RESUMO
It is critical that manufacturers understand the impact of resin variability on process performance and consistency. Choosing an appropriate resin lot often requires running manufacturing load material on a scale-down processing step and showing that the product recovery and purity is within manufacturing experience. In the present study, the LR (lysozyme retention value), on the vendor Certificate of Analysis, was predictive of the performance of an HIC (hydrophobic interaction chromatography) resin in a complex manufacturing step. This processing step is used to reduce host cell PIs (protein impurities) while maintaining a desired glycoform profile of recombinant TSH (thyroid-stimulating hormone). A correlation was found between a first-moment analysis of the HIC elution peaks and resin LR. Approximately 91% of the observed variation was accounted for by resin LR, and LRs of 55 and 50 were significantly different. The acceptable LR range, to maximize glycoform profile reproducibility and minimize recovery fluctuations, was dependent on the product collection method. Only resins with a narrow LR range within 1-2 units would be acceptable in a procedure in which set volume fractions are collected. Resins with an LR from 49 to 55 were appropriate when TSH collection was based on A280 ranges and this approach had the added benefit of collecting a single product pool.
