Cell Culture Process Development

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•Goodwin Biotechnology Brochure

Goodwin Biotechnology provides GMP compliant cell banking services that include manufacturing of seed, master, working and post-production banks. Bank sizes up to 200 vials can be manufactured.

GBI scientists have considerable experience in both process development and in the operation of cell culture processes under cGMP conditions for Phase I / II clinical studies. GBI offers a full range of mammalian cell culture development and manufacturing services including:

• Selection of clones
• Cell line evaluation and stability
• Cell line adaptation
• Medium development (both animal component and animal-free components)
• Development and optimization of robust and scalable processes
• Development Cell Banks

GBI has experience working with most cell lines used for manufacturing, including CHO, NS0, BHK, 293 as well as murine hybridomas. We have also worked with several different selection systems such as dhfr - /methotrexate CHO, mycophenolic acid/xanthine, and G418 systems. 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.
• Cell Banking - GBI offers a full array cell banking services. Banks can be prepared for research or manufacturing use. Manufacturing banks include seed, master, working, and post production. All of these banks are GMP compliant and are tested based on the current Points to Consider for cell bank testing. GBI works closely with our client and with our qualified contract testing organizations to assure acceptability of all testing. Banks are prepared using a controlled freeze rate system and are stored in either liquid nitrogen or in - 150º C mechanical freezer systems. All bank inventories are secured and controlled by GBI's Quality department. Short or long term storage of cell banks is provided.
• GBI offers cell culture production services for non-bioreactor projects. Spinner flasks up to eight liters in volume and roller bottles totaling up to 68,000 cm 2 are available for production.

Click Here To Download:
•Goodwin Biotechnology Brochure