Name three problems you are trying to

Name three problems you are trying to prevent from occurring through formulation. (2 points) Q1 Answer: Q3: Your company wants to in-license a molecule from another company. You are part of the due diligence team and asked to evaluate, specifically, DP stability and formulation risks. The external company provides you with the data shown below. For each sub-question, can you name two additio experiments you would ask for? This in order to have a more complete data set to estimate its stabil The indication is for an autoimmune disease, where patient convenience is a must (meaning: self dosing) and a high dose is anticipated. (5 points) The company has provided %aggregation (by SEC) and charge profiles of the drug in formulations labelled “4”, “8”, “17” and “23”. The formulations are somewhat similar: phosphate, NaCl and sucros pH values. These data were collected over 1 month incubation at 40°C in the selected formulations. Protein concentration was 10 mg/mL, with protein from only one batch Viscosity data for unstressed drug (i.e. no incubation at 40°C) was provided in one formulation, going 50 mg/mL protein concentration. Q3 Answer: Q4: Describe one approach you might use to start your formulation work. What are its principles and how would you use them to design a formulation screen? Assume you have done pre-formulation studies using Research-made material and that you are now using Development (pilot) material. Suppose that in the pre-formulation studies you saw significant oxidation. How might you adjust you formulation work going forward? (5 points) Q4 Answer:

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