BIO08056 2020 Formulation Fill Finish and Delivery of Biopharmaceuticals

Critically discuss the 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.

Perform research and a series of laboratory experiments relating to formulation/fill-finish, and then analyse, evaluate, draw reasoned conclusions and generate a report.

This module is taught by lectures supported by self-directed reading material, and project assignments involving laboratory practical work. A range of Computer-Aided Learning (CAL) packages are also used to support this module. Students are provided with electronic materials for self-assessment and preparation for examinations. Self-directed, student- centred, independent learning is also encouraged through completion of module coursework. The laboratory practical work will be carried out at National Institute for Bioprocessing Research and Training (NIBRT), Blackrock over 3 days.

Class Test [50%]

Includes short form assessment exams MCQ/short answer questions and problems and longer essay based assignment. This will be 5 assessments, worth 25% each.

Project [50%]

A project/lab. practical will be undertaken over the course of the module and the outcomes will be assessed as a written report (2000 words for 40% of module marks) together with a project presentation (10 minutes for 10% of module marks) at the end of the module.

Feedback: Students will be provided with the assessment criteria for each assignment. Feedback will be written and detailed against each criteria as appropriate. Further information and guidelines on assignments, assessment criteria and submission schedule is provided in the module handout.

100% Coursework                                                                                0% Examination

N/A

This module will blend lecture material with applied content that includes the following: Aspects of pre-formulation 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.