Animal Cell Pilot Plant - Process Development

The Animal Cell Pilot Plant Facility team specializes in the scale-up of processes using animal cell lines adapted for culture in suspension (insect, mammalian and human). To date, successful process scale-up with several cell lines (Sf-9, CHO, HEK293, Jurkat, etc) and using several expression systems such as stable cell lines, transient transfection and viral infection (baculovirus, adenovirus) have been achieved. Service requestors are expected to already have an expression system developed in shaker or spinner flasks (suspension).

Process development, optimization and scale-up
The first step is to gather available information about the process, the expression levels of bioactive material already achieved, the required amount of material to be produced and the expected quality of the material to be delivered. Based on this information, the required production scale can be determined, which then allows to propose a process scale-up scheme. Such scheme may include different process optimization options (medium screening and optimization, small-scale fed-batch vs perfusion assessment) to improve specific or volumetric productivity of the expression system prior to process scale-up.

Generally, once the process is considered optimized at small scale, it is transferred in bioreactor at bench-scale for further optimization of the expression level through better controlled environmental conditions and development of feeding strategies. Once the bioreactor cultivation process is well optimized and characterized at bench-scale, it is scaled-up anywhere between 20-L and 100-L, based on the targeted amount of material.

Production without process development
The Animal Cell Pilot Plant Facility team can also provide services to companies that already have a fully developed process but are lacking production capacity. In such case, the production scheme proposal is normally based on the operating procedures (DOPs or SOPs) of the existing process.

Options

Training
The Facility can provide, on an individual charge basis, hands-on training to laboratory personnel regarding the operation of bioreactor systems for animal cell culture. Training is available for batch, fed-batch or perfusion culture operation.

Complementary work

Development and optimization of expression systems
Experts from the Insect Cell Technology or Mammalian Cell Technology teams can support development and optimization of expression systems (please view the Bioprocess section of this Web site fro more details).

Downstream Processing
The Downstream Processing team can support the development and scale-up of a purification process associated with the desired bioproduct.