Question: Respond to this post from a classmate: A comprehensive framework is critical in the analysis of therapeutic antibody models. A subset of upstream analytical techniques

Respond to this post from a classmate: A comprehensive framework is critical in the analysis of therapeutic antibody models. A subset of upstream analytical techniques would be utilized based on the complexity of the process, regulatory requirements, infrastructure, cost-benefit, and the stage of production. Upstream techniques include dissolved CO2 monitoring as a requirement (maintains optimal gas exchange for cell growth), fluorescence and optical monitoring (offers in-depth information on cellular metabolism), NIR spectroscopy (monitors metabolites and nutrients), In-situ microscopy (to assess growth) , and amino acid analysis (helps to maintain nutrient levels and increase yield). The process would also be subject to mid and downstream analytics including antibody titer measurement (to actively monitor production), glycosylation profiling, and electrochemical immunoassay. All of the requirements for the analysis of production are dictated by departments such as the FDA, ICH, USP and more acting regulatory bodies. Not all of these methods would be utilized in a single production process, that would be far too complex and expensive. Utilizing the correct tools for the specific process would be practical and more efficient

Step by Step Solution

There are 3 Steps involved in it

1 Expert Approved Answer
Step: 1 Unlock blur-text-image
Question Has Been Solved by an Expert!

Get step-by-step solutions from verified subject matter experts

Step: 2 Unlock
Step: 3 Unlock

Students Have Also Explored These Related Accounting Questions!