Cell Line Development

GBI scientists have considerable experience in the development of cell lines for cGMP manufacturing for clinical studies through commercial manufacturing. GBI offers a full range of mammalian cell culture development services including:

• Selection of clones
• Cell line evaluation and stability
• Cell line adaptation
• Medium development
• Development and optimization of robust and scalable processes
• Development Cell Banks

This experience includes working with most cell lines used for manufacturing, including CHO, NS0, BHK, 293 as well as murine hybridomas. We have experience with all selection systems used with these lines. Our experience includes surface dependent as well as suspension culture types.

• GBI offers evaluation and characterization services for your cell line. The characterization includes establishing and documenting the line's growth and product manufacturing dynamics. This data is crucial for determining whether the project is practical with the existing cell line capabilities and along with target product amounts, providing initial estimates for project costs.
• GBI offers medium evaluation and adaptation to commercial serum free formulations for your cell line. This service is to increase your line's productivity, growth performance, and/or compliance level.
• Another service offered to enhance the performance of your cell line is cloning. Cloning and screening for more productive clones may improve performance if your line has had limited cloning previously or has been exposed to conditions that would promote multiple cell performance populations.

Bioreactor Process Development

GBI offers three different types of bioreactor systems for production and process development services for each. We work with clients to determine the optimum bioreactor type to use for their project based on their cell expression system and product quantities needed.

• Stirred tank batch or fed-batch bioreactor
• Fibracell disk immobilized bed perfusion bioreactor
• Hollow fiber bioreactor

GBI has available small bioreactor systems of each type for the development of specific run parameters and scaling data for the larger production bioreactors. These small systems are also available for the production of non-GMP material for testing and toxicology studies.

GBI's scientists have extensive backgrounds in the development of bioreactor processes and are able to design a process that will yield the required amount of bulk product material for your clinical trial needs.  As your product advances through its clinical evaluation, GBI can optimize, establish parameter limits, and document all aspects of the bioreactor process to enable a smooth transfer for commercial manufacturing.