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2:20 496. Process linkage approach for establishing critical quality attribute target ranges. S. Khoo, M. Mun,<br />

M.T. Schmidt<br />

2:40 497. Use of relevant process history for the determination of critical process parameters. B. Huffman, J.<br />

Cundy, K. Sunasara<br />

3:00 498. Using characterization data to support process validation: A Monte Carlo approach. C. Thompson,<br />

T. Linke, A. Hunter, G. Miro-Quesada, X. Wang<br />

3:20 Intermission.<br />

3:40 499. Defining process design space for a therapeutic monoclonal antibody: Clearance of phospholipase<br />

B-Like 2 (PLBL2), a CHO host-cell protein impurity, by hydrophobic interaction chromatography. A.<br />

Sanchez, J. Bill, S. Fisher<br />

4:00 500. Multivariate process monitoring towards enhanced continued process verification. C. Undey, S.<br />

Oruklu, B. Looze, C. Garvin<br />

4:20 501. Designing resin end of lifetime studies and their application in the three stages of process<br />

validation. A. Magill, E.S. Wilhelm, J. Weiss, D. Saini<br />

4:40 502. Improving the control strategy of legacy products using quality by design principles. D. Vu, A.<br />

Hagstrom, G. Miro-Quesada, G. Ferreira<br />

WEDNESDAY EVENING<br />

Westin San Diego<br />

Crystal II<br />

Biotechnology & Bioengineering Daniel IC Wang Award<br />

Section A<br />

T. M. Przybycien, P. M. Tessier, S. A. Tobler, Organizers, Presiding<br />

5:00 Biotechnology & Bioengineering Daniel IC Wang award presentation.<br />

THURSDAY MORNING<br />

Westin San Diego<br />

Crystal II<br />

Upstream Processes<br />

Engineering Natural Products Biosynthesis<br />

Section A

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