Know how

Process development for monoclonal antibodies

GTP offers structured process development services, thanks to our extensive experience producing a great variety of challenging recombinant proteins and antibodies.

Our service fits customer demand for fast-track process development

We have the expertise to take your mAb project from early development to transfer to manufacturing

In most monoclonal antibody development projects, compressing timelines to the clinical batch is essential.

Our experience with early stage mAb production and process development spans over 50 monoclonal antibodies and antibody fragment programmes for both therapeutic and diagnostic purposes: IgG1s, IgMs, Fabs, ScFv, VHH, diabodies, Fc fusion proteins…

Our process development team offers all the resources needed to provide either gram quantities of your antibody for stability and activity studies, or the process and analytical development necessary to reproducibly yield an antibody with the required purity and quality attributes.

Our Mab process development service fits customer demands for fast-track process development, which we manage by aligning our work with our CMO partners’ prerequisites. For mAb development projects for orphan drugs, ADC and diagnostics, we have a privileged partnership with Novasep to provide full CDMO services from gene to market.

With our comprehensive range of capabilities we meet all your mAb process development needs

For early activity studies, we offer an innovative CHO technology ideal for proof-of-concept and screening programmes. The technology is well suited for expression trials involving multiple antibody variants in parallel. The resulting cell pools can be banked and re-used in later productions. If and when larger quantities of your selected antibody candidates are needed, scaled-up productions are quick and easy to provide.

Through partnerships with technology companies, we offer CHO cell line development and banking services. Depending on your requirements and constraints, we will choose between IP-free or proprietary technologies to develop high-expressing mammalian cell lines.

During upstream development, we will optimise the cell culture parameters for high titer and critical quality attributes while ensuring process robustness and scalability.

Our downstream development team will apply platform approaches to accelerate antibody development, while always considering and addressing the unique challenges that every therapeutic protein presents.

 

Process dev mAbs 1 Facilities 4