Full Title FORMULATION FILL FINISH AND DELIVERY OF BIOPHARMACEUTICALS

Short Title Formulation of Biologics

Code BIO08047
Level 08
Credit 05

Author Butler, Mary
Department Life 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 and also addresses current and emerging drug delivery systems.

Indicative Syllabus
Aspects of Preformulation of relevance to Biopharmaceutical formulation e.g. physicochemical principles that govern protein stability.

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 Technology.

    Lyophilization Technology.

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

    Drug Delivery: Controlled release, Targeted delivery and Specialised delivery systems e.g. liposomes, nanoparticles, microparticles.

    Learning Outcomes
    On completion of this module the learner will/should be able to
    1. Formulate and communicate judgements with regard to challenges in the formulation of biopharmaceuticals.

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

    3. Explain the principles and applications of typical fill-finish and freeze-drying technologies.

    4. Analyse, evaluate and draw conclusions from data presented in problem solving exercises.

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

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


    Assessment Strategies
    The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following; short form assessment exams including multiple choice and short answer questions/problems, project assignments/reports, essays and oral presentations.

    The miniproject is a MANDATORY form of assessment for any modules on this programme with a miniproject component.

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

    Coursework Assessment Breakdown %
    Course Work / Continuous Assessment 100 %

    Coursework Assessment Breakdown

    Description Outcome Assessed % of Total Assessment Week
    Continuous Assessment May take the form of MCQ/SAQ or essay type assessment 1,2,3,4 50 OnGoing
    Project Project and Presentation 5,6 50 End of Term


    End Exam Assessment Breakdown

    Description Outcome Assessed % of Total Assessment Week


    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 Lecture 2 Weekly 2.00
    Independent Learning Not Specified Self-directed learning and continuous assessment 70 Once Per Semester 4.67

    Total Average Weekly Learner Workload 2.00 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
    Protein Formulation and Delivery by E. J. Mc Nally. Publisher; Informa Health Care, New York. Year 2008.

    Therapeutic Peptides and Proteins. Formulation, Processing, and Delivery Systems by A. K. Banga. Second Edition. Publisher Taylor and Francis. Year 2006.
    Other Resources
    Various reading sources will be either provided or recommended by the module tutor.
    Url Resources
    Additional Info