Full Title Formulation and Fill-Finish.

Short Title Formulation and Fill-Finish.

Code BIO07013
Level 07
Credit 05

Author Tobin, Kieran
Department Applied Sciences

Subject Area Bio Tech/Eng/Chem
Attendence N/A%
Fee

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

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


  • Fill/Finish Technologies.

    Lyophilization Technologies.

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

    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.

    6.  Perform research on a relevant topic and analyse, evaluate and draw conclusions accordingly.                 

    7. Communicate scientific data in an appropriate format on this topic.


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

    Assessment Facilitites
    Online teaching technologies.

    Module Dependencies
    Pre Requisite Modules
    None
    Co Requisite Modules
    None
    Incompatible Modules
    None

    Coursework Assessment Breakdown %
    Course Work / Continuous Assessment 70 %
    End of Semester / Year Formal Examination 30 %

    Coursework Assessment Breakdown

    Description Outcome Assessed % of Total Assessment Week
    Continuous Assessment Short-form exams and assessments. 1,2,3,4,5,6,7 70 OnGoing


    End Exam Assessment Breakdown

    Description Outcome Assessed % of Total Assessment Week
    Final Exam 1,2,3,4,5 30 End of Term


    Distance Learning Mode Workload

    Type Location Description Hours Frequency Avg Weekly Workload

    Total Average Weekly Learner Workload 0.00 Hours

    Part Time Mode Workload

    Type Location Description Hours Frequency Avg Weekly Workload
    Lecture Distance Learning Suite Online lecture. 1 Weekly 1.00
    Directed Learning Not Specified Directed self-study. 4 Weekly 4.00

    Total Average Weekly Learner Workload 5.00 Hours

    Full Time Mode Workload

    Type Location Description Hours Frequency Avg Weekly Workload

    Total Average Weekly Learner Workload 0.00 Hours

    Online Learning Mode Workload

    Type Location Description Hours Frequency Avg Weekly Workload

    Total Average Weekly Learner Workload 0.00 Hours

    Resources
    Book 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.
    Other Resources
    None
    Url Resources
    Additional Info