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Pre-Clinical Development of Monoclonal Antibodies and Generation of GMP-Ready Proteins

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Cell Line Generation

High expressing cell lines is a key factor for low cost manufacturing of recombinant proteins. Bioceros has extensive expertise in this field.

Bioceros has developed it’s own serum-free, suspension CHO platform, named CHOBC™.

Bioceros has generated in recent years many high expressing cell lines for various customers in both CHO and PER.C6® and has transferred cell lines successfully to GMP manufacturing facilities. Proteins that were expressed are blood derived proteins, fusion proteins and monoclonal antibodies.

Bioceros uses its technology platform to generate high protein producing mammalian (primarily CHO based) cell lines for customers and manufactures batches of the recombinant proteins at 20L scale. Typically such a program contains the following steps:

  1. Cloning of DNA sequences encoding the recombinant protein in Bioceros vectors
  2. Transfection of CHO cells and preparation of stable pools of high producing cells (all steps performed under serum-free conditions)
  3. Subcloning of the best producing cell lines (optional)
  4. Pre-clinical manufacturing of batches of recombinant proteins up to 20L scale in state-of-the art disposable bioreactors (optional)
  5. Each program is tailored to customers wishes; we are flexible in the design of our Cell Line Generation programs

This service, which typically takes three months to run steps one and two of the program, allows companies a quick start in pre-clinical and clinical product development with established CHO cell lines. Both the generation of protein producing cell lines as well as pre-clinical production of batches of recombinant protein are done under serum-free suspension conditions. All Clone Generation work is QA controlled and all reports describing the Cell Line generation work are QA audited and signed. The cell lines that are generated are ready for use in a GMP facility.

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