Bioprocess Analytical Technologies, 6 credits

Bioprocessanalytiska tekniker, 6 hp

TFTB50

Main field of study

Engineering Biology

Course level

Second cycle

Course type

Programme course

Director of studies or equivalent

Magnus Boman

Education components

Preliminary scheduled hours: 56 h
Recommended self-study hours: 104 h

Available for exchange students

Yes
ECV = Elective / Compulsory / Voluntary
Course offered for Semester Period Timetable module Language Campus ECV
6CKEB Chemical Biology, Master of Science in Engineering (Industrial Bioprocesses) 7 (Autumn 2023) 1, 2 4, 4 Swedish/English Linköping C
6CTBI Engineering Biology, Master of Science in Engineering (Industrial Bioprocesses) 7 (Autumn 2023) 1, 2 4, 4 Swedish/English Linköping C

Main field of study

Engineering Biology

Course level

Second cycle

Advancement level

A1X

Course offered for

  • Master of Science in Engineering Biology
  • Master of Science in Chemical Biology

Prerequisites

Prior knowledge and laboratory skills in engineering and physics, chemistry/biochemistry, cell biology and mathematics from the first three years of the TB and KB programmes, or equivalent.

Intended learning outcomes

The course will give an introduction to the bioanalytical techniques and sensors used in biomanufacturing industry and during process development as well as how they are used for product quality control, analysis of metabolites, nutrients, bioproducts and product variants, and for monitoring of process parameters, optimization and control of bioprocesses. The course will also give the students a good understanding on how bioanalytical techniques and sensors can be used for measuring different relevant quality parameters and quality attributes and how this information ca be used for implementation of Quality-by-Design in production of biotechnological products and to facilitate more sustainable production. After the course, the students should be able to:

  • Account for common bioanalytical methods, technologies, and sensors that are used in the bioprocess industry and the chemical, biochemical, and/or physical principles upon which they are based.
  • Describe which bioanalytical technologies that are relevant to apply to address relevant questions that may arise during biotechnological production and process development.   
  • Account for the concept Quality-By-Design (QbD) and how process analytical technologies (PAT) enable QbD in the bioprocess industry.
  • Analyze, reflect upon and present experimental data from common bioanalytical techniques for analysis of samples from biotechnical processes.

Course content

The course covers various bioanalytical techniques and sensors that are used in biological production and during process development. Their chemical and physical principles are discussed, as well as how they are used to address different analytical questions related to quality control of products, raw materials, analysis of metabolites, nutrients, bioproducts, product variants and biomolecular interactions. Possibilities to use process analytical technologies (PAT) and real-time bioanalytical data for monitoring process parameters, process optimization and control are discussed as we all as possibilities to use PAT to improve sustainability of biological processes. In addition, the course covers the role of PAT for determining and monitoring different quality parameters and attributes and how this information can be used for implementation of Quality-by-Design concepts in bioproduction. Bioanalytical techniques that are discussed include mass spectroscopy, chromatography, biosensors, various chemical and physical sensors, immunological methods, and spectroscopy. The course also touches upon methods for data collection and data treatment, multidimensional data representation and data structures, and multivariate data analysis.

Teaching and working methods

The course is based on a combination of lectures, seminars, and laboratory exercises. A literature assignment is conducted in small groups and will cover a relevant topic on the subject of the course. The assignment is presented as a written report and is presented and discussed orally in a seminar. The laboratory exercises require active participation and are presented as written lab reports that will be discussed in a seminar.

Examination

LAB1Laboratory work1.5 creditsU, G
UPG1Project1.5 creditsU, G
TEN1Written examination3 creditsU, 3, 4, 5

Grades for examination modules are decided in accordance with the assessment criteria presented at the start of the course.

