FBB3650 Animalcellsteknologi 7,5 hp

• Introduction to processes for the manufacturing of biopharmaceuticals. • Introduction to animal cell based cultivation process and relations/interactions between cultivation and other steps of the biopharmaceutical process.
• Usage of stable expression systems and description of the existing systems, e.g. cell lines.
• Review of cell metabolism relevant for the animal cell cultivation and application to process design. Scale-up aspects.
• Issues of commercial production, e.g. requirements of patient safety and compliance to regulatory constraints.
• Integration of the different course materials into development and design of a cultivation process.
• Cells as product
• Basic techniques for mammalian cell culture in shake flask, and small-scale fed-batch bioreactor operations

The students will learn how to design a cultivation process to produce a biopharmaceutical drug protein. In particular, after the course, they will be able to

• design a cultivation process flow sheet of operations
• select an appropriate cell line
• choose an expression system
• design a cultivation process fit for industrial purpose, i.e. integrating scale-up constraints, Good Manufacturing Practice (GMP), manufacturing operation
• select the level of safety required for the patients and design a process accordingly
• be able to design a strategy to develop a cultivation process

The KTH course
BB1120 Cultivation technology or
BB2080 Bioprocess Technology or equivalent.

När kurs inte längre ges har student möjlighet att examineras under ytterligare två läsår.

• DEL1 - Deltagande, 2,5 hp, betygsskala: P, F
• PRO1 - Projekt, 5,0 hp, betygsskala: P, F

Examinator beslutar, baserat på rekommendation från KTH:s handläggare av stöd till studenter med funktionsnedsättning, om eventuell anpassad examination för studenter med dokumenterad, varaktig funktionsnedsättning.

Examinator får medge annan examinationsform vid omexamination av enstaka studenter.

(1) > 50 % attendance at lectures, and
(2) Score > 60 % of max points at written examination, and
(3) > 80 % of home assignments approved

Antonius Van Maris

• Vid grupparbete har alla i gruppen ansvar för gruppens arbete.
• Vid examination ska varje student ärligt redovisa hjälp som erhållits och källor som använts.
• Vid muntlig examination ska varje student kunna redogöra för hela uppgiften och hela lösningen.