Technology Transfer And 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 :-

• Vector design and construction
• Host cell line transfection, amplification and selection

Cell banking (RCB, MCB, WCB)

Upstream cell culture development :-

• Media selection and screening
• Pre-culture optimization
• Cell density and product expression optimization
• 5L to 50L lab-scale cell culture capability

Midstream harvest development :-

• Filtration (NFF, TFF)
• Centrifugation

Downstream process development :-

• Resin screening, selection and initial scouting
• Chromatography column optimization and scale up
• Tangential Flow Filtration (TFF) operations
• Protein characterization
• Viral inactivation/removal procedures

Product & buffer formulation development :-

• Buffer composition development and stability testing
• Lyophilization cycle development and optimization
• Bulk and final product stability testing

Analytical method development :-

• In-process and release testing