Grades

Four-grade scale, LiU, U, 3, 4, 5

Other information

About teaching and examination language

The teaching language is presented in the Overview tab for each course. The examination language relates to the teaching language as follows: 

  • If teaching language is “Swedish”, the course as a whole could be given in Swedish, or partly in English. Examination language is Swedish, but parts of the examination can be in English.
  • If teaching language is “English”, the course as a whole is taught in English. Examination language is English.
  • If teaching language is “Swedish/English”, the course as a whole will be taught in English if students without prior knowledge of the Swedish language participate. Examination language is Swedish or English depending on teaching language.

Other

The course is conducted in a manner where both men's and women's experience and knowledge are made visible and developed. 

The planning and implementation of a course should correspond to the course syllabus. The course evaluation should therefore be conducted with the course syllabus as a starting point. 

The course is campus-based at the location specified for the course, unless otherwise stated under “Teaching and working methods”. Please note, in a campus-based course occasional remote sessions could be included.  

If special circumstances prevail, the vice-chancellor may in a special decision specify the preconditions for temporary deviations from this course syllabus, and delegate the right to take such decisions.

Department

Institutionen för fysik, kemi och biologi

Course literature

Books

  • Jagschies, Günter, Lindskog, Eva, Ła̧cki, Karol, Galliher, Parrish, (2018) Biopharmaceutical processing : development, design, and implementation of manufacturing processes. Amsterdam, Netherlands : Elsevier, [2018]
    ISBN: 9780128125526, 0128125527, 9780081006238
  • Mikkelsen, Susan R., Cortón, Eduardo, (2016) Bioanalytical chemistry. Second edition. Hoboken, New Jersey : John Wiley & Sons, Incorporated, [2016]
    ISBN: 9781118302545, 9781119057635

Other

  • Scientific articles and documents/guidelines from regulatory authorities and organizations.

Code Name Scope Grading scale
LAB1 Laboratory work 1.5 credits U, G
UPG1 Project 1.5 credits U, G
TEN1 Written examination 3 credits U, 3, 4, 5

Grades for examination modules are decided in accordance with the assessment criteria presented at the start of the course.

Course syllabus

A syllabus must be established for each course. The syllabus specifies the aim and contents of the course, and the prior knowledge that a student must have in order to be able to benefit from the course.

Timetabling

Courses are timetabled after a decision has been made for this course concerning its assignment to a timetable module. 

Interruption in and deregistration from a course

The LiU decision, Guidelines concerning confirmation of participation in education (Dnr LiU-2020-02256), states that interruptions in study are to be recorded in Ladok. Thus, all students who do not participate in a course for which they have registered must record the interruption, such that the registration on the course can be removed. Deregistration from or interrupting a course is carried out using a web-based form: https://www.lith.liu.se/for-studenter/kurskomplettering?l=en

Cancelled courses and changes to the course syllabus

Courses with few participants (fewer than 10) may be cancelled or organised in a manner that differs from that stated in the course syllabus. The Dean is to deliberate and decide whether a course is to be cancelled or changed from the course syllabus. 

Guidelines relating to examinations and examiners 

For details, see Guidelines for education and examination for first-cycle and second-cycle education at Linköping University, Dnr LiU-2020-04501  (http://styrdokument.liu.se/Regelsamling/VisaBeslut/917592).

An examiner must be employed as a teacher at LiU according to the LiU Regulations for Appointments, Dnr LiU-2021-01204 (https://styrdokument.liu.se/Regelsamling/VisaBeslut/622784). For courses in second-cycle, the following teachers can be appointed as examiner: Professor (including Adjunct and Visiting Professor), Associate Professor (including Adjunct), Senior Lecturer (including Adjunct and Visiting Senior Lecturer), Research Fellow, or Postdoc. For courses in first-cycle, Assistant Lecturer (including Adjunct and Visiting Assistant Lecturer) can also be appointed as examiner in addition to those listed for second-cycle courses. In exceptional cases, a Part-time Lecturer can also be appointed as an examiner at both first- and second cycle, see Delegation of authority for the Board of Faculty of Science and Engineering.

