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Technology Transfer & Process Development




Technology Transfer
& Process Development
You 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.


                                                            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                                your trusted partner
                                                               for contract protein development & manufacturing
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

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Technology transfer and process development

  • 1. Technology Transfer & Process Development Technology Transfer & Process Development You 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. 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.
  • 2. 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 your trusted partner for contract protein development & manufacturing 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