The Cell Technology Group (CETEG), Div. Bioprocess, School of Biotechnology, KTH, is a research laboratory for cell technology and in particular for mammalian and human cell cultivation bioprocess.
CETEG offers a service of development of animal cell based processes suitable for industrial production of biopharmaceutical (e.g. antibody, glycoprotein) in CHO or NS0 cell-based system in preparation for clinical phase I manufacturing. A service of glycoprotein production is also provided at scale up to 20 L bioreactor, for the manufacturing of material for toxicological tests or as tool/support for research. Finally consulting for development or manufacturing of biopharmaceuticals is offered as well.
- Extensive experience of process development for biopharmaceutical industry, e.g. CHO, NS0, HEK293
- Development of fed-batch or perfusion process process suitable for commercial production
- Process transfer to Contract Manufacturing Organization (CMO) for GMP production, including support to pilot/commercial size
- Full GLP documentation and traceability
- Consulting for biopharmaceutical process development and production
- Production of material in view of toxicological study up to 20 L size
- Production of material by transient expression system, e.g. HEK293, insect cells
- Production of cells for research
Assurance of quality
Due to a long experience of biopharmaceutical industry in the team, work according to GLP is provided when necessary.
The CETEG laboratory is equipped with instrumentation suitable for animal cell culture in small scale and bioreactor scale up to 20 L. The animal cell lab has HEPA filtered atmosphere. GLP is applied when required with usage of laboratory books, complete traceability and complete documentation.
Since the initiation of this service facility in 2008, numerous services have been delivered by the CETEG, among others: Three fed-batch processes were developed for the production of biopharmaceutical, i.e. monoclonal antibody and glycoproteins. Material was manufactured for toxicological study in 4 L and 20 L sizes for two processes. Processes were successfully transferred to CMO for GMP production in view of manufacturing of clinical material.
The CETEG laboratory is equipped with instrumentation suitable for animal cell culture in small scale and bioreactor scale up to 20 L.
- 3 bioreactors of 4 L (or 2 L)
- Bioreactor of 20 L (collaboration with Belach)
- Alternating Tangential Flow filtration for perfusion or medium renewal
- NovaBioprofile FLEX: cell count, cell viability, concentrations of glucose, glutamine, lactate, ammonia, pH, pCO2, osmolarity
- 4 Laminar flow hoods
- 4 CO2 incubators
- Laboratories with HEPA filtered air
Several analytical methods are available as support for the cell cultivation activity or as stand-alone.
- IgG analysis by protein A HPLC
- Free amino acid analysis by HPLC
- Determination of protein amino acid composition by HPLC
- Flow cytometry
Purification is performed in collaboration with Bioproduction Center, School of Biotechnology, KTH.
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