Forms of examination

Principles for examination

Written and oral examinations and digital and computer-based examinations are held at least three times a year: once immediately after the end of the course, once in August, and once (usually) in one of the re-examination periods. Examinations held at other times are to follow a decision of the faculty programme board.

Principles for examination scheduling for courses that follow the study periods:

  • courses given in VT1 are examined for the first time in March, with re-examination in June and August
  • courses given in VT2 are examined for the first time in May, with re-examination in August and January
  • courses given in HT1 are examined for the first time in October, with re-examination in January and August
  • courses given in HT2 are examined for the first time in January, with re-examination in March and in August.

The examination schedule is based on the structure of timetable modules, but there may be deviations from this, mainly in the case of courses that are studied and examined for several programmes and in lower grades (i.e. 1 and 2). 

Examinations for courses that the faculty programme board has decided are to be held in alternate years are held three times during the school year in which the course is given according to the principles stated above.

Examinations for courses that are cancelled or rescheduled such that they are not given in one or several years are held three times during the year that immediately follows the course, with examination scheduling that corresponds to the scheduling that was in force before the course was cancelled or rescheduled.

When a course, or a written examination (TEN, DIT, DAT), is given for the last time, the regular examination and two re-examinations will be offered. Thereafter, examinations are phased out by offering three examinations during the following academic year at the same times as the examinations in any substitute course. If there is no substitute course, three examinations will be offered during re-examination periods during the following academic year. Other examination times are decided by the faculty programme board. In all cases above, the examination is also offered one more time during the academic year after the following, unless the faculty programme board decides otherwise. In total, 6 re-examinations are offered, of which 2 are regular re-examinations. In the examination registration system, the examinations given for the penultimate time and the last time are denoted. 

If a course is given during several periods of the year (for programmes, or on different occasions for different programmes) the faculty programme board or boards determine together the scheduling and frequency of re-examination occasions.

Retakes of other forms of examination

Regulations concerning retakes of other forms of examination than written examinations and digital and computer-based examinations are given in the LiU guidelines for examinations and examiners, http://styrdokument.liu.se/Regelsamling/VisaBeslut/917592.

Course closure

For Decision on Routines for Administration of the Discontinuation of Educational Programs, Freestanding Courses and Courses in Programs, see DNR LiU-2021-04782. After a decision on closure and after the end of the discontinuation period, the students are referred to a replacement course (or similar) according to information in the course syllabus or programme syllabus. If a student has passed some part/parts of a closed program course but not all, and there is an at least partially replacing course, an assessment of crediting can be made. Any crediting of course components is made by the examiner.

Registration for examination

In order to take an written, digital or computer-based examination, registration in advance is mandatory, see decision in the university’s rule book https://styrdokument.liu.se/Regelsamling/VisaBeslut/622682. An unregistered student can thus not be offered a place. The registration is done at the Student Portal or in the LiU-app during the registration period. The registration period opens 30 days before the date of the examination and closes 10 days before the date of the examination. Candidates are informed of the location of the examination by email, four days in advance. 

Code of conduct for students during examinations

Details are given in a decision in the university’s rule book: http://styrdokument.liu.se/Regelsamling/VisaBeslut/622682.

Retakes for higher grade

Students at the Institute of Technology at LiU have the right to retake written examinations and digital and computer-based examinations in an attempt to achieve a higher grade. This is valid for all examination components with code “TEN”, “DIT” and "DAT". The same right may not be exercised for other examination components, unless otherwise specified in the course syllabus.

A retake is not possible on courses that are included in an issued degree diploma. 

Grades

The grades that are preferably to be used are Fail (U), Pass (3), Pass not without distinction (4) and Pass with distinction (5). 

  • Grades U, 3, 4, 5 are to be awarded for courses that have written or digital examinations.
  • Grades Fail (U) and Pass (G) may be awarded for courses with a large degree of practical components such as laboratory work, project work and group work.
  • Grades Fail (U) and Pass (G) are to be used for degree projects and other independent work.

