[Answered]: You have been assigned to develop a lyophilized…

You have been assigned to develop a lyophilized formulation for a new product. Intravenous administration showed a target of 80 mg was acceptable. The target dosage for subcutaneous administration with 80% bioavailability. Because it is subcutaneous, target 270-350 mOsm/kg for your dosage form. The pH should be 6.0 and the product is sensitive to shear and oxidation. The maximum protein concentration is 80 mg/mL. Use the table below for reference and show your work.a. (1 point) What is your proposed dose (0.5 points), protein concentration (0.5 points)? b. (6 points) Propose two formulations (including osmolality)? Provide rationale for each excipient chosen. (3 points per formulation) c. (2 points) What is your fill volume (1 point) reconstitution volume after lyophilization to achieve the same protein concentration as pre-lyophilization (1 point)? Note, due to the accuracy of syringes used for reconstitution, ensure the reconstitution volume requires no more than 0.1 mL accuracy (the volume should be x.x mL not x.xxx mL). d. (4 points) What are the Tg’ of your formulations (2 points each)?