Resin Recycling Studies

This document outlines a comprehensive resin recycling study, covering key protocols and procedures essential for the process. It includes the establishment and transfer of Analytical Method Transfer Protocols, development and implementation of Scale Down Model Protocols, and the execution of Resin Cycling Protocols, involving sample analysis and data collection.

Formal protocols are reviewed and signed off by the client before any experimental work begins, and final reports are compiled after client approval, with flexibility for clients to arrange data in their preferred format. All data undergoes 100% verification by QA personnel, and raw data is made available for client review post-study. Materials are pre-approved by the client before procurement, and any residual materials or used resin are shipped back upon completion.

The project is structured into several phases, including Analytical Method Transfer (12 weeks), Baseline Runs (3 weeks), and Chromatography Resin Studies — Protein A Chromatography (240 runs over 18-20 weeks) and Ion Exchange Chromatography (120 runs over 11-12 weeks). Execution phases include material list preparation, protocol finalization, baseline and cycling runs, and the compilation of the final report for client review.