Examination components

The following examination components and associated module codes are used at the Faculty of Science and Engineering:

  • Grades U, 3, 4, 5 are to be awarded for written examinations (TEN) and digital examinations (DIT).
  • Examination components for which the grades Fail (U) and Pass (G) may be awarded are laboratory work (LAB), project work (PRA), preparatory written examination (KTR), digital preparatory written examination (DIK), oral examination (MUN), computer-based examination (DAT), home assignment (HEM), and assignment (UPG).
  • Students receive grades either Fail (U) or Pass (G) for other examination components in which the examination criteria are satisfied principally through active attendance such as tutorial group (BAS) or examination item (MOM).
  • Grades Fail (U) and Pass (G) are to be used for the examination components Opposition (OPPO) and Attendance at thesis presentation (AUSK) (i.e. part of the degree project).

In general, the following applies:

  • Mandatory course components must be scored and given a module code.
  • Examination components that are not scored, cannot be mandatory. Hence, it is voluntary to participate in these examinations, and the voluntariness must be clearly stated. Additionally, if there are any associated conditions to the examination component, these must be clearly stated as well.
  • For courses with more than one examination component with grades U,3,4,5, it shall be clearly stated how the final grade is weighted.

For mandatory components, the following applies (in accordance with the LiU Guidelines for education and examination for first-cycle and second-cycle education at Linköping University, http://styrdokument.liu.se/Regelsamling/VisaBeslut/917592): 

  • If special circumstances prevail, and if it is possible with consideration of the nature of the compulsory component, the examiner may decide to replace the compulsory component with another equivalent component.

For possibilities to alternative forms of examinations, the following applies (in accordance with the LiU Guidelines for education and examination for first-cycle and second-cycle education at Linköping University, http://styrdokument.liu.se/Regelsamling/VisaBeslut/917592): 

  • If the LiU coordinator for students with disabilities has granted a student the right to an adapted examination for a written examination in an examination hall, the student has the right to it.
  • If the coordinator has recommended for the student an adapted examination or alternative form of examination, the examiner may grant this if the examiner assesses that it is possible, based on consideration of the course objectives.
  • An examiner may also decide that an adapted examination or alternative form of examination if the examiner assessed that special circumstances prevail, and the examiner assesses that it is possible while maintaing the objectives of the course.

Reporting of examination results

The examination results for a student are reported at the relevant department.

Plagiarism

For examinations that involve the writing of reports, in cases in which it can be assumed that the student has had access to other sources (such as during project work, writing essays, etc.), the material submitted must be prepared in accordance with principles for acceptable practice when referring to sources (references or quotations for which the source is specified) when the text, images, ideas, data, etc. of other people are used. It is also to be made clear whether the author has reused his or her own text, images, ideas, data, etc. from previous examinations, such as degree projects, project reports, etc. (this is sometimes known as “self-plagiarism”).

A failure to specify such sources may be regarded as attempted deception during examination.

Attempts to cheat

In the event of a suspected attempt by a student to cheat during an examination, or when study performance is to be assessed as specified in Chapter 10 of the Higher Education Ordinance, the examiner is to report this to the disciplinary board of the university. Possible consequences for the student are suspension from study and a formal warning. More information is available at https://www.student.liu.se/studenttjanster/lagar-regler-rattigheter?l=en.

Regulations (apply to LiU in its entirety)

The university is a government agency whose operations are regulated by legislation and ordinances, which include the Higher Education Act and the Higher Education Ordinance. In addition to legislation and ordinances, operations are subject to several policy documents. The Linköping University rule book collects currently valid decisions of a regulatory nature taken by the university board, the vice-chancellor and faculty/department boards.

