CHNG5605: Bio-Products: Laboratory to Marketplace (2014 - Semester 2)

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Unit: CHNG5605: Bio-Products: Laboratory to Marketplace (6 CP)
Mode: Normal-Day
On Offer: Yes
Level: Postgraduate
Faculty/School: School of Chemical and Biomolecular Engineering
Unit Coordinator/s: A/Prof Dehghani, Fariba
Session options: Semester 2
Versions for this Unit:
Campus: Camperdown/Darlington
Pre-Requisites: None.
Brief Handbook Description: The objectives of the course are to provide students with an overview of biochemical and pharmaceutical industry. It will give students an insight into drug delivery systems and formulation; how therapeutic drugs work; and a general overview of biochemical and pharmaceutical marketing. The design and management of clinical trials, which are key factors for development of any new therapeutic agent will also be covered in the course. The challenges for commercialisation of innovative methods and/or biochemical and pharmaceutical products and aspects of intellectual property protection will be elaborated. Ultimately the aspects of Good Manufacturing Practice (GMP) and international legislation for marketing pharmaceutical products will be illuminated.

Lectures in this course will be delivered by both University of Sydney staff and by a number of visiting professional representatives from industry and government agencies. We will also arrange a site visit for a bio-manufacturing company as warranted.

When you successfully complete this course you acquire knowledge about drug formulation, pharmaceutical processing including physical processes, legislation governing the bio-manufacturing and commercialisation of biochemicals and pharmaceuticals. The information would be beneficial for your future career in pharmaceutical manufacturing companies.

Students are encouraged to engage in an interactive environment for exchange of information. This course will be assessed by quizzes, assignments, oral presentation and final report.This unit of study is offered as an advanced elective unit of study to final year undergraduate students. Students may be required to attend lectures off-campus.
Assumed Knowledge: None.
Additional Notes: This course is for Master degree students and also is offered as an elective course for fourth year students. .
Timetable: CHNG5605 Timetable
Time Commitment:
# Activity Name Hours per Week Sessions per Week Weeks per Semester
1 Lecture 2.00 13
2 Project Work - own time 6.00 13
T&L Activities: Project Work - own time: Projects and self assisted learning.

Students are expected to spend about six hours of study outside the specified contact period.

Attributes listed here represent the key course goals (see Course Map tab) designated for this unit. The list below describes how these attributes are developed through practice in the unit. See Learning Outcomes and Assessment tabs for details of how these attributes are assessed.

Attribute Development Method Attribute Developed
Students work through the stages of designing a manufacturing process for a biomedical product, as a group project. Design (Level 3)
Students are familiarised with concepts and principals of biomaterials and pharmaceuticals manufacturing and practice applying them in the group project and presentation tasks. Engineering/IT Specialisation (Level 3)
Students research and apply manufacturing guidelines for biomedical products and practice applying them to a specific case as part of the group project. Information Seeking (Level 3)
Students are required to produce an in-depth technical report of substantial length at an industry standard as part of the group project. Communication (Level 4)
Students analyse, interpret and implement principles of good manufacturing practice in biomedical production. Professional Conduct (Level 4)

For explanation of attributes and levels see Engineering & IT Graduate Outcomes Table.

Learning outcomes are the key abilities and knowledge that will be assessed in this unit. They are listed according to the course goal supported by each. See Assessment Tab for details how each outcome is assessed.

Engineering/IT Specialisation (Level 3)
1. Ability to explain key terms, principles and issues of pharmaceutical and biomaterials manufacturing, including physical processes, GMP related issues, pharmaceutical marketing and clinical trials.
2. Ability to critically discuss the pharmacological basis of a biomedical product.
Design (Level 3)
3. Ability to analyse production requirements and determine appropriate manufacturing process stages for a given biomedical product.
Professional Conduct (Level 4)
4. Ability to undertake an evaluation of the potential market for new biomedical product.
5. Ability to document compliance with good-manufacturing guidelines for biomaterials production.
Communication (Level 4)
7. Ability to write an in-deph technical report (30 to 40 pages).
8. Ability to deliver an oral presentation at a professional standard in a team format.
Project and Team Skills (Level 2)
6. Ability to work in a team.
Assessment Methods:
# Name Group Weight Due Week Outcomes
1 Quizzes No 25.00 Multiple Weeks 1,
2 Group Project - Initial Report (4 pages) Yes 20.00 Week 8 2, 3, 4, 5, 7,
3 Group Project-Final Report Yes 35.00 Week 12 2, 3, 4, 5, 7,
4 Oral Presentation Yes 15.00 Week 13 8,
5 Attendance/Teamwork Yes 5.00 Multiple Weeks 6,
Assessment Description: Quiz. Three to four multiple-choice and short-answer tests are given on selected topics. Thirty minute time slots are allocated for quizzes during classes. The tests are open-book and include topics covered during classes and/or in suggested readings.

Group Project. Groups will be nominated in week 3 and a class of therapeutic compounds will be assigned to each group. The groups will be asked to select a pharmacological active compound by week 4. The group report will be relate to the compound of choice and will include the following tasks:

1. Pharmacological basis of the therapeutic ingredient selected

2. Market and IP survey

3. Formulation

4. Production aspects

5. Compliance to good manufacturing guidelines

Each group will submit twice. The initial submission will be a short report (max. 4 pages) and discuss progress so far and issues with the project. The final report will have a maximum length of 30 pages excluding references and attachments and should be submitted both in hard copy format and electronically. All team members should participate in writing. Cooperation within groups will be assessed by peer evaluations submitted in the same weeks as the group reports.

