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Unit outline_

CHNG5605: Bio-Products: Laboratory to Marketplace

Semester 2, 2024 [Normal day] - Camperdown/Darlington, Sydney

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.

Unit details and rules

Academic unit Chemical and Biomolecular Engineering
Credit points 6
Prerequisites
? 
None
Corequisites
? 
None
Prohibitions
? 
None
Assumed knowledge
? 

None

Available to study abroad and exchange students

No

Teaching staff

Coordinator Fariba Dehghani, fariba.dehghani@sydney.edu.au
The census date for this unit availability is 2 September 2024
Type Description Weight Due Length
Skills-based evaluation Quiz 1
on-line, open book
13.3% Week 04
Due date: 23 Aug 2024 at 23:59

Closing date: 23 Jun 2024
one hour
Outcomes assessed: LO5 LO6
Assignment Submission of interim report
Assess team work, clarify that project scope and tasks are clear for groups
15% Week 07
Due date: 13 Sep 2024 at 23:59
Report, max.10 pages, interview
Outcomes assessed: LO1 LO2 LO3 LO4 LO5 LO6
Skills-based evaluation Quiz 2
on line quiz, open book, see canvas for detail
13.4% Week 08
Due date: 20 Sep 2024 at 23:59

Closing date: 20 Sep 2024
one hour
Outcomes assessed: LO1 LO6 LO5 LO2
Skills-based evaluation Quiz 3
open book quiz based on lectures from week 9-12
13.3% Week 12
Due date: 25 Oct 2024 at 23:59

Closing date: 25 Oct 2024
one hour
Outcomes assessed: LO1 LO6 LO5 LO2
Presentation group assignment Oral presentation
presentation by group members
15% Week 13
Due date: 30 Oct 2024 at 02:00
15 minutes
Outcomes assessed: LO1 LO2 LO3 LO4 LO5 LO6
Assignment group assignment Group project final report
Submitted report will be assessed for quality and tasks given to each group
30% Week 13
Due date: 03 Nov 2024 at 23:59

Closing date: 03 Nov 2024
maximum 30 pages
Outcomes assessed: LO1 LO2 LO3 LO4 LO5 LO6
group assignment = group assignment ?

Assessment summary

  • Quizzes: There will be different sets of questions including multiple-choice, descriptive answers and short-answer tests based on the lectures, additional materials and set of questions that are given to students during the semester.
  • 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 they will select topics that will be provided in canvas.  The group need to spend approximately 5 hours each week on this project to ensure they can submit a comprehensive report and presentation by week 13.
  • Each group also need to submit a short report in week 7 (details are provided in Canvas). There may be an interview after the submission of report to make sure that the tasks for projects are clear. Further details for submission of report are available in course outline/cnavas.  
  • 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 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.

Academic integrity

The Current Student website provides information on academic integrity 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 integrity breaches seriously.

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

Use of generative artificial intelligence (AI) and automated writing tools

You may only use generative AI and automated writing tools in assessment tasks if you are permitted to by your unit coordinator. If you do use these tools, you must acknowledge this in your work, either in a footnote or an acknowledgement section. The assessment instructions or unit outline will give guidance of the types of tools that are permitted and how the tools should be used.

Your final submitted work must be your own, original work. You must acknowledge any use of generative AI tools that have been used in the assessment, and any material that forms part of your submission must be appropriately referenced. For guidance on how to acknowledge the use of AI, please refer to the AI in Education Canvas site.

The unapproved use of these tools or unacknowledged use will be considered a breach of the Academic Integrity Policy and penalties may apply.

Studiosity is permitted unless otherwise indicated by the unit coordinator. The use of this service must be acknowledged in your submission as detailed on the Learning Hub’s Canvas page.

Outside assessment tasks, generative AI tools may be used to support your learning. The AI in Education Canvas site contains a number of productive ways that students are using AI to improve their learning.

Simple extensions

If you encounter a problem submitting your work on time, you may be able to apply for an extension of five calendar days through a simple extension.  The application process will be different depending on the type of assessment and extensions cannot be granted for some assessment types like exams.

Special consideration

If exceptional circumstances mean you can’t complete an assessment, you need consideration for a longer period of time, or if you have essential commitments which impact your performance in an assessment, you may be eligible for special consideration or special arrangements.

Special consideration applications will not be affected by a simple extension application.

Using AI responsibly

Co-created with students, AI in Education includes lots of helpful examples of how students use generative AI tools to support their learning. It explains how generative AI works, the different tools available and how to use them responsibly and productively.

Support for students

The Support for Students Policy 2023 reflects the University’s commitment to supporting students in their academic journey and making the University safe for students. It is important that you read and understand this policy so that you are familiar with the range of support services available to you and understand how to engage with them.

The University uses email as its primary source of communication with students who need support under the Support for Students Policy 2023. Make sure you check your University email regularly and respond to any communications received from the University.

Learning resources and detailed information about weekly assessment and learning activities can be accessed via Canvas. It is essential that you visit your unit of study Canvas site to ensure you are up to date with all of your tasks.

If you are having difficulties completing your studies, or are feeling unsure about your progress, we are here to help. You can access the support services offered by the University at any time:

Support and Services (including health and wellbeing services, financial support and learning support)
Course planning and administration
Meet with an Academic Adviser

WK Topic Learning activity Learning outcomes
Ongoing The approximate time to study course content is about 7 hours per week. Individual study (84 hr) LO1 LO2 LO3 LO4 LO5 LO6
Week 01 Introduction to the UoS Bio-product laboratory to market place, Biomaterials for medical devices Lecture and tutorial (3 hr) LO1 LO4
Week 02 Biomedical scale-up: Market Survey and analysis Lecture and tutorial (3 hr) LO1 LO4 LO6
Week 03 Drug formulation Lecture and tutorial (3 hr) LO1 LO3 LO5
Week 04 Drug delivery Lecture and tutorial (3 hr) LO1 LO3
Week 05 Pharmaceutical drugs, economics and life style; Lecture and tutorial (3 hr) LO4
Week 06 Food Processing and Cellular Agriculture Lecture and tutorial (3 hr) LO1 LO3 LO6
Week 07 Good Manufacturing Practice Lecture and tutorial (3 hr) LO1 LO3 LO4
Week 08 Sterilization of biomedical products Lecture and tutorial (3 hr) LO2 LO5 LO6
Week 09 Good Manufacturing Practice and Validation Lecture and tutorial (3 hr) LO1 LO2
Week 10 Pharmaceutical Processing Lecture and tutorial (3 hr) LO1 LO2 LO3 LO5
Week 11 Intellectual property and commercialisation Lecture and tutorial (3 hr) LO1 LO2 LO3 LO6
Week 12 Guest speaker Lecture and tutorial (3 hr) LO1 LO4 LO5 LO6
Week 13 Presentation and report submission Lecture and tutorial (3 hr) LO1 LO2 LO3 LO4 LO5 LO6

Attendance and class requirements

Study commitment: Project work is to be completed in student’s own time. Students are expected to spend about seven hours of study per week 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

This section outlines changes made to this unit following staff and student reviews.

No significant changes have been made since this unit was last offered. I have updated the date for the assessments.

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.