LiU’s rule book for education at first-cycle and second-cycle levels is available at http://styrdokument.liu.se/Regelsamling/Innehall/Utbildning_pa_grund-_och_avancerad_niva

Books

Jagschies, Günter, Lindskog, Eva, Ła̧cki, Karol, Galliher, Parrish, (2018) Biopharmaceutical processing : development, design, and implementation of manufacturing processes. Amsterdam, Netherlands : Elsevier, [2018]

ISBN: 9780128125526, 0128125527, 9780081006238

Mikkelsen, Susan R., Cortón, Eduardo, (2016) Bioanalytical chemistry. Second edition. Hoboken, New Jersey : John Wiley & Sons, Incorporated, [2016]

ISBN: 9781118302545, 9781119057635

Other

Scientific articles and documents/guidelines from regulatory authorities and organizations.

Note: The course matrix might contain more information in Swedish.

I = Introduce, U = Teach, A = Utilize
I U A Modules Comment
1. DISCIPLINARY KNOWLEDGE AND REASONING
1.1 Knowledge of underlying mathematics and science (G1X level)
X
Physics, chemistry, biochemistry and cell biology
1.2 Fundamental engineering knowledge (G1X level)
X
Measurement technology, optics, control theory and electronics
1.3 Further knowledge, methods, and tools in one or several subjects in engineering or natural science (G2X level)
X
UPG1
TEN1
Methods and terminology for analytical measurement and data analysis 
1.4 Advanced knowledge, methods, and tools in one or several subjects in engineering or natural sciences (A1X level)
X
LAB1
UPG1
TEN1
Complex bioanalytical technologies and methods, PAT and QbD
1.5 Insight into current research and development work
X
UPG1
TEN1
Insight into central research questions in the field and industrial needs
2. PERSONAL AND PROFESSIONAL SKILLS AND ATTRIBUTES
2.1 Analytical reasoning and problem solving
X
UPG1
TEN1
Analysis of connection between need for certain information and choice of analytical methods 
2.2 Experimentation, investigation, and knowledge discovery
X
LAB1
UPG1
Labs and group assignment using problem-based learning
2.3 System thinking
X
TEN1
Connection between unit operations, PAT and QbD
2.4 Attitudes, thought, and learning
X

                            
2.5 Ethics, equity, and other responsibilities
X
TEN1
Regulatory and economical aspects, sustainability in bioproduction
3. INTERPERSONAL SKILLS: TEAMWORK AND COMMUNICATION
3.1 Teamwork
X
LAB1
UPG1
Labs and group assignment
3.2 Communications
X
LAB1
UPG1
Written assignments and lab reports, and oral presentation
3.3 Communication in foreign languages
X
LAB1
UPG1
Written assignments and lab reports, and oral presentation in English
4. CONCEIVING, DESIGNING, IMPLEMENTING AND OPERATING SYSTEMS IN THE ENTERPRISE, SOCIETAL AND ENVIRONMENTAL CONTEXT
4.1 External, societal, and environmental context
X
Discussion on possibilities to used PAT for increasing efficiency in bioproduction and increase product quality, reduce costs, and need for raw materials and energy.
4.2 Enterprise and business context
X
UPG1
TEN1
Focus on industrial applications
4.3 Conceiving, system engineering and management
X
TEN1
Concrete industrial needs and examples based on actual analytical problems
4.4 Designing
X
Guest lecture from industry
4.5 Implementing
X
Industry relevant aspects related to development and commercialization of sensor systems for bioproduction
4.6 Operating
X
LAB1
Laboratory exercises
5. PLANNING, EXECUTION AND PRESENTATION OF RESEARCH DEVELOPMENT PROJECTS WITH RESPECT TO SCIENTIFIC AND SOCIETAL NEEDS AND REQUIREMENTS
5.1 Societal conditions, including economic, social, and ecological aspects of sustainable development for knowledge development

                            
5.2 Economic conditions for knowledge development

                            
5.3 Identification of needs, structuring and planning of research or development projects
X

                            
5.4 Execution of research or development projects
X
UPG1
Analysis of data from labs and discussion about scientific articles
5.5 Presentation and evaluation of research or development projects
X
UPG1
Analysis of data from labs and discussion about scientific articles

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