Scale Up & cGMP Manufacturing You have taken your drug candidate as ar as you can. It is time to scale up your process rom the bench to clinical or commercial size batches. But is your process robust enough? Will it stand up to a 5, 10, 50 or 100 times scale up? Who can you turn to or protein and antibody scale up and cGMP manuacturing experience? Therapure is your trusted partner who can meet your process scale up and cGMP manuacturing needs. Therapure Biopharma operates a 130,000 t 2 world-class acility with over 28,000 t 2 o cGMP manuacturing space. Operating a range o classied suites rom Grade A (Class 100:ISO 5) through Grade C (Class 100,000:ISO 8), Therapure maintains utilities compliant to USP and EP including Water or Injection, Puried Water, Clean Steam and Oil-Free Compressed Air. During process scale up, Therapure keeps its clients engaged in the project, actively soliciting decisions on raw materials, components, consumables, process specic Standard Operating Procedures (SOPs), Batch Production Records, Analytical Test Methods, Product Specications and Process Flow Diagrams. We work as an extension o your organization, adding value as your trusted manuacturing partner. When batch manuacturing start s, we encourage clients to be onsite, observing the manuacturing runs with us. Upon completion, we review the run with the client, going through every technical aspect o the batch records in order to ne tune the process or the next run. Therapure has experience utilizing a variety of different sources of API including: n Whole Blood and Plasma n Mammalian Cell Culture n Primary Cell Culture Scale Up & cGMP Manuacturing