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. Dr. Titus will discuss:

• A background on the uses of supplements in the cell culture production process;
• Change control & risk management;
• And the regulatory path of making the switch to chemically-defined supplements.

Join Dr. Titus as he demonstrates how chemically-defined supplements can boost performance, reduce risk and increase consistency in commercially marketed biopharmaceutical products.

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. You’ll learn how to optimize your operation to:

• Increase Speed
• Enhance Flexibility
• Decrease Risk
• Improve Economics

View this webcast to discover the steps for maximizing your biomanufacturing process.

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. In this presentation, Dr. George Koch, Chief Scientific Officer for Contract Manufacturing and Director of Project Management with Fujifilm Diosynth Biotechnologies, provides insight into:

• Selecting a CMO
• Process and Method Development
• The First Tox Lots
• The First Clinical Lots

View this on-demand educational webcast to learn more about manufacturing best practices for preclinical activities.

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. This webcast discusses the major considerations involved in the process, such as:

• Timeline
• Component, Volume & Testing
• Documentation
• Execution
• Shipping, Handling and Storage

The presentation provides information that anyone looking to outsource a clinical batch liquid fill needs to know to help ensure a successful outcome.

Global Material Harmonization for Increased Effectiveness and Reduced Risk

As geographic distances continue to metaphorically shrink, there is an increased focus on improving operational effectiveness. But, in order to increase effectiveness, it is important to understand and mitigate risk. In this on-demand webcast, Ben Locwin of Lonza Biologics demonstrates how material harmonization can help reduce risk and increase effectiveness by allowing:

• Use of one material specification
• Shared testing
• Shared raw material qualifications
• And more.

View this webcast to learn more about how synchronization of raw material testing can not only improve effectiveness, but reduce risk and lower costs as well.