96135 Biotech Manufacturing
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Subject handbook information prior to 2025 is available in the Archives.
Credit points: 6 cp
Result type: Grade and marks
Requisite(s): 96057 GMP for Manufacturing Operations AND 96134 Validation Principles and Practices AND 96059 International GMPs and Quality Assurance AND 96060 Good (Quality Control) Laboratory Practices AND 96069 Contamination Control AND 96062 Good Aseptic Practices and Sterile Products AND 96063 GxP and Quality Auditing Practices AND 96064 Risk Management for Pharmaceutical Operations
There are course requisites for this subject. See access conditions.
Description
Biotech manufacturing is one of the fastest growing technologies, driven by the pursuit of pharmaceutical companies to look for new and novel approaches to fight disease states, many of which have no known treatments or cures. Biotech manufacturing differs from traditional pharmaceutical manufacturing in the following ways:
- The end products are large molecules and manufactured in small batch sizes, as opposed to small molecule large batch size
- The use of recombinant technology versus traditional chemical synthesis of APIs.
- There is an upstream (cell fermentation) stage followed by a downstream (cell harvest and purification) stage
- Manufacturing equipment is often a combination of single-use, made from polymers, and multiple use stainless steel vessels and pipework, as opposed to stainless steel only.
- There is a need to select and characterise an appropriate Master Cell Bank (MCB) and Working Cell Bank (WCB) as the starting material
- There is a need to apply biological analytical methods
- Lyophilisation and aseptic filling versus terminal sterilization
Knowledge and understanding of these manufacturing operations is critical for students to have a well-rounded education in the area of therapeutic formulation and manufacturing. This subject addresses all of the seven points unique to biotech manufacturing, described in the bullet points above.
Many students will be working in Pharmaceutical Companies. This will allow students to view important activities routinely carried out in cleanroom environments. The activities are:
- Gowning and de-gowning using cleanroom garments
- Reading and recording pressure differentials between each cleanroom
- Environmental monitoring (including particle counting) of the cleanroom environment
- Sampling of the WFI and/or Purified Water
For those students who are not currently working in the industry, this course will access videos, literature and other media to provide this knowledge.
Subject learning objectives (SLOs)
| 109. | Demonstrate awareness and understanding of how to gown and de-gown in a cleanroom environment |
|---|---|
| 110. | Evaluate and assess the appropriateness and accuracy of pressure differentials between each cleanroom |
| 111. | Devise an appropriate environmental sampling plan for an authentic cleanroom |
| 112. | Devise an appropriate sampling procedure for a WFI or Purified Water system |
| 113. | Understand the fundamental differences between traditional pharmaceutical manufacturing and biotech manufacturing |
| 114. | Develop an understanding of cell culture/fermentation processes |
| 115. | Demonstrate awareness and understanding of upstream and downstream biotech manufacturing |
| 116. | Understand the importance of aseptic processing in cell culture/fermentation processes |
| 117. | Evaluate the appropriateness of single-use technology versus traditional multiuse technology from a quality and cost perspective |
| 118. | Demonstrate awareness and understanding of selection and characterisation of appropriate MCBs and WCBs as starting materials |
| 119. | Demonstrate awareness and understanding of biological analytical methods |
| 120. | Evaluate pharmaceutical regulations, standards and guidelines in multiple regulatory environments |
| 121. | Understand advantages and disadvantages of different host systems and transgenic models |
Course intended learning outcomes (CILOs)
The learning outcomes for this subject are as follows:
- Reflect on the knowledge, skills and attributes required for the evaluation and integration of emerging evidence into practice, promoting the growth of personal and professional learning, and the education of others. (01.09)
- Demonstrate accurate and comprehensive knowledge of risk management practices and models, and implement and evaluate them in a range of contexts. (02.01)
- Test, audit and validate pharmaceuticals manufacturing and distribution processes using appropriate methodologies. (02.02)
- Design, implement and evaluate control systems for pharmaceuticals manufacturing. (02.03)
- Demonstrate ethically and legally accountable approaches to pharmaceuticals manufacturing and control. (02.04)
- Analyse and synthesise knowledge of relevant concepts and theory, and apply skills of scientific research and reasoning to support Good Manufacturing Practice. (02.05)
- Produce accurate technical documentation, and communicate effectively and accurately with clients and stakeholders in written or spoken language appropriate to their needs. (02.06)
- Contribute as leader and collaborator in the assurance of Good Manufacturing Practice. (02.08)
- Collaborate effectively with other professions to ensure Good Manufacturing Practice. (02.10)
- Demonstrate knowledge of Good Manufacturing Practice in local, national and global contexts. (03.11)
Contribution to the development of graduate attributes
The topic Biotech Manufacturing has been selected because it is a fast-growing area in the pharmaceutical manufacturing field. Soon, it will be one of the most prevalent manufacturing processes. In addition, there is the opportunity to utilise the UTS GMP-lite facility for an authentic experience, enhancing student knowledge and understanding.
