Scale Up & cGMP Manufacturing
Scale Up & cGMP Manufacturing You have taken your drug candidate as far as you can. It is time to scale up your process from 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 for protein and antibody scale up and cGMP manufacturing experience? Therapure is your trusted partner who can meet your process scale up and cGMP manufacturing needs. Therapure Biopharma operates a 130,000 ft2 world-class facility with over 28,000 ft2 of cGMP manufacturing space. Operating a range of classified suites from Grade A (Class 100:ISO 5) through Grade C (Class 100,000:ISO 8), Therapure maintains utilities compliant to USP and EP including Water for Injection, Purified 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 specific Standard Operating Procedures (SOPs), Batch Production Records, Analytical Test Methods, Product Specifications and Process Flow Diagrams. We work as an extension of your organization, adding value as your trusted manufacturing partner. When batch manufacturing starts, we encourage clients to be onsite, observing the manufacturing runs with us. Upon completion, we review the run with the client, going through every technical aspect of the batch records in order to fine tune the process for 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
Highlights of our manufacturing capabilities and capacities: Tissue Processing n Dedicated Grade C (Class 100,000:ISO 8) suites through configurable HVAC systems
Protein Manufacturing Upstream n Mammalian cell culture processes (CHO, HEK-293, Hybridoma, etc.) n Microbial processes (through strategic partnerships) n Master Cell Bank (MCB) creation n Seed train from 5L to 500L Single Use Bioreactors (SUBs) n Media preparation up to 6,000L batches
Midstream n Harvest by nominal flow filtration, tangential flow filtration or centrifugation n Viral inactivation tanks (pH, solvent-detergent, temperature) n Nanofiltration
Downstream n Dedicated ‘non-live’ processing area n Chromatographic volumetric rates from 10mL/min to 10L/min n Ultrafiltration / diafiltration up to 100 m2 of membrane n Protein modification (conjugation, refolding, enzymatic conversion, etc.)
your trusted partner for contract protein development & manufacturing
n Buffer preparation up to 6,000L batches n Bulk filling
Therapure Biopharma Inc. 2585 Meadowpine Boulevard, Mississauga, Ontario Canada L5N 8H9 Telephone: +1 905 286 6200 Fax: +1 905 286 6300
www.therapurebio.com