BIOTECH 2012 - Accelerating Bioassay Transfer in a GMP Environment

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Category Assay Transfer; Transfer of Bioassays; GMP/GLP labs; validated assays; non-validated assays; biological assays transfer

Deadline: February 23, 2012 | Date: February 23, 2012

Venue/Country: Palo Alto, U.S.A

Updated: 2011-12-08 20:06:32 (GMT+9)

Call For Papers - CFP

Why Should You Attend:

50% of the drugs presently in discovery are biopharmaceuticals - these numbers lead to an "outsource or perish" philosophy for GMP/GLP development, validation and sample analysis. Unlike synthetic drugs requiring only straightforward analytical testing biopharmaceuticals require more elaborate assays to attain regulatory compliance. The industry has a significant underestimation of the discipline; skills and planning required to successfully transferring these assays. Naiveté in this area causes loss of precious time and money during development.

Areas Covered in the seminar:

This webinar systematically outlines the steps needed to successfully transfer validated biological assays between GMP/GLP labs and also acquire non-validated assays for GMP/GLP development. Topics to be addressed are:

- Setting a realistic timeline for your assay transfer.

- Issues that need to be addressed in preliminary discussions between the labs.

- Proper method writing.

- Parameters to be evaluated during transfer - the transfer protocol.

- Transfer report.