Please suggest a specific candidate formulation (including protein…

Please suggest a specific candidate formulation (including protein concentration and all excipient concentrations) and what presentation you would propose to provide to the clinic to test your product. “In real life,” we would clearly perform experiments to confirm that these formulations we have suggested provide adequate stability (attributes remain where we want them to be for a useful duration).

You have been provided a molecule from research formulated in PBS (phosphate buffered saline). Solubility / viscosity appears to be difficult to manage above 80 mg/mL. Stability is less than ideal (especially at high pH) and the pI of the molecule is 8.2. Assume patient weight range of 60-100 kg.

Dose target 40 mg flat subcutaneous, aggregates with freeze / thaw, clipping (fragments) at low pH.

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