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,
your trusted partner
enzymatic conversion, etc.) 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