Suggest an alternate formulation with no crystallizing


Assignment task:

Hypothetical example - You have received a new molecule where someone tried to develop a liquid formulation but was not able to provide adequate stability.  Their best formulation contained 20 mg/mL protein (5%) in 20 mM histidine (0.3%), 85 mM NaCl (0.5%), 3% sorbitol, pH 6.0.

1. Suggest an alternate formulation with an excipient that will crystallize and calculate the Tg'.  Ensure the ratio of the crystallizing excipient to other excipients is adequate for crystallization.  Keep the protein concentration at 20 mg/mL (2%).

2. Suggest an alternate formulation with no crystallizing excipients and calculate the Tg'.  Keep the protein concentration at 20 mg/mL (2%)

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Other Subject: Suggest an alternate formulation with no crystallizing
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