Lifelong learning:
Graduates of the Master of GMP are lifelong learners, committed to and capable of reflection and inquiry in their quest for personal development and excellence in professional practice.
Professional capacity:
Graduates of the Master of GMP are industry-focused, ethical practitioners with the understanding and proficiency to be leaders in their profession, capable of effectively analysing and implementing solutions in a global context.
Global Citizenship:
Graduates of the Master of Good Manufacturing Practice contribute to society, resolving to undertake those actions and responsibilities that will enhance their role in local, national and global communities.
Teaching and learning strategies
On campus (standard) mode: This subject will be delivered on the City campus and requires attendance for three hours of face-to-face contact per week, as well as approximately 1-3 hours of personal study pre-work before each class. However, should restrictions related to COVID-19 require it, classes for this subject will be conducted online. The format and content of online classes (should they be required) will be equivalent to face to face on-campus classes and the same attendance requirements apply.
Online (distance) mode: This subject is delivered online via Canvas. Students are required to contribute to weekly discussions as well as participate in occasional online meetings via zoom when required. Students should dedicate approximately 3-6 hours of time to this subject per week.
Students will learn in this Subject through online content comprising videos, set reading, directed research, activities online discussions and self-check quizzes. This independent learning will be supported by group learning experiences, in which ideas and concepts can be tested and refined
Strategy 1: Student directed learning: Students read articles and use online resources, such as online course material, videos, directed research, activities, self-check quizzes and case studies, provided via Canvas. This learning prepares students for their participation in activities that may include facilitated discussion of fundamental concepts drawn from course materials and solutions to industry case studies, assessable quizzes or activities as well as collaborative and interactive learning experiences.
Strategy 2: Collaborative and interactive learning experiences: Provide the students with the opportunity to engage with Peers and Academics to discuss and clarify concepts for a deeper understanding of online course materials.
- On campus students - engage in a weekly 3 hour workshop. Each workshop aims to apply online course materials to real life pharmaceutical industry scenarios through discussions and problem solving in collaboration with fellow students.
- Online students – engage in weekly discussion forums. Each online discussion aims to apply course material in real life pharmaceutical industry scenarios and collaboration with fellow students is required by posting and responding to other students posts in the discussion forum. Students participate in the online discussions by writing their comments in the Canvas platform in their own time and also read and respond to posts from peers. Each discussion has an end time designated by which students must have contributed.
Strategy 3: Early and consistent feedback: Early feedback is provided prior to the census date.
- On campus students – receive feedback in workshops or via the Canvas platform for activities. Feedback regarding the quizzes is provided following each quiz, via provision of answers and/or in-class review. The collaborative learning approach utilised in class will enable ongoing feedback to be provided in class, as areas of learning need are identified through class discussions.
- Online students – receive feedback during ‘open office’ hours and discussion forums. Feedback regarding the self-check quizzes is provided via Canvas immediately upon submission of each quiz. The collaborative learning approach will enable ongoing feedback to be provided to students, via teacher responses to posts, as areas of learning need are identified through online discussions.
Strategy 4: Group work: students work in groups during collaborative and interactive experiences. Students will need to coordinate group work, fostering negotiation, team building and teamwork skills. Students will need to demonstrate the ability to respond respectfully and constructively to their peers, fostering communication, constructive criticism and respect for diverse ways of working.
Strategy 5: Students are encouraged to critically reflect on their learning throughout the subject to identify areas where they may improve their performance and develop lifelong learning skills.
