Recombinant Proteins - Mammalian

BION-CHO 6.0 System™

The Bioneer BION-CHO 6.0 System™ outperforms commercially available systems. By utilizing our proprietary vectors specifically designed for use in CHO-DG44 cells, we achieve a significant increase in expression levels, which can be further enhanced through MTX amplification and media optimization.

We have successfully demonstrated the expression of various protein modalities, including enzymes, monoclonal antibodies (mAbs), and Bispecifics, maintaining stable expression over 60 generations, even in cells subjected to MTX amplification. With demonstrated titers reaching up to 6 g/L for mAb expression, the BION-CHO 6.0 System™ is the premium choice for a system.

Workflow at Bioneer

Leveraging our expertise across diverse protein types, we provide early insights into the expression of your protein and mitigate risk through a flexible step-wise project approach with Go/No-Go decision points.

Process Step	Our approach	Time
Gene Design and Plasmid Preparation	Gene sequence is optimized for use in selected system Gene synthesis via 3rd party provider Cloning into expression vector Large scale, high purity plasmid preparation for transfection (Can be conducted as stand-alone service)	3 – 6 weeks
Transfection and Generation of Stable Pools	Transfection into cells via nucleofection Cells subjected to selection pressure Banking of cells from stable pools	3 weeks
Optional MTX Amplification	Additional selection pressure applied via MTX to upregulate expression of Gene of Interest. Can increase titer up to 2-fold	3 weeks
Optional Fed-batch Shake-Flask Production	Fed-batch production in shake-flasks to produce early material	2 – 3 weeks
	Reporting & Transfer of Stable Pools, Supernatants, or Purified Proteins (Go/No-Go)
Single Cell Cloning, Expansion, and Screening	Single cell dispensing into 96 well plates from pools. Identification of growing clones and expansion Screening for high titer clones Selection of up to 24 clones Verification of monoclonality	4 Weeks
Production Models and Selection of Top Clones	Fed-batch production of top clones to further screen for top producers	3 Weeks
RCB Banking of Top Clones	Research Cell Banks made of top ~3 clones BSE/TSE statement provided Verification of monoclonality Documentation of cell history	2 Weeks
	Reporting & Transfer of Stable Pools, Supernatants, or Purified Proteins (Go/No-Go)
Expression and Genetic Stability Study of Top Clones	Mock production to confirm stability of cell lines during manufacturing 9+ week cultivation of top producers Samples taken at various timepoints and analyzed for expression and genetic stability	13 weeks
Upstream Process Development	Optimization of media and expression conditions to maximize yield 2x 1 L single use bioreactors Production of pre-clinical material	3+ weeks
Purification and Downstream Process Development	Affinity purification for rapid delivery of purified product Development of a downstream process customized for your protein	2+ weeks
Characterization and Analysis	Customized analytical packages leveraging full range of protein characterization methods	2+ weeks
Formulation	Stability studies, buffer optimization, and more to create the optimal formulation for your protein	2+ weeks
	Reporting and Delivery of Purified Protein

Additional Services:

Cell Line Engineering
Glyco-engineered cell lines

For further information
please contact:

Ryan Polito
Business Development
Manager