Spring Intro 2023

06/03/2023

The cell culture process includes critical parameters that can vary the outcome of the manufacture

Bioreactor

Motor: RPM 2,4

Gases 4 : N 2 , O 2 , CO 2

Feed 2 Alkali 3

Probe outputs: temperature , pH, dissolved oxygen 2

Cell and growth media 2

N 2 = nitrogen; O 2 = oxygen; CO 2 = carbon dioxide; RPM = revolutions per minute. A mgen Inc. An Introduction to Biotechnology. www.amgen.com/pdfs/misc/An_Introduction_Biotechnology.pdf. Accessed February 10, 2012 . 2. Martin I, et al. Trends Biotech . 2004;22:80-86. 3. Langheinrich C, et al. Biotechnol Bioeng . 1999;66:171-179. 4. Rodrigues C, et al. Biotechnology Advances . 2011;29:815 829.

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Several purification steps are needed to remove impurities and product variants

Removing process impurities (trace DNA, host cell proteins, endotoxins) and product impurities

Intermediate Product

Final Product

v

v

Virus Filtration

Further Stages

Chromatography Concentration Diafiltration

[Adapted from presentation by G. Slaff, Amgen, Innovations in Biopharmaceutical Manufacturing – A Critical Step for Patients, at EAHP, Barcelona, March 26, 2009]

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