BIO08018 2011 FORMULATION FILL FINISH AND DELIVERY OF BIOPHARMACEUTICALS
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.
On completion of this module the learner will/should be able to;
Formulate and communicate judgements with regard to challenges in the formulation of biopharmaceuticals.
Compare routes of delivery for biopharmaceuticals (e.g. pulmonary, parenteral, transdermal) and evaluate current and novel drug delivery systems designed for biopharmaceuticals.
Explain the principles and applications of typical fill-finish and freeze-drying technologies.
Analyse, evaluate and draw conclusions from data presented in problem solving exercises.
Perform research on a relevant topic and analyse, evaluate and draw conclusions accordingly.
Communicate scientific data in an appropriate format on this topic.
Module 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.
Aspects of Preformulation of relevance to Biopharmaceutical formulation e.g. physicochemical principles that govern protein stability.
- Dosage forms: Liquid, Frozen liquid, Solid Lyophilized (freeze-dried) etc
- Main types of excipients (stabilizers) used in biopharmaceutical formulation.
- Packaging materials for biopharmaceuticals.
Routes of Administration: Parenteral, Oral, Pulmonary, Nasal, Transdermal etc
Drug Delivery: Controlled release, Targeted delivery and Specialised delivery systems e.g. liposomes, nanoparticles, microparticles.
Coursework & Assessment Breakdown
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||Continuous Assessment May take the form of MCQ/SAQ or essay type assessment||Continuous Assessment||UNKNOWN||50 %||OnGoing||1,2,3,4|
|2||Project Project and Presentation||Continuous Assessment||UNKNOWN||50 %||End of Term||5,6|
Part Time Mode 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|
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.
Various reading sources will be either provided or recommended by the module tutor.