industry, it is important that a Sponsor and CMO make the best use of each other's expertise for maximum benefit to product and patients. This presentation will highlight several CMC best practices for preclinical activities. Click here to learn more.
Blank Slate Biomanufacturing: Designing the Ideal Operation from a Blank Sheet of Paper
If you could start with a blank sheet of paper, what would your biomanufacturing operation look like? Robust, adaptable, cost-effective and efficient probably come to mind, but how do you get there? In this educational webcast, Parrish Galliher, Founder and CTO of Xcellerex, takes an in-depth look at the strategies involved in designing the ideal biomanufacturing facility from a blank slate. Click here to learn more.
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Disposable Downstream Processing for Clinical Manufacturing
BioProcess International, May 2011
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Maintaining Product Titer While Replacing Undefined Components in a CHO Culture System
BioProcess International, September 2009
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Practical Considerations for DoE Implementation in Quality By Design
BioProcess International, June 2010
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Raw Material Control Strategies for Bioprocesses
BioProcess International, April 2010
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Changes in Raw Material Sources from Suppliers
BioProcess International, April 2010
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Measuring Manufacturing Cost and Its Impact on Organizations
BioProcess International, June 2010
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