Bioproduction Resources

Bioproduction Resources

Data

Example clonal expression data

Our latest product data sheet is available for download, it contains expression data from a variety of evaluations that used GS selection as part of the CHO SOURCE GS null CHO K1 expression system to generate recombinant proteins.

Alternatively, see our technical information:

Product Sheet Technical Data

Safety

Molecular validation of knockout

As the final product will be administered to patients, the manufacture of biotherapeutic products is a highly regulated process. As a core part of the manufacturing process, the CHO cell host must be well characterised and safe for the manufacture of biotherapeutics.

When considering which cell line to use for the manufacture of biotherapeutics, the safety profile of the cell line is a core concern. To address these concerns review our traceability information which includes reference to the following:

  • Origins and acquisition of the CHO K1 cell line
  • Engineering of the adherent cells
  • Genomic and functional characterisation of Glutamine Synthetase knockout

Cell Line Derivation

During full evaluation of the cell line we can also make available a more extensive traceability pack that includes:

  • Adaptation to suspension growth in animal component free, chemically defined media
  • cGMP banking
  • adventitious agents testing in line with ICH Q5
  • Replication competent AAV testing

To raise the bar in expected safety standards, we are the only provider of commercially available CHO cells to have published the whole genome sequence of our cells. Eagle Genomics were commissioned to perform the high quality genome assembly and gold standard gene annotation.

Download the our annotated whole genome sequence data :

GS Knockout CHO K1 Sequence

Download a copy of the document we sent to the MHRA prior to a meeting requesting Scientific Advice. This document includes:

  • Background information on the engineering and derivation of the cell line
  • The questions we put to the MHRA regarding their opinions on our culturing, engineering and traceability of the cell line
  • The responses the MHRA gave to these questions

MHRA Scientific Advice

Whitepapers

Download our whitepaper on the role genome engineering has to play in the future of bioprocessing and biomanufacturing. This whitepaper discusses:

  • How to improve the expression capacity of biomanufacturing during cell line development of CHO cells
  • The different genome engineering methods available to modify CHO cells for improved recombinant protein expression
  • How improved manufacturing can drive personalized medicine
  • The importance of metabolic selection systems such as DHFR or Glutamine Synthetase

Maximising The Potential of Biomanufacturing Cell Lines

Read our tutorial that was published in GEN on how genome engineering has been used to remove host cell proteins that were co-purifying with a recombinant protein product and could not easily be removed through downstream processing approaches.

Engineering Biotherapeutic Quality

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