Outline

Overview

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
Lecturer(s)	Yi Shen, yi.shen@sydney.edu.au

Type	Description	Weight	Due	Length
Skills-based evaluation	Quiz 1 on-line, open book	17%	Week 04 Due date: 03 Sep 2021 at 23:59	one hour
Outcomes assessed:
Assignment	Submission of interim report Assess team work, clarify that project scope and tasks are clear for groups	10%	Week 07 Due date: 22 Sep 2021 at 23:59	Report submission, maximum 10 pages.
Outcomes assessed:
Skills-based evaluation	Quiz 2 on line quiz, open book, see canvas for detail	17%	Week 08 Due date: 08 Oct 2021 at 23:59	one hour
Outcomes assessed:
Skills-based evaluation	Quiz 3 open book quiz based on lectures from week 9-12	16%	Week 12 Due date: 05 Nov 2021 at 23:59	one hour
Outcomes assessed:
Presentation	Oral presentation presentation by group members	10%	Week 13 Due date: 10 Nov 2021 at 02:00	15 minutes
Outcomes assessed:
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 2021 at 23:59	maximum 30 pages
Outcomes assessed:
= 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.

Learning support

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.

Weekly schedule

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

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

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.

Outcomes
Graduate qualities

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
Learning outcomes

Responding to student feedback

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.

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.

Current students

Overview

Overview

Unit details and rules

Teaching staff

Assessment

Assessment

Assessment summary

Assessment criteria

Late submission

Academic integrity

Learning support

Learning support

Simple extensions

Special consideration

Using AI responsibly

Weekly schedule

Weekly schedule

Attendance and class requirements

Study commitment

Learning outcomes

Learning outcomes

Graduate qualities

Outcome map

Responding to student feedback

Responding to student feedback

Disclaimer

On this page

Useful links

Media

Student links

About us

Connect

Current students

CHNG5605: Bio-Products: Laboratory to Marketplace

Semester 2, 2021 [Normal day] - Camperdown/Darlington, Sydney

Overview

Overview

Unit details and rules

Teaching staff

Assessment

Assessment

Assessment summary

Assessment criteria

Late submission

Academic integrity

Learning support

Learning support

Simple extensions

Special consideration

Using AI responsibly

Weekly schedule

Weekly schedule

Attendance and class requirements

Study commitment

Learning outcomes

Learning outcomes

Graduate qualities

Outcome map

Responding to student feedback

Responding to student feedback

Disclaimer

On this page

Useful links

Media

Student links

About us

Connect