BIO07016 2013 BIOPHARMACEUTICALS 2

General Details

Full Title
BIOPHARMACEUTICALS 2
Transcript Title
BIOPHARMACEUTICALS
Code
BIO07016
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
07 - NFQ Level 7
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2013 - Full Academic Year 2013-14
End Term
2019 - Full Academic Year 2019-20
Author(s)
Mary Heneghan
Programme Membership
SG_JSCIE_X06 201400 Certificate
Description

This course aims to provide the student with a broad understanding of the various aspects of Biopharmaceutical production. The module will explore the technologies employed during upstream processing, downstream processing, formulation, fill-finish and delivery of Biopharmaceuticals.

Learning Outcomes

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

1.

Outline the various technologies and disciplines involved in the production of Biopharmaceuticals.

2.

Identify and evaluate the key factors that are involved in the design of an upstream bioprocessing system. 

3.

Describe and analyse the various approaches to downstream purification including chromatographic techniques, filtration technology, centrifugation, electrophoresis & viral exclusion techniques.

4.

Formulate and communicate judgements with regard to challenges in the formulation of biopharmaceuticals and explain the principal stages of sterile fill-finish operations.

5.

Demonstrate knowledge of the key elements in a systematic approach to Biopharmaceutical Process Validation.

6.

Compare routes of delivery for biopharmaceuticals (e.g. pulmonary, parenteral, transdermal) and evaluate current and novel drug delivery systems designed for biopharmaceuticals.

7.

Recognise ethical and regulatory issues relating to the biopharmaceutical industry.

Module Assessment Strategies

Assessment of the Biopharmaceuticals 2 module will include both continuous assessment and a terminal exam. Continuous assessment  will involve a range of assessment types including  case studies and  multiple choice quizzes.  A key focus of this module is to develop the student's team skills. To achieve this, students will be assigned a group project and be expected to participate constructively within a complex team environment. The team project will require the student's to work together to solve complex technical problems, plan for effective project implementation and manage the organisation of tasks, people and resources.

Module Dependencies

Prerequisites
None
Co-requisites
None
Incompatibles
None

Indicative Syllabus

The range of topics covered will include some of the following:

Upstream processing:

  • Fermentation Technology
  • Key features of bioreactor design  
  • Describe the main aspects of bioreactor control and operation
  • Bioreactor modes of operation 

Downstream processing:

  • Chromatographic techniques
  • Filtration technology
  • Centrifugation
  • Electrophoresis 
  • Viral exclusion techniques

Formulation-Fill Finish:

  • Aspects of preformulation of relevance to Biopharmaceutical formulation 
  • Dosage forms: Liquid, Frozen liquid, Solid Lyophilized (freeze-dried) etc
  • Main types of excipients (stabilizers) used in biopharmaceutical formulation.
  • Lyophilization Technology.
  • Sterile fill-finish operations for biopharmaceuticals.

Validation:

  • Overview of Validation Methodologies with specific application to Biopharmaceutical Manufacture.   
  • Risk Identification, Risk Assessment and Risk Management for Biopharmaceutical Manufacture e.g. FMEA.
  • Process Validation for Upstream and  Downstream Processing
  • Validation Methodology for Viral Control of Biopharmaceuticals. 

Drug Delivery:

  • Routes of Administration: Parenteral, Oral, Pulmonary, Nasal, Transdermal etc
  • Controlled release
  • Targeted delivery 
  • Specialised delivery systems 

 

 

 

 

 

Coursework & Assessment Breakdown

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

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Case Study Continuous Assessment UNKNOWN 10 % Week 9 4
2 Multiple Choice Continuous Assessment UNKNOWN 20 % OnGoing 1,2,3,4,5,6
3 Open Book Exam Continuous Assessment UNKNOWN 10 % OnGoing 5,7
4 Group Project Continuous Assessment UNKNOWN 20 % Week 12 2,3,4,6

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam Final Exam UNKNOWN 40 % End of Term 1,2,3,4,5,6,7
             
             

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Tiered Classroom Lecture 2 Weekly 2.00
Group Learning Flat Classroom Group Learning 1 Weekly 1.00
Independent Learning UNKNOWN Self Study 4 Weekly 4.00
Total Full Time Average Weekly Learner Contact Time 3.00 Hours

Module Resources

Non ISBN Literary Resources

Biopharmaceuticals. Walsh, Gary. Wiley, 2003.

'Process Validation of Protein Manufacturing'. PDA Journal of Pharmaceutical Science and Technology. Technical Report No. 42.

Pharmaceutics: The Science of Dosage Form Design (2nd edn). Aulton ME. Churchill. Livingston, 2002.

'Biotechnology - Quality Assurance and Validation' by K.E Avis, C.M.Wagner and V.L. Wu. Interpharm / CRC 1999.  ISBN - 1-57491-089-2.

Other Resources

None

Additional Information

None