Technology transfer and process developmentDocument Transcript
Technology Transfer & Process DevelopmentTechnology Transfer& Process DevelopmentYou have spent years in the laboratory developinga promising therapeutic protein that not only hastremendous market potential for your company butalso global value in terms of the treatment of an unmetmedical need. It has now come to that critical pointin the program where you must choose a CDMO totake your therapeutic protein to the next level. But towhom can you turn with your valuable product? Whowill take your therapeutic protein to that next levelwhile respecting your requirements and continuing toinvolve you in the development process? Therapureis your trusted partner for efficient technology transferand developing your manufacturing processes.Therapure understands the time and effortinvested into your drug candidate. It is our goal to learn from your experience through our comprehensive Technology Transfer program that is designed to quickly and effectively transfer materials and to convey critical product knowledge from your team to ours. Through the creation of a joint Technical Project Team, we are able to effectively steer the development and manufacturing program ensuring your milestones are met. Following project kick-off, Therapure’s extensive development experience comes to bear as your project is transferred to our labs. Therapure can provide a variety of product and process development services including the creation of a stable cell line or the optimization and scale up of your existing manufacturing process.
Therapure has the experienceand service offerings for processdevelopment and optimizationMolecular biologyn Vector design and constructionn Host cell line transfection, amplification and selectionCell banking (RCB, MCB, WCB)Upstream cell culture developmentn Media selection and screeningn Pre-culture optimizationn Cell density and product expression optimizationn 5L to 50L lab-scale cell culture capabilityMidstream harvest developmentn Filtration (NFF, TFF)n CentrifugationDownstream process developmentn Resin screening, selection and initial scoutingn Chromatography column optimization and scale upn Tangential Flow Filtration (TFF) operationsn Protein characterizationn Viral inactivation/removal proceduresProduct & buffer formulation developmentn Buffer composition development and stability testingn Lyophilization cycle development and optimizationn Bulk and final product stability testingAnalytical method development your trusted partner for contract protein development & manufacturingn In-process and release testing Therapure Biopharma Inc. 2585 Meadowpine Boulevard, Mississauga, Ontario Canada L5N 8H9 Telephone: +1 905 286 6200 Fax: +1 905 286 6300 www.therapurebio.com