Content (topics)
Cleanroom gowning for controlled environments
Cleanroom pressure differentials
Environmental monitoring
WFI/Purified Water sampling
Manufacturing Principles – Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products
Introduction to recombinant technology
MCB and WCB selection and characterisation
Upstream processing
Downstream harvest and purification
Formulation and packaging
Biologics Analytical Methods
Students will start learning about recombinant technology and cell line selection and characterisation as the starting material. With this fundamental understanding, this subject will elaborate on upstream and downstream manufacturing. Specifically, students will apply this process using single-use technology. Students will evaluate gowning and de-gowning in cleanrooms, as well as evaluating pressure differentials and why these are necessary to maintain. Students will develop an environmental monitoring plan for a prescribed cleanroom.
Assessment
Assessment task 1: On-going Graded Assessment
| Intent: | Throughout the semester you will have the opportunity to check your understanding of the course content via graded assessments through the Canvas platform. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120 and 121 This task is aligned with the following course learning outcomes: 01.09, 02.01, 02.02, 02.03, 02.04, 02.08 and 02.10 |
| Groupwork: | Individual |
| Weight: | 15% |
| Criteria: | Tasks are marked online or by the teacher according to the specific requirements of each task. The tasks are designed to allow assessment of the student’s ability to apply and evaluate the principles taught. |
Assessment task 2: Environmental Monitoring Plan
| Intent: | Environmental monitoring of cleanrooms is mandatory and an essential task in determining the level of particulate and microbial contamination in a cleanroom. The monitoring plan and results are often reviewed by regulatory inspectors. The ability to prepare a plan for facilities is critical to success of maintaining the cleanroom in an acceptable level of cleanliness. This assessment allows you to demonstrate your understanding of how environmental monitoring principles are applied in a case that represents an authentic pharmaceutical industry scenario. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 111 This task is aligned with the following course learning outcomes: 01.09, 02.01, 02.02, 02.05, 02.06, 02.10 and 03.11 |
| Type: | Project |
| Groupwork: | Individual |
| Weight: | 25% |
| Length: | 1500 words +/- 10% (excluding references) |
| Criteria: | Provided via Canvas |
Assessment task 3: Evaluate Single-Use vs Traditional Multi-Use Manufacturing Equipment
| Intent: | Biotech manufacturing is increasingly moving towards the use of single-use (polymer-based) manufacturing equipment as opposed to the traditional multi-use equipment. In making the decision to adopt single-use, manufacturers evaluate cost, impact to the environment, decrease in cleaning needs, impact on quality of the product. There are a number of manufacturers of single-use equipment and many different manufacturing applications. This assessment task allows you to evaluate an authentic manufacturing process that adopts single use and, to determine whether single-use is appropriate for the reasons outlined above. Students present their work to the class to demonstrate understanding of the subject matter in a pharmaceutical industry setting. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 113, 115, 116, 117, 119 and 120 This task is aligned with the following course learning outcomes: 01.09, 02.01, 02.02, 02.05, 02.06, 02.10 and 03.11 |
| Type: | Presentation |
| Groupwork: | Individual |
| Weight: | 30% |
| Length: | 15 minutes |
| Criteria: | Provided via Canvas |
Assessment task 4: Report
| Intent: | This assessment will give you an opportunity to demonstrate your ability to evaluate biotech manufacturing processes and technology, including aseptic processing. This is a key requirement for staff working in biotech manufacturing to be able to focus on the critical information and ensure both GMP compliance and efficient operations. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 113, 114, 117, 118, 119 and 120 This task is aligned with the following course learning outcomes: 01.09, 02.01, 02.02, 02.05, 02.06, 02.10 and 03.11 |
| Type: | Report |
| Groupwork: | Individual |
| Weight: | 30% |
| Length: | Approximately 1500 words |
| Criteria: | Provided via Canvas |
Minimum requirements
In order to pass this subject, students are required to attend a minimum of 85% of classes and submit all assessments. The pass mark for assessments is 50%.
Required texts
Coursework Assessments Procedures
Graduate School of Health Policy, Guidelines and Procedures (login required)
Additional required readings will be provided via Canvas
Recommended texts
The following material is mandatory for this subject. Additional reference material will be provided by the lecturer(s) throughout the session, which will be available on Blackboard.
PIC/S Guide to Good Manufacturing Practices Part 1
PIC/S Guide to Good Manufacturing Practices Annex 2 - Manufacture of Biological Medicinal Substances and Products for Human Use
TGA – Australian Regulatory Guidelines for Biologicals
TGA – TGOs 83-87
The following material will aid in the student’s understanding of this subject. Students are expected to have read them.
Relevant Codes of EMA and FDA 21CFR series: 211
Note: Documents marked with an asterisk are available free of charge from the internet.