Experience.
Scalability.
Upstream Processing Cell Culture Development
GBI offers robust and reproducible cell culture upstream process development services for producing complex therapeutic protein drug candidates.
In fact, many of GBI’s projects involve monoclonal antibodies and recombinant proteins (many with drug/chelator conjugates) that proceed through upstream process development and cGMP manufacturing.
We ensure from the earliest stage that any upstream process development project is scalable, compliant, and economical for large-scale cGMP manufacturing of products that meet quality and regulatory requirements for safety, purity, potency, identity, and immunogenicity through rigorous characterization.
GBI’s Methods for USP Cell Culture Development
To do so, we develop and optimize robust methods and scalable processes that are qualified and/or validated during pre-clinical, early-stage, and late-stage development. This begins with media selection and animal-free component development designed to increase your cell line’s productivity, growth performance, and/or compliance level.
We have experience with various upstream cell culture technologies in the Process Development Lab including stationary culture disposable flasks, cell factories, spinners, WAVE, stirred tank and fed-batch bioreactors, and perfusion processes. Though we have three different types of bioreactor systems for production (with process development services for each), GBI also offers cell culture production for non-bioreactor projects.
GBI has significant experience in working with companies like ours and the capabilities to provide the scale-up needed for a late-stage clinical trial. GBI's competencies in process and product implementation, quality assurance, and GMP manufacturing make it ideally suited as a manufacturing partner.
