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Scale Up & cGMP ManufacturingYou 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 t2 world-class

acility with over 28,000 t2 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 onraw 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

starts, 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 aspec

o the batch records in order to ne tune the process orthe next run.

Therapure has experience utilizing a variety

of different sources of API including:

nWhole Blood and Plasma

nMammalian Cell Culture

n Primary Cell Culture

Scale Up & cGMP Manuactur

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Highlights of our manufacturing capabilities and capacities:

Tissue Processing

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

suites through congurable HVAC systems

Protein Manufacturing

Upstream

nMammalian cell culture processes (CHO,

HEK-293, Hybridoma, etc.)

nMicrobial processes (through strategic partnerships)

nMaster Cell Bank (MCB) creation

n Seed train rom 5L to 500L Single Use Bioreactors

(SUBs)

nMedia preparation up to 6,000L batches

Midstream

n Harvest by nominal fow ltration, tangential fow

ltration or centriugation

n Viral inactivation tanks (pH, solvent-detergent,temperature)

n Nanoltration

Downstream

n Dedicated ‘non-live’ processing area

n Chromatographic volumetric rates rom 10mL/min

to 10L/min

n Ultraltration / dialtration up to 100 m2 o membrane

n Protein modication (conjugation, reolding,

enzymatic conversion, etc.)

n Buer preparation up to 6,000L batches

n Bulk lling 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