F3A5202 Animalcellteknologi 6,0 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

·       Handout material

·       Butler M ed. (2007) “Cell Culture and Upstream Processing” Taylor and Francis ISBN 0-415-39969-6

Ozturk S and Hu W-S (2006) “Cell Culture Technology for Pharmaceutical and Cell-based Therapies” Taylor and Francis ISBN 0-8247-5334-8

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

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.

Course requirements:

(1) > 50 % attendance at lectures,and

(2) Score > 60 % of max points at written examination,and

(3) > 80 % of home assignments approved

Gen Larsson

• 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.