BIOPRENG 2012 - Pharmaceutical Production Processes
North Terrace Campus - Semester 2 - 2024
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General Course Information
Course Details
Course Code BIOPRENG 2012 Course Pharmaceutical Production Processes Coordinating Unit Bioprocess Engineering Term Semester 2 Level Undergraduate Location/s North Terrace Campus Units 3 Contact Up to 4 hours per week Available for Study Abroad and Exchange Y Assumed Knowledge CHEM ENG 1007 Assessment Assignments, final examination Course Staff
Course Coordinator: Dr Luis Toronjo-Urquiza
Course coordinator: Luis Toronjo-Urquiza
E-mail: luis.toronjo-urquiza@adelaide.edu.au / a1227947@adelaide.edu.au
Office: Annex Building, Room A207
Consulting times: Monday 10:00-12:00 pm / Thursday 2:00-4:00 pm
UofA profile:Course Timetable
The full timetable of all activities for this course can be accessed from .
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Learning Outcomes
Course Learning Outcomes
On successful completion of this course, students will be able to:
1 Recognise the role of key operational units in pharmaceuticals manufacturing processes 2 Explain the fundamental concepts of upstream and downstream processes in API production 3 Apply the mathematical principles of cell culture kinetics fermentation 4 Apply the principles of operation of batch, fed-batch and continuous bioreactor regimes 5 Explain the principles of sterilization in setting-up culture and design of processes to avoid contamination risk 6 Apply the fundamental principles for product recovery 7 Apply the fundamental principles for filtration 8 Apply the fundamental principles for primary isolation in product purification 9 Apply the principles of advanced product purification by different liquid chromatography techniques 10 Apply the principles of formulation to the needs of the product 11 Emphasize unique requirements of modern complex pharmaceutical products 12 Describe and sketch common bioseparation methods, equipment and integrated processes.
The above course learning outcomes are aligned with the Engineers Australia
The course is designed to develop the following Elements of Competency:
KNOWLEDGE AND SKILL BASE
- 1.1. Comprehensive, theory-based understanding of the underpinning natural and physical sciences and the engineering fundamentals applicable to the engineering discipline.
- 1.2. Conceptual understanding of the mathematics, numerical analysis, statistics, and computer and information sciences which underpin the engineering discipline.
- 1.5. Knowledge of engineering design practice and contextual factors impacting the engineering discipline.
- 1.6. Understanding of the scope, principles, norms, accountabilities and bounds of sustainable engineering practice in the specific discipline.
ENGINEERING APPLICATION ABILITY
- 2.1. Application of established engineering methods to complex engineering problem-solving.
- 2.2. Fluent application of engineering techniques, tools and resources.
- 2.3. Application of systematic engineering synthesis and design processes.
PROFESSIONAL AND PERSONAL ATTRIBUTES
- 3.1. Ethical conduct and professional accountability.
- 3.2. Effective oral and written communication in professional and lay domains.
- 3.3. Creative, innovative and pro-active demeanour.
- 3.4. Professional use and management of information.
- 3.5. Orderly management of self, and professional conduct.
- 3.6. Effective team membership and team leadership.University Graduate Attributes
This course will provide students with an opportunity to develop the Graduate Attribute(s) specified below:
University Graduate Attribute Course Learning Outcome(s) Attribute 1: Deep discipline knowledge and intellectual breadth
Graduates have comprehensive knowledge and understanding of their subject area, the ability to engage with different traditions of thought, and the ability to apply their knowledge in practice including in multi-disciplinary or multi-professional contexts.
1,2,5,11,12 Attribute 2: Creative and critical thinking, and problem solving
Graduates are effective problems-solvers, able to apply critical, creative and evidence-based thinking to conceive innovative responses to future challenges.
3-4, 6-10 Attribute 3: Teamwork and communication skills
Graduates convey ideas and information effectively to a range of audiences for a variety of purposes and contribute in a positive and collaborative manner to achieving common goals.
1-12 Attribute 4: Professionalism and leadership readiness
Graduates engage in professional behaviour and have the potential to be entrepreneurial and take leadership roles in their chosen occupations or careers and communities.
1-12 Attribute 5: Intercultural and ethical competency
Graduates are responsible and effective global citizens whose personal values and practices are consistent with their roles as responsible members of society.
1-12 Attribute 7: Digital capabilities
Graduates are well prepared for living, learning and working in a digital society.
1-12 Attribute 8: Self-awareness and emotional intelligence
Graduates are self-aware and reflective; they are flexible and resilient and have the capacity to accept and give constructive feedback; they act with integrity and take responsibility for their actions.
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Learning Resources
Required Resources
N/ARecommended Resources
This list of recommended books can help support the learning of the content taught in the course.
- Shuler M.L. & Kargi F. Bioprocess Engineering 2nd Edition (Prentice-Hall International);
- Pauline M. Doran, Bioprocess Engineering Principles (2nd Edition, 2003)
- Janson J.-C. and Ryden L., Protein Purification, principles, high resolution methods and applications. Wiley VCH, 1997, 2nd Edition
- Michael Levin, Pharmaceutical Process Scale-up, CRC Press, 2006.
Online Learning
A range of online resources will be provided via MyUni. -
Learning & Teaching Activities
Learning & Teaching Modes
The activities for this course are structured by week and include the following activities:
- Online Theory Lectures
To be viewed before the Workshop session
- Practice Workshops
Solve problems together in class and go through solutions.
- Tutorials
The student can book 1 on 1 appointments with the coordinator during consulting times.
