By Anurag S Rathore; G K Sofer

content material: instructions to strategy Validation, G. Sofer functions of Failure Modes and results research to Biotechnology production strategies, R.J. Seely and J. Haury procedure Characterization, J.E. Seely Scale-Down versions for Purification approaches: methods and functions, R. Godavarti, J. Petrone, J. Robinson, R. Wright, and B.D. Kelley Adventitious brokers: issues and trying out for Biopharmaceuticals, R. Nims, E. Presente, G. Sofer, C. Phillips, and A. Chang lifestyles Span experiences for Chromatography and Filtration Media, A.S. Rathore and G. Sofer Validation of a Flitration Strap, J. Campbell Analytical try out equipment for Well-Characterized organic and Biotechnological items, N. Ritter and J. McEntire Facility layout Issues-A Regulatory viewpoint, N. Roscioli and S. Vargo Validation of automatic structures, M.J. Cahilly approach Optimization and Characterization experiences for Purification of an E. coli-Expressed Protein Product, A.S. Rathore Validation of the ZEVALINO Purification procedure - A Case examine, L. Conley, J. McPherson, and J. Thommes procedure Validation of a Multivalent Bacterial Vaccine: a unique Matrix method, N.S. Pujar, M.G. Gayton, W.K. Herber, C. Abeygunawardana, M.L. Dekleva, P.K. Yegneswaran, and A.L. Lee Viral Clearance Validation: A Case learn, M. Rubino, M. Bailey, J. Baker, J.A. Boose, L. Metzka, V. Moore, M. Quertinmont, and W. Wiler in regards to the editors... ANURAG S. RATHORE is a Scientist in approach improvement, Amgen Inc., Thousand Oaks, California. His staff is chargeable for the aid of technique improvement, method characterization, scale-up, creation, and approach validation of overdue level items. ahead of becoming a member of Amgen Inc., he held an analogous place at Pharmacia company. Dr. Rathore has authored greater than 50 courses and displays and is sequence editor of the Biotechnology and Bioprocessing sequence for Marcel Dekker. he's the editor of numerous contemporary books together with Scale-up

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Example text

15 FMEA Worksheet .......................................................... 16 Evaluation Criteria: Severity, Occurrence, and Detection................................................................. 1 Severity ............................................................... 2 Occurrence........................................................... 3 Detectability........................................................ 6 Example of FMEA Applied to Process Transfer ......... 7 Next Steps......................................................................

The FMEA has resulted in (1) documentation that every element of the process (for characterization or for transfer) has been evaluated by a team, and (2) a prioritization of parameters or issues that now need to be addressed. Based on the RPNs, as visualized in Pareto fashion, the team should agree on a cutoff value for studying the “high” RPNs first, and perhaps some or all of the others as time and resources permit. As previously mentioned, this cutoff can be made prospectively (although for a biological process, this may be difficult and is not necessary), or it can be made retrospectively based on the results.

M. J. M. I. L. I. L. 3 Unit Operation Temperature mapping studies Current Controls 2 0 20 0 Detection RPN 24 Seely and Haury Fermentor R-0180 seal/ pressure Innoc. vial handling B. W. Contamination B. W. Leakage Handling of vials B. D. from freezer to plant will be equivalent to B-7 Assembly and maintenance Utility failure Inadeq. ster. cycle 10 10 10 Utility failure 4 Design Assembly and maintenance 4 10 Design 4 2 2 5 5 100 40 0 Applications of Failure Modes and Effects Analysis 25 26 Seely and Haury streamlined version of those provided in the references for the more “classical” FMEA applications.

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