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During 2021 we will continue to support students who need to study remotely due to the ongoing impacts of COVID-19 and travel restrictions. Make sure you check the location code when selecting a unit outline or choosing your units of study in Sydney Student. Find out more about what these codes mean. Both remote and on-campus locations have the same learning activities and assessments, however teaching staff may vary. More information about face-to-face teaching and assessment arrangements for each unit will be provided on Canvas.

Unit of study_

CHNG5605: Bio-Products: Laboratory to Marketplace

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.

Details

Academic unit Chemical and Biomolecular Engineering
Unit code CHNG5605
Unit name Bio-Products: Laboratory to Marketplace
Session, year
? 
Semester 2, 2020
Attendance mode Normal day
Location Camperdown/Darlington, Sydney
Credit points 6

Enrolment rules

Prohibitions
? 
None
Prerequisites
? 
None
Corequisites
? 
None
Available to study abroad and exchange students

No

Teaching staff and contact details

Coordinator Fariba Dehghani, fariba.dehghani@sydney.edu.au
Lecturer(s) Yi Shen , yi.shen@sydney.edu.au
Tutor(s) Juan Pablo Molina Ortiz , juan.molina@sydney.edu.au
Jacopo Giaretta, jacopo.giaretta@sydney.edu.au
Type Description Weight Due Length
Tutorial quiz Quizzes
on-line, open book
30% Multiple weeks 50 minutes
Outcomes assessed: LO5 LO6
Small test group assignment Preparation of a short report (might involve interview)
Assess team work, clarify that project scope and tasks are clear for groups
20% Week 06 Report submission, may interview 30 min
Outcomes assessed: LO1 LO2 LO3 LO4 LO5 LO6
Presentation group assignment Oral presentation
presentation by group member
15% Week 12 15 minutes
Outcomes assessed: LO1 LO6 LO5 LO4 LO2
Assignment group assignment Group project final report
Submitted report will be assessed for quality and tasks given to each group
35% Week 12 Project week 3-12, Min 3 hr per week
Outcomes assessed: LO1 LO6 LO5 LO4 LO3 LO2
group assignment = group assignment ?
  • Quizzes: Four multiple-choice and short-answer tests are given on selected topics. The tests are open-book and include topics covered during classes and/or in suggested readings.
  • Group project final report: Groups will be nominated in week 2 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 related to the compound of choice and will include the following tasks: pharmacological basis of the therapeutic ingredient selected, market and IP survey, formulation, production aspects, and compliance to good manufacturing guidelines. 

Detailed information for each assessment can be found on Canvas.

Assessment criteria

The University awards common result grades, set out in the Coursework Policy 2014 (Schedule 1).

As a general guide, a high distinction indicates work of an exceptional standard, a distinction a very high standard, a credit a good standard, and a pass an acceptable standard.

Result name

Mark range

Description

High distinction

85 - 100

 

Distinction

75 - 84

 

Credit

65 - 74

 

Pass

50 - 64

 

Fail

0 - 49

When you don’t meet the learning outcomes of the unit to a satisfactory standard.

For more information see sydney.edu.au/students/guide-to-grades.

Late submission

In accordance with University policy, these penalties apply when written work is submitted after 11:59pm on the due date:

  • Deduction of 5% of the maximum mark for each calendar day after the due date.
  • After ten calendar days late, a mark of zero will be awarded.

Special consideration

If you experience short-term circumstances beyond your control, such as illness, injury or misadventure or if you have essential commitments which impact your preparation or performance in an assessment, you may be eligible for special consideration or special arrangements.

Academic integrity

The Current Student website provides information on academic honesty, academic dishonesty, and the resources available to all students.

The University expects students and staff to act ethically and honestly and will treat all allegations of academic dishonesty or plagiarism seriously.

We use similarity detection software to detect potential instances of plagiarism or other forms of academic dishonesty. If such matches indicate evidence of plagiarism or other forms of dishonesty, your teacher is required to report your work for further investigation.