- Demonstrations
The student has the possibility to attend guided tours of facilities where equipment processes and unit operations can be introduced.Workload
The information below is provided as a guide to assist students in engaging appropriately with the course requirements.
The information below is provided as a guide to assist students in engaging appropriately with the course requirements.
Activity Contact Hours Workload hours Expected total workload hours Online Lectures 0 30 30 Workshops 24 36 60 Tutorials 24 0 24 Demonstrations 6 0 6 Study 0 40 40 TOTAL 54 106 160
Learning Activities Summary
Topic 1: Introduction to pharmaceutical processing
Topic 2: Kinetics of cell cultures
Topic 3: Operation and bioreactor regimes
Topic 4: Techniques and unit operations for product recovery
Topic 5: Techniques and unit operations for filtration
Topic 6: Techniques and unit operations for primary isolation
Topic 7: Techniques and unit operations for high-resolution purification and polishing
Topic 8: Techniques and unit operations for formulation
Topic 9: Process integrationSpecific Course Requirements
N/A -
Assessment
The University's policy on Assessment for Coursework Programs is based on the following four principles:
- Assessment must encourage and reinforce learning.
- Assessment must enable robust and fair judgements about student performance.
- Assessment practices must be fair and equitable to students and give them the opportunity to demonstrate what they have learned.
- Assessment must maintain academic standards.
Assessment Summary
Assessment Task Weighting (%) Individual/ Group Formative/ Summative Learning outcomes Workshop and Tutorials 10 Individual Formative and Summative 1-12 In class Quizzes 30 Individual Formative and Summative 1-10 Project Presentation 20 Individual & Group Formative and Summative 1-12 Final examination 40 Individual Summative 1-12 Total 100
This assessment breakdown complies with the University's Assessment for Coursework Programs Policy.Assessment Related Requirements
N/AAssessment Detail
In this course, the following assessments will be completed:
Workshops and Tutorials (individual) (10%)
- Weekly problems submitted (MiUni) a day before the workshop
- Each weekly submission accounts for 1% o the final grade
- Submissions are not graded in the correct answer but in the effort put into the problems
- Coming to 1 on 1 tutorial with questions will also grant 0.5% per session
- The maximum amount of points that can be granted is 10% total
In-class Quizzes (individual) (30%)
- In weeks 5 and 10 quizzes will be conducted during the workshop session.
- Each quiz will account for 15% of the final grade
Project presentation (group/individual) (20%)
- In week 13, students will present a process design for a pharmaceutical product
- All members of the group will have allocated sections of the process
- All members will contribute during their oral presentation
- Tutorials are also available for groups to help with their project
Final Exam (individual) (40%) - undertaken during the exam period
- Final exam is mathematical and problem-solving based
- The problems will be similar to the ones used during workshops
Submission
All quizzes, tutorials and practical reports will be submitted via MyUni.Course Grading
Grades for your performance in this course will be awarded in accordance with the following scheme:
M10 (Coursework Mark Scheme) Grade Mark Description FNS Fail No Submission F 1-49 Fail P 50-64 Pass C 65-74 Credit D 75-84 Distinction HD 85-100 High Distinction CN Continuing NFE No Formal Examination RP Result Pending Further details of the grades/results can be obtained from Examinations.
Grade Descriptors are available which provide a general guide to the standard of work that is expected at each grade level. More information at Assessment for Coursework Programs.
Final results for this course will be made available through .
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Student Feedback
The University places a high priority on approaches to learning and teaching that enhance the student experience. Feedback is sought from students in a variety of ways including on-going engagement with staff, the use of online discussion boards and the use of Student Experience of Learning and Teaching (SELT) surveys as well as GOS surveys and Program reviews.
SELTs are an important source of information to inform individual teaching practice, decisions about teaching duties, and course and program curriculum design. They enable the University to assess how effectively its learning environments and teaching practices facilitate student engagement and learning outcomes. Under the current SELT Policy (http://www.adelaide.edu.au/policies/101/) course SELTs are mandated and must be conducted at the conclusion of each term/semester/trimester for every course offering. Feedback on issues raised through course SELT surveys is made available to enrolled students through various resources (e.g. MyUni). In addition aggregated course SELT data is available.
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Student Support
- Academic Integrity for Students
- Academic Support with Maths
- Academic Support with writing and study skills
- Careers Services
- Library Services for Students
- LinkedIn Learning
- Student Life Counselling Support - Personal counselling for issues affecting study
- Students with a Disability - Alternative academic arrangements
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Policies & Guidelines
This section contains links to relevant assessment-related policies and guidelines - all university policies.
- Academic Credit Arrangements Policy
- Academic Integrity Policy
- Academic Progress by Coursework Students Policy
- Assessment for Coursework Programs Policy
- Copyright Compliance Policy
- Coursework Academic Programs Policy
- Intellectual Property Policy
- IT Acceptable Use and Security Policy
- Modified Arrangements for Coursework Assessment Policy
- Reasonable Adjustments to Learning, Teaching & Assessment for Students with a Disability Policy
- Student Experience of Learning and Teaching Policy
- Student Grievance Resolution Process
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Fraud Awareness
Students are reminded that in order to maintain the academic integrity of all programs and courses, the university has a zero-tolerance approach to students offering money or significant value goods or services to any staff member who is involved in their teaching or assessment. Students offering lecturers or tutors or professional staff anything more than a small token of appreciation is totally unacceptable, in any circumstances. Staff members are obliged to report all such incidents to their supervisor/manager, who will refer them for action under the university's student鈥檚 disciplinary procedures.
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