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Using SPR for FDA Approved Batch Release and Assay Validation

The presentation covers the approach taken to develop and perform the SPR method used for Nucala product batch release identity and potency testing. The key requirements of the regulatory approved as say are explained through a case study of the Surface Plasmon Resonance method used to test the Nucala monoclonal anti body product at GSK’s Biopharma Central Testing laboratory.

The areas discussed in the presentation include:
- A brief summary of the monoclonal antibody products tested using SPR analysis.
- A breakdown of the regulatory approved SPR assay method used to generate sample and system suitability data, including a review of the assay acceptance criteria including the importance of using independent control samples. Example sensorgrams and sample loading schemes highlight the amount of data collected during analysis and the key details of the method format.
- The approach taken to ensure the Data Integrity of all SPR data generated by the GxP laboratory is maintained, including the supporting processes required for GxP testing and the procedures and the tools available to ensure that all data generated can only be used in accordance with the defined scope of the method, examples include discussions around user access levels, published procedures and validation of downstream processes used to handle raw data.
- The validation life cycle of an SPR assay from R&D - method development through to GxP approval for release testing. The scope includes a summary of some of the documentation expected for validating the SPR process for regulatory approved batch release. The influence of R&D - method development on the success of method validation in the live GxP environment. The impact of Data Integrity on validation and use of the method for release testing.
- Continuity of the SPR method’s validation status once approved, through equipment maintenance and procedure and software review.

Speaker:
Matthew Rutter
Quality Control Analyst, Glaxo SmithKline

Matthew Rutter is currently a Quality Control Analyst at Glaxo SmithKline’s Biopharmaceutical Central Testing Laboratory, with 3 years’ experience in his current role that includes routinely using and maintaining the SPR systems in the GxP environment for regulatory approved batch release and providing support for any validation activities regarding the SPR systems required. Areas of knowledge include GxP requirements and how SPR testing of antibody products is affected by the GxP environment and approaches to SPR analysis Data Integrity.