WK Topic Learning activity Learning outcomes
Week 01 1. Pharmaceutical drugs, economics and life style; 2. Introduction to the “Bio-products: laboratory to marketplace” course (3 hr) LO4
Week 02 Biomaterials (3 hr) LO1 LO4
Week 03 Biomedical scale-up: Market Survey and analysis (3 hr) LO1 LO4 LO6
Week 04 Drug formulation-part 1 (3 hr) LO1 LO3 LO5
Week 05 Drug Formulation-part 2 (3 hr) LO1 LO3
Week 06 Advances in food processing (3 hr) LO1 LO3 LO6
Week 07 Good Manufacturing Practice (3 hr) LO1 LO3 LO4
Week 08 Sterilization of biomedical products (3 hr) LO2 LO5 LO6
Week 09 Good Manufacturing Practice and Validation (3 hr) LO1 LO2
Week 10 Pharmaceutical Processing (3 hr) LO1 LO2 LO3 LO5
Week 11 Intellectual property for commercialisation (3 hr) LO1 LO2 LO3 LO6
Week 12 Presentation of Projects (3 hr) LO1 LO3 LO4 LO6

Attendance and class requirements

Study commitment: Project work is to be completed in student’s own time. Students are expected to spend about six hours of study outside the specified contact period.

Study commitment

Typically, there is a minimum expectation of 1.5-2 hours of student effort per week per credit point for units of study offered over a full semester. For a 6 credit point unit, this equates to roughly 120-150 hours of student effort in total.

Learning outcomes are what students know, understand and are able to do on completion of a unit of study. They are aligned with the University’s graduate qualities and are assessed as part of the curriculum.

At the completion of this unit, you should be able to:

  • LO1. utilise team-working skills to review, analyse, and consolidate knowledge in a technical report about the manufacturing of a biomedical product
  • LO2. document compliance with good-manufacturing guidelines for food, pharmaceuticals and biomedical products.
  • LO3. write an in-depth technical report
  • LO4. undertake an evaluation of the potential market for new biomedical products
  • LO5. explain key terms, principles and issues of food, pharmaceutical and biomedical manufacturing, including physical processes, GMP related issues, aspects of marketing and clinical trials
  • LO6. analyse production requirements and determine appropriate manufacturing process stages for a given food or biomedical product.

Graduate qualities

The graduate qualities are the qualities and skills that all University of Sydney graduates must demonstrate on successful completion of an award course. As a future Sydney graduate, the set of qualities have been designed to equip you for the contemporary world.

GQ1 Depth of disciplinary expertise

Deep disciplinary expertise is the ability to integrate and rigorously apply knowledge, understanding and skills of a recognised discipline defined by scholarly activity, as well as familiarity with evolving practice of the discipline.

GQ2 Critical thinking and problem solving

Critical thinking and problem solving are the questioning of ideas, evidence and assumptions in order to propose and evaluate hypotheses or alternative arguments before formulating a conclusion or a solution to an identified problem.

GQ3 Oral and written communication

Effective communication, in both oral and written form, is the clear exchange of meaning in a manner that is appropriate to audience and context.

GQ4 Information and digital literacy

Information and digital literacy is the ability to locate, interpret, evaluate, manage, adapt, integrate, create and convey information using appropriate resources, tools and strategies.

GQ5 Inventiveness

Generating novel ideas and solutions.

GQ6 Cultural competence

Cultural Competence is the ability to actively, ethically, respectfully, and successfully engage across and between cultures. In the Australian context, this includes and celebrates Aboriginal and Torres Strait Islander cultures, knowledge systems, and a mature understanding of contemporary issues.

GQ7 Interdisciplinary effectiveness

Interdisciplinary effectiveness is the integration and synthesis of multiple viewpoints and practices, working effectively across disciplinary boundaries.

GQ8 Integrated professional, ethical, and personal identity

An integrated professional, ethical and personal identity is understanding the interaction between one’s personal and professional selves in an ethical context.

GQ9 Influence

Engaging others in a process, idea or vision.

Outcome map

Learning outcomes Graduate qualities
GQ1 GQ2 GQ3 GQ4 GQ5 GQ6 GQ7 GQ8 GQ9
No significant changes has been made, since this unit was offered in the previous years.

Disclaimer

The University reserves the right to amend units of study or no longer offer certain units, including where there are low enrolment numbers.

To help you understand common terms that we use at the University, we offer an online glossary.