Single-Use BioProcess Components and Systems

2nd International Meeting

July 28-30, 2008
San Francisco, California

Topics:

• Single-Use Versus Reusable Components
• Extractables and Leachates
• System Integration and Validation
• Closed Systems and Aseptic Connections
• Vendor Certification and Audits
• Disposal Issues
• Testing Requirements and Standards
• Technology Transfer
• Contract Manufacturing Issues
• Storage and Qualification
• Product Comparability

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Tom Murphy, Ph.D. - ThermoFisher Scientific

Baxter Healthcare's Single-Use Contract Manufacturing Facility

As more biopharmaceutical products enter clinical trials and commercial production, it is becoming ever more challenging to guarantee the supply of critical raw materials and disposable process components. The sheer volume of some raw materials is testing the limits of many suppliers, while more applications move toward the use of prepared and pre-sterilized materials. Concurrently, quality control expectations are expanding to keep pace with the availability of increasingly powerful analytical techniques.

As a response to these trends, reliable vendors must be identified, evaluated, and then worked with closely to make sure they understand and are able to satisfy the volume, quality, documentation, and communication requirements of this rapidly growing industry.

Concurrently held with Raw Materials and Contract Services

Palace Hotel, 2 New Montgomery Street, San Francisco, CA 94105
Palace Hotel Website
Special Room Rate: $244 per night
Reservations Phone: 888.627.7196 (Be sure to mention you are attending WilBio's Single-Use BioProcess Components and Systems meeting.)

P.O. Box 1229, Virginia Beach, VA 23451
Phone: (757) 423-8823 • Fax: (757) 423-2065 • Email: info@wilbio.com