Know how

Custom monoclonal antibody process development

GTP is a Contract Development and Manufacturing Organisation (CDMO) with structured process development services for monoclonal antibody projects. Our know-how is based on our extensive experience in the production of a great variety of challenging recombinant proteins and antibodies.

GMP-ready processes to efficiently manufacture your monoclonal antibodies

Extensive expertise in mAb production

In most monoclonal antibody development projects, compressing timelines to get to the clinical batch is essential. GTP has the expertise it takes to help you move your project forward. Our experience with early stage monoclonal antibody production and process development covers over 50 monoclonal antibodies and antibody fragment programmes for both therapeutic and diagnostic purposes: IgG1s, IgMs, Fabs, ScFv, VHH, diabodies, Fc fusion proteins…

Custom CDMO services to fit every project

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

For early activity studies, we have developed an efficient transient transfection platform, in both HEK and CHO cells, ideal for proof-of-concept and antibody screening programmes. GTP can produce up to hundred antibodies in parallel for screening purposes.

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.

Fast-track upstream and downstream process development

Our monoclonal antibody 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.

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

Our downstream process development team applies 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