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Mammalian Process Development

GTP Bioways is a CDMO with strong expertise in process development. Our team has long-standing experience in developing mammalian processes for standard mAbs as well as for challenging antibody formats and proteins.
GTP Bioways CDMO - CMC Development

Best-in-class mammalian process development services

We know that the time spent for process development is an investment into the future success of programme and will focus on developing a robust and efficient process for your therapeutic antibody or protein.

For mAbs, our standard approach for process development is based on the optimisation of our platform upstream and downstream processes to shorten the time to clinic.

We are also happy to take on all protein process development projects, even those that do not fall under well-established standards, and we have unique experience in developing efficient processes from scratch for the most challenging proteins.

STEP 01. Late Discovery

STEP 02. Preclinical Development

years

For 20 years, our team has successfully been developing mammalian processes for a wide variety of biotherapeutics

including monoclonal antibodies, engineered antibodies, immunocytokines, antibody fragments and Fc- fusion proteins

Cell line Development process

Customised mammalian upstream bioprocess development

Our highly experienced USP team has successfully developed mammalian processes for the production of standard mAbs as well as of challenging antibody formats and proteins.

Our experience across a diversity of CHO and HEK cell lines – either developed in-house or transferred from a third party – allows us to develop cell culture processes on short timelines. From media development to fed-batch process optimisation, we have the know-how to deliver highly productive, robust, and scalable upstream processes for a seamless transfer to GMP manufacturing.

Expert downstream process development services

Our scientists regard each protein as a unique challenge and have the agility to customise downstream processes to each specific case.

To shorten the time to clinic for mAbs, our process development approach is based on the fine-tuning of our optimised downstream platform to your specific antibody candidate.

For other proteins, our team is used to developing purification schemes from scratch, optimising each downstream unit operation to obtain an efficient, robust, and cost-effective process. When classic technologies are not applicable, we bring innovation into the process, with manufacturability always in mind.

GTP Bioways CDMO - Bioconjugates Analytical Development

Discover more about GTP Bioways services

Mammalian Manufacturing

GMP Manufacturing

Biologics

Analytics & Formulation

Biologics

Fill & Finish