Capabilities

Upstream process development - Mammalian & Insect

With over 300 such projects handled to date, GTP has a rich experience in cell culture with a variety of mammalian or insect expression systems.

Our mammalian and insect process development services aim at delivering GMP-ready upstream processes

We develop upstream process approaches, customised for your final objectives

When your requirement is milligrams of material for research or POC studies, we will choose expression platforms that allow for short turnaround times and high expression levels. For expression in mammalian cells, we offer a CHO technology with lead times as short as those of transient transfection but with the advantage of stable cell pools, that can be banked and reused for subsequent or larger needs.

For projects in later development stages, we provide USP development services both for mammalian and insect cells. They are devoted to defining optimal culture parameters for the desired titer and quality attributes while ensuring process robustness and scalability. Our offer includes fast-track process development for situations where timelines need to be condensed. We also offer flexibility and the ability to adapt to quick process change requirements that happen in bioprocess development.

Our experienced team will deliver a robust, efficient and scalable upstream process, ready to transfer

We offer a comprehensive set of process development services to deliver GMP-ready upstream processes:

  • Cell line development.
  • Cell line adaptation (e.g. to serum-free or suspension culture).
  • Generation of cell banks (RCB & MCB).
  • Media & feed development and optimisation
  • Development of batch, fed-batch or perfusion processes.
  • Identification of critical process parameters.
  • Optimisation of existing processes.
  • Support for transfer to manufacturing.

Cell line development is performed through partnerships with technology companies. Depending on your requirements and constraints, we will choose between IP-free or proprietary technologies to develop high-expressing cell lines.

We will start an upstream programme by studying the cellular behaviour in different growth conditions to select clones with appropriate growth characteristics. We will then work on the development and optimisation of the culture conditions with media and feeding strategies. Next, the process will be transferred to a bioreactor to define the settings and process range and perform consistency runs for process confirmation.

Our cell culture facilities host the appropriate equipment for each development stage, from small to pilot scale:

  • Screening experiments: spinner, shake flasks, roller bottles.
  • Process development bioreactors: 3 to 10L.
  • Pilot bioreactors: 10L to 100L.
Mammalian cells development 1 Mammalian cells development 2