BIO07013 2019 Formulation and Fill-Finish.

General Details

Full Title
Formulation and Fill-Finish.
Transcript Title
Formulation and Fill-Finish.
Code
BIO07013
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
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Paul Walsh, Mary Butler
Programme Membership
SG_SBIOP_J07 201900 Bachelor of Science in Science in Biopharmaceutical Science SG_SBIOP_E07 201900 Certificate in Science in Biopharma Processing L7
Description

This module aims to provide students with an understanding of the main considerations in the formulation and fill finish of a biopharmaceutical drug.  

Learning Outcomes

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

1.

 Describe the key principles of aseptic processing as they relate to drug fill-finish operations.    

2.

  Compare and contrast routes of delivery for biopharmaceuticals (e.g. pulmonary, parenteral, transdermal).  

3.

Describe the main filling and closure technologies and their control and operation.

4.

Explain the principles and applications of freeze-drying technology.

5.

Outline the typical quality control measures required for a fill-finish operation.

Teaching and Learning Strategies

N/A

Module Assessment Strategies

A combination of continuous assessment strategies, some laboratory experiments and an end-of-term exam.

Repeat Assessments

N/A

Indicative Syllabus

Aspects of preformulation of relevance to Biopharmaceutical formulation e.g. physicochemical principles that govern stability.

Routes of Administration: Parenteral, Oral, Pulmonary, Nasal, Transdermal etc

Formulation:

  1. Dosage forms: Liquid, Frozen liquid, Solid Lyophilized (freeze-dried) etc
  2. Main types of excipients (stabilizers) used in biopharmaceutical formulation.
  3. Packaging materials for biopharmaceuticals.

Fill/Finish Technologies.

Lyophilization Technologies.

Quality Control and batch release criteria for fill-finish operations.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
50 %
End of Semester / Year Formal Exam
50 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Continuous Assessment Short-form exams and assessments. Continuous Assessment Assessment 25 % Week 6 1,2,3,4,5
2 Multiple Choice Quiz Continuous Assessment Assessment 25 % Week 12 1,2,3,4,5
             

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam Final Exam Closed Book Exam 50 % End of Term 1,2,3,4,5
             
             

Part Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Distance Learning Suite Online lecture. 1 Weekly 1.00
Directed Learning Not Specified Directed self-study. 4 Weekly 4.00
Total Part Time Average Weekly Learner Contact Time 5.00 Hours

Module Resources

Non ISBN Literary Resources

Pharmaceutical Biotechnology: An Introduction for Pharmacists and Pharmaceutical Scientists, 2nd Edition. J. Daan and R. Sindelar. Publisher: Taylor and Francis. ISBN: 0415285003.

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

Journal Resources

N/A

URL Resources

N/A

Other Resources

None

Additional Information

None