Scale Up & cGMP ManufacturingYou 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 Plasman Mammalian Cell Culturen Primary Cell Culture

Scale Up & cGMP Manufacturing

Highlights of our manufacturing capabilities and capacities:

Tissue Processingn Dedicated Grade C (Class 100,000:ISO 8)

suites through configurable HVAC systems

Protein ManufacturingUpstream

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.)

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

your trusted partner for contract protein development & manufacturing