ACE

PF6611: Biologics: Formulation and Dosage Form Design

Credit Weighting: 5
No. of Students: Min 10, Max 50.
Pre-requisite(s): None
Co-requisite(s): None
Teaching Period(s): Semester 3.
Teaching Methods: 6 x 3hr(s) Workshops; 50hr(s) Directed Study; 32hr(s) Other (self-directed study)
Module Co-ordinator: Dr Katie Ryan, School of Pharmacy.
Lecturer(s): Staff, School of Pharmacy.
Module Objective: To provide students with knowledge related to the formulation and dosage form design of biopharmaceutical.
Module Content: Physicochemical properties of protein-based therapies. Challenges to protein delivery. Protein-engineering and formulation approaches to overcome delivery challenges. Biotech products: handling, packaging, transport, storage.
Learning Outcome: On successful completion of this module, students should be able to:
  • Explain the key physicochemical properties to consider in the design of a protein formulation.
  • Describe challenges to protein delivery and protein-engineering and formulations approaches to overcome these challenges.
  • Explain parenteral packaging systems, special stability requirements of biotech products.
Assessment: Total Marks 100: Continuous Assessment 100 marks (written assignment, 70 marks; presentation, 30 marks).
Compulsory Elements: Continuous Assessment. Oral if required.
Penalties (for late submission of course/project work etc.): Where work is submitted up to and including 7 days late, 5% of the total marks available shall be deducted from the mark achieved. Where work is submitted up to and including 14 days late, 10% of the total marks available shall be deducted from the mark achieved. Work submitted 15 days late or more shall be assigned a mark of zero.
Pass Standard and any Special Requirements for Passing Module: 50%.
End of Year Written Examination Profile: No Formal Written Examination.
Requirements for Supplemental Examination: Marks in passed element(s) of Continuous Assessment are carried forward, Failed element(s) of Continuous Assessment must be repeated (as prescribed by the School of Pharmacy).

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