PF6610: BioPharmaceutical Technology and Processes

Credit Weighting: 10
No. of Students: Min 10, Max 50.
Pre-requisite(s): None
Co-requisite(s): None
Teaching Period(s): Semester 1.
Teaching Methods: 12 x 3hr(s) Lectures (lectures / workshops - blended learning); 80hr(s) Directed Study; 76hr(s) Other (self-directed study)
Module Co-ordinator: Dr John V (Eoin) Fleming, School of Biochemistry and Cell Biology.
Lecturer(s): Staff, School of Biochemistry and Cell Biology; Staff, School of Pharmacy.
Module Objective: To provide students with an introduction to pharmaceutical industrial processes - from the design and development of biological drugs, to the manufacture, purification and formulation of active ingredient.
Module Content: Introduction to pharmaceutical biotechnology. Principle and design of biological drugs. Vaccines. Recombinant therapeutic proteins. Introduction to antibodies and their derivatives (Including humanized monoclonals). Upstream and downstream processes in the manufacture of biopharmaceutical products. Choice and management of production cell line. Bioreactor design principles and practice. Expression, purification, characterization and analysis of protein drugs. Overview of fundamental unit operations (heat transfer, mass transfer, fluid dynamics). Downstream Processing (Filtration and Chromotography), Formulation Processes (Freezing/Thawing, Compounding, Pumping, Filling, Lyophilisation) and Packaging.
Learning Outcome: On successful completion of this module, students should be able to:
  • Explain the basic principles of pharmaceutical biotechnology.
  • Apply knowledge of molecular and cellular biology to the design and manufacture of biopharmaceutical drugs.
  • Assess the key parameters to be considered in the upstream and downstream processing of a sterile biopharmaceutical product.
  • Explain the principles and application of analytical methods commonly used to characterise biological drugs.
  • Demonstrate competency in writing and following SOP's for routine lab procedures.
  • Explain pharmaceutical processes involved in protein formulations.
  • Apply knowledge of pharmaceutical processes and identify the application of this process technology in an industrial setting.
  • Assess the key process parameters to be considered in designing a pharmaceutical process.
Assessment: Total Marks 200: Continuous Assessment 200 marks (Online Canvas quiz, 2 x 40 marks; 2,000 word written assignment, 2 x 60 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).

University College Cork

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