Technology Transfer & Process DevelopmentYou have spent years in the laboratory developing

a promising therapeutic protein that not only has

tremendous market potential for your company but

also global value in terms of the treatment of an unmet

medical need. It has now come to that critical point

in the program where you must choose a CDMO to

take your therapeutic protein to the next level. But to

whom can you turn with your valuable product? Who

will take your therapeutic protein to that next level

while respecting your requirements and continuing to

involve you in the development process? Therapure

is your trusted partner for efficient technology transfer

and developing your manufacturing processes.

Therapure understands the time and effort invested into your drug candidate.

Technology Transfer & Process Development

It is our goal to learn from your experience through our

comprehensive Technology Transfer program that is

designed to quickly and effectively transfer materials

and to convey critical product knowledge from your

team to ours. Through the creation of a joint Technical

Project Team, we are able to effectively steer the

development and manufacturing program ensuring

your milestones are met.

Following project kick-off, Therapure’s extensive

development experience comes to bear as your

project is transferred to our labs.

Therapure can provide a variety of product and process development services including the creation of a stable cell line or the optimization and scale up of your existing manufacturing process.

Therapure has the experience and service offerings for process development and optimization

Molecular biology

n Vector design and construction

n Host cell line transfection, amplification and selection

Cell banking (RCB, MCB, WCB)

Upstream cell culture development

n Media selection and screening

n Pre-culture optimization

n Cell density and product expression optimization

n 5L to 50L lab-scale cell culture capability

Midstream harvest development

n Filtration (NFF, TFF)

n Centrifugation

Downstream process development

n Resin screening, selection and initial scouting

n Chromatography column optimization and scale up

n Tangential Flow Filtration (TFF) operations

n Protein characterization

n Viral inactivation/removal procedures

Product & buffer formulation development

n Buffer composition development and stability testing

n Lyophilization cycle development and optimization

n Bulk and final product stability testing

Analytical method development

n In-process and release testing

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