BIO08028 2019 Formulation and Delivery Systems of Biopharmaceuticals

General Details

Full Title
Formulation and Delivery Systems of Biopharmaceuticals
Transcript Title
Formulation and Delivery Syste
Code
BIO08028
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
08 - NFQ Level 8
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Mary Heneghan
Programme Membership
SG_SMEDI_H08 201900 Bachelor of Science (Honours) in Science in Medical Biotechnology SG_SMEDI_K08 201900 Level 8 Honours Degree Add-on in Science in Medical Biotechnology
Description

The aim of this module is to provide students with an understanding of the main considerations in the formulation of a biopharmaceutical drug. The module will introduce students to the challenges encountered in the formulation of biopharmaceutical products. They will gain an understanding of the key steps in preformulation, formulation, lyophilisation and fill-finish operations. This module will also address current and emerging drug delivery systems for therapeutic peptides, proteins and nucleic acid based drugs.

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

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

2.

Describe the fundamental objectives of preformulation.

3.

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

4.

Explain the principles and applications of freeze-drying technology.

5.

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

Teaching and Learning Strategies

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).

Module Assessment Strategies

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. 

Repeat Assessments

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. 

Module Dependencies

Co-requisites
None
Incompatibles
None

Indicative Syllabus

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

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
40 %
End of Semester / Year Formal Exam
60 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Case Study Continuous Assessment Assessment 20 % Week 8 1,2
2 Multiple Choice Continuous Assessment UNKNOWN 20 % OnGoing 1,2,3,4,5
             

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam Final Exam UNKNOWN 60 % End of Term 1,2,3,4,5
             
             

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Tiered Classroom Lecture 2 Weekly 2.00
Independent Learning UNKNOWN Self Study 5 Weekly 5.00
Total Full Time Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Recommended Reading
2013-04-29 Biopharmaceuticals John Wiley & Sons
ISBN 9781118687383 ISBN-13 1118687388

The latest edition of this highly acclaimed textbook, provides a comprehensive and up-to-date overview of the science and medical applications of biopharmaceutical products. Biopharmaceuticals refers to pharmaceutical substances derived from biological sources, and increasingly, it is synonymous with 'newer' pharmaceutical substances derived from genetic engineering or hybridoma technology. This superbly written review of the important areas of investigation in the field, covers drug production, plus the biochemical and molecular mechanisms of action together with the biotechnology of major biopharmaceutical types on the market or currently under development. There is also additional material reflecting both the technical advances in the area and detailed information on key topics such as the influence of genomics on drug discovery.

Module Resources

Non ISBN Literary Resources

Ho, R. (2013). Biotechnology and Biopharmaceuticals. Wiley-Blackwell.

Jørgensen, L. and Nielsen, H. (2009). Delivery technologies for biopharmaceuticals. Chichester, West Sussex: John Wiley.

Morishita, M. and Park, K. (2010). Biodrug delivery systems. New York: Informa Healthcare USA.

 

 

Journal Resources

Additional reading and resources will be recommended by the lecturer.

URL Resources

Additional reading and resources will be recommended by the lecturer.

Other Resources

Additional reading and resources will be recommended by the lecturer

Additional Information

None