This Bioassays webinar will systematically outline the steps needed to successfully transfer validated biological assays between GMP/GLP labs and also acquire non-validated assays for GMP/GLP development.
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.
Participants in this seminar will attain a valuable checklist of critical information that will reduce delay and confusion during method transfer. The hands-on, common sense approach will provide a chronological pathway that can easily be adapted for any complex assay.
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.