Each group will identify and approach aspects that are more relevant to the topic. It is expected that students will develop an understanding of the principles involved and an appropriate vocabulary. Well-organised and properly expressed basic principles are valued more than a shallow approach to wide and complex biomedical topics.

Oral presentation. Each group must give an oral presentation of about 20 minutes. Presentations must involve ALL TEAM MEMBERS. Grading of the presentations will consist of the group component for overall quality as well as individual contributions by team members.

Class attendance/teamwork. It is essential to attend lectures and the class attendance will be recorded randomly. Each group will need to submit a time-sheet for their group meeting, brief summary of minutes (i.e. overview of the meeting outcomes, contribution of group members at each meeting, future plans and activities). An excel spreadsheet can be used to record the information in tabular form. This report will be used to asses the group and individual contributions of group members.
Grading:
Grade Type Description
Standards Based Assessment Final grades in this unit are awarded at levels of HD for High Distinction, DI (previously D) for Distinction, CR for Credit, PS (previously P) for Pass and FA (previously F) for Fail as defined by University of Sydney Assessment Policy. Details of the Assessment Policy are available on the Policies website at http://sydney.edu.au/policies . Standards for grades in individual assessment tasks and the summative method for obtaining a final mark in the unit will be set out in a marking guide supplied by the unit coordinator.
Policies & Procedures: See the policies page of the faculty website at http://sydney.edu.au/engineering/student-policies/ for information regarding university policies and local provisions and procedures within the Faculty of Engineering and Information Technologies.

Note that the "Weeks" referred to in this Schedule are those of the official university semester calendar https://web.timetable.usyd.edu.au/calendar.jsp

Week Description
Week 1 Pharmaceutical Drugs, Economics and Life Style ?
Introduction to the “Biomedical Processing” course
Week 2 Drug Delivery
Week 3 Patenting and IP Strategy
Week 4 Clinical Trials and Pharmacokinetic of Drugs
Week 5 Good Manufacturing Practice
Week 6 Validation of sterilization process
Week 7 Good Manufacturing Practice
Week 8 Development in biotechnology
Assessment Due: Group Project - Initial Report (4 pages)
Week 9 Drug discovery from natural sources
Week 10 Drug Delivery/formulation
Week 11 Industrial Perspectives on Biomaterials Research
Week 12 Site visit
Assessment Due: Group Project-Final Report
Week 13 Group presentation
Assessment Due: Oral Presentation

Course Relations

The following is a list of courses which have added this Unit to their structure.

Course Year(s) Offered
Biomedical Engineering / Law 2013, 2014
Biomedical Engineering / Arts 2013, 2014
Biomedical Engineering / Commerce 2013, 2014
Biomedical Engineering / Medical Science 2013, 2014
Biomedical Engineering / Project Management 2013, 2014
Biomedical Engineering / Science 2013, 2014
Biomedical - Chemical and Biomolecular Major 2013, 2014, 2015
Biomedical - Electrical Major 2013, 2014
Biomedical - Information Technology Major 2013, 2014, 2015
Biomedical - Mechanical Major 2013, 2014, 2015
Biomedical - Mechatronics Major 2013, 2014, 2015
Chemical & Biomolecular 2010, 2011, 2012, 2013, 2014, 2015
Chemical & Biomolecular Engineering / Arts 2011, 2012, 2013, 2014
Chemical & Biomolecular Engineering / Commerce 2010, 2011, 2012, 2013, 2014
Chemical & Biomolecular Engineering / Medical Science 2011, 2012, 2013, 2014
Chemical & Biomolecular Engineering / Science 2011, 2012, 2013, 2014
Chemical & Biomolecular Engineering / Law 2012, 2013, 2014
Chemical & Biomolecular Engineering / Project Management 2012, 2013, 2014
Biomedical /Science 2015
Biomedical - Electrical Major 2015
Graduate Certificate in Engineering 2011, 2012, 2013, 2014, 2015
Master of Engineering (2013+ ) 2013, 2014, 2015
Master of Engineering (Biophysical Processes) 2012
Master of Engineering (Chemical and Biomolecular) 2012
Master of Professional Engineering (Chemical & Biomolecular) 2010, 2011, 2012, 2013, 2014, 2015

Course Goals

This unit contributes to the achievement of the following course goals:

Attribute Practiced Assessed
Engineering/IT Specialisation (Level 3) Yes 36.69%
Design (Level 3) Yes 11.69%
Professional Conduct (Level 4) Yes 23.38%
Communication (Level 4) Yes 23.25%
Information Seeking (Level 3) Yes 0%
Project and Team Skills (Level 2) No 5%

These goals are selected from Engineering & IT Graduate Outcomes Table which defines overall goals for courses where this unit is primarily offered. See Engineering & IT Graduate Outcomes Table for details of the attributes and levels to be developed in the course as a whole. Percentage figures alongside each course goal provide a rough indication of their relative weighting in assessment for this unit. Note that not all goals are necessarily part of assessment. Some may be more about practice activity. See Learning outcomes for details of what is assessed in relation to each goal and Assessment for details of how the outcome is assessed. See Attributes for details of practice provided for each goal.