Raphael Fish | Engineer II, Downstream Process Engineering
Genentech

Raphael Fish, Engineer II, Downstream Process Engineering, Genentech

  • Raphael is Process Engineer in the Manufacturing Sciences and Technology (MSAT) group at Genentech, where his work focuses primarily on tech transfer and on evaluation/implementation of manufacturing technologies, particularly in areas related to process intensification and process analytical technology. Prior, Raphael held multiple roles in the large molecule process development organization at Genentech, including roles in purification development, cell culture development, protein analytical chemistry, and formulation development.

Appearances:



Festival of Biologics Day 1 @ 14:00

Fly me to the MARS: Multi-attribute Raman Spectroscopy for Protein Therapeutics

Rapid release of biopharmaceutical products enables a more efficient drug manufacturing process. Multi-attribute methods that target several product quality attributes (PQAs) at one time are an essential pillar of the rapid-release strategy. The novel, high-throughput, and nondestructive multi-attribute Raman spectroscopy (MARS) method combines Raman spectroscopy, design of experiments, and multivariate data analysis (MVDA). MARS allows the measurement of multiple PQAs for formulated protein therapeutics without sample preparation from a single spectroscopic scan. Variable importance in projection analysis is used to associate the chemical and spectral basis of targeted PQAs, which assists in model interpretation and selection. This study shows the feasibility of MARS for the measurement of both protein purity-related and formulation-related PQAs; measurements of protein concentration, osmolality, and some formulation additives were achieved by a generic multiproduct model for various protein products containing the same formulation components. MARS demonstrates the potential to be a powerful methodology to improve the efficiency of biopharmaceutical development and manufacturing, as it features fast turnaround time, good robustness, less human intervention, and potential for automation.

last published: 31/Jan/23 09:55 GMT
last published: 31/Jan/23 09:55 GMT

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