Monday, November 1, 2010 Daily Archives

Technology Transfer Challenges for In-Licensed Biopharmaceuticals

    During the lifecycle of a biopharmaceutical, occasions arise in which the facility and support organization responsible for ensuring that it is manufactured according to schedule, demand, and quality specifications must change, either in whole or in part. The reasons for this vary: some related to scale, some related to clinical development phase, some related to internal manufacturing capacity and program ownership. The industry has adopted the term technology transfer to describe these events. Many such situations have been…

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.

Integrity Systems: A Comprehensive Toolkit for Single-Use Solutions

Single-use solutions are in growing demand within the biopharmaceutical manufacturing industry. With a complete line of solutions — from mixing systems to ultra-clean packaging — ATMI LifeSciences is a leader in these technologies. In this educational webcast, Jared Hisle, Global Product Manager at ATMI LifeSciences, explores the full line of Integrity™ Systems single-use technologies, including:

• NewForm™ Sterilizable Packaging
• Integrity™ Liquid and Powder Vessels
• Integrity™ Mixers
• Integrity™ Bioreactors

ATMI maintains the world’s largest installed base of single-use mixing systems and offers the world’s only single-use platform including film extrusion. Join Hisle as he demonstrates the advantages of ATMI’s single-use solutions.

Quality by Design (QbD): Defining Hydrolysates & Designing Quality

Complex. Undefined. Variability. These are all typical attributes that are used to describe protein hydrolysates because they are exactly that — complex, undefined and their performance may vary on a lot-to-lot basis. But despite all of the uncertainties, using hydrolysates as media supplements can stimulate cell growth and improve protein production — and ultimately lower the cost of goods tremendously. That is why the scientists at FrieslandCampina Domo have started the project “Defining Hydrolysates and Designing Quality.”

In this educational webcast, Dr. Jan Boots of FrieslandCampina Domo answers the questions — Can hydrolysates be defined? And can consistent quality be designed into them? Join Dr. Boots as he explores the complexity of hydrolysates and how Domo is working to define them.