BIO08028 2019 Formulation and Delivery Systems of Biopharmaceuticals

Formulate and communicate judgements with regard to challenges encountered in the formulation of biopharmaceuticals.

Describe the fundamental objectives of preformulation.

Evaluate the use of different excipients in formulation, and outline the primary stages of sterile fill-finish operations.

Explain the principles and applications of freeze-drying technology.

Compare routes of delivery for biopharmaceuticals and evaluate current and novel drug delivery systems designed for biopharmaceuticals.

This module will be delivered full-time. Lecture delivery will be the primary mode of dissemination for module theory. A variety of teaching and learning strategies will be employed to promote critical and reflective thinking, as well as research and evaluation skills. A KWL chart will be completed by the students at the start of the module to establish prior knowledge in relation to protein structure and instability pathways. This will inform teaching and guide student learning. Visualisation techniques will be employed where possible to bring difficult concepts to life and highlight their practical applications e.g. the use of video clips and students will be brought to the lab to observe a demonstration on the use of a freeze drier. Co-operative learning will be encouraged, whereby students will work together to complete revision activates (e.g. crosswords, double puzzles, word searches). These revision activities will be provided at the end of each topic. Students will produce a mind map to summarise and visually represent what they have learned.  A learning platform (such as moodle) will be used as a repository of educational resources and as a means of assessment (e.g. quizzes, uploading assignments and journals).

Assessment of the Formulation and Delivery Systems module will include both continuous assessment (40%) and a terminal exam (60%).  Continuous assessment will involve 2 multiple choice quizzes and a case study. The multiple choice quizzes will assess subject knowledge and will take place between weeks 4 and 12. The industry case study will require the student's to work within a limited time frame to employ advanced data analysing, synthesising and summarising skills in a scientific work setting. The final exam will examine the students knowledge of the module and assess the ability of students to communicate that knowledge in a suitable manner. Formative assessments will be conducted at the end of each topic to evaluate student comprehension, learning needs, and academic progress. These assessments will identify concepts that students are struggling to understand and skills they are having difficulty acquiring. 

If a student fails to achieve 40% in the module they will be required to resit the exam or write a theory assignment or a combination of these. Repeat assessments will be decided on a case by case basis, and will be informed by the amount and quality of continuous assessment submitted during the semester, and the performance of the student in the terminal exam. Examples of repeat assessment could include multiple choice quiz, case study evaluation or essay style questions on a given topic. 

Formulate and communicate judgements with regard to challenges encountered in the formulation of biopharmaceuticals.

• Protein Structure
• Glycosylation
• Chemical instability pathways
• Physical Instability pathways

Describe the fundamental objectives of preformulation.

• Domestic & International distribution
• Constituted vs. Lyophilised Formulations
• Unit dose or Multidose
• Physiochemical Factors to be considered for Protein Drug Formulations
• Characterisation studies
• Stability and stress testing
• Analytical assay development

Evaluate the use of different excipients in formulation, and outline the primary stages of sterile fill-finish operations.

• Dosage forms: Liquid, Frozen liquid, Solid Lyophilized (freeze-dried) etc.
• Freeze-thawing
• Function and main types of excipients (stabilizers) used in biopharmaceutical formulation.
• Aseptic filling
• Cleanroom
• Filtration technology
• Packaging materials for biopharmaceuticals.

Explain the principles and applications of freeze-drying technology.

• Desired characteristics of a lyophilised product
• Principals of lyophilisation
• Freezing
• Primary drying
• Secondary drying
• Lyophilisation equipment

Compare routes of delivery for biopharmaceuticals and evaluate current and novel drug delivery systems designed for biopharmaceuticals.

• First pass metabolism
• Routes of Administration: Parenteral, Oral, Pulmonary, Nasal, Transdermal etc
• Drug delivery - Controlled release
• Drug delivery - Targeted delivery
• Non parenteral delivery systems