SERVICE
cGMP Manufacturing of mAbs
We adapt the scale and platform to your needs
mAbs production
Global biomanufacturing is facing a major bottleneck with existing capacity currently unable to adequately support production of therapeutic recombinant proteins and monoclonal antibodies.
Exothera has two new state-of-the-art GMP manufacturing facilities to develop new therapies and deliver complex projects more quickly and cost-effectively. Our two dedicated development and manufacturing facilities are available for recombinant proteins and monoclonal antibody manufacture.
Our capability stack
Facilities
Manufacturing spaces available immediately
State-of-the-art facilities – right size with scalable platforms (from small scale (50L) to intermediate (200L) to production scale (2x2000L)) and different types of technology in one facility;
A 15,000 m² site in Brussels South area, Belgium housing laboratories, clean rooms, and GMP-qualified manufacturing areas for clinical and commercial production.
Technology
The right technology to fit you drug
Suspension cell culture (200l to 2 x 2000l or equivalent);
Choice of cutting-edge technology options: Stirred tanks and Rock Motion disposable bioreactors. – to maximize titre.
Expertise
A team of industry veterans
Bioproduction, GMP and quality experts with proven industry track records;
Our laboratories are fully equipped to offer rigorous analytical services.
Quality
The highest European standards
Data-driven process design and optimization;
Every stage is designed with quality in mind – so we do it right the first time;
The Analytical Science (AS) team develops our analytical method portfolio to respond accurately in the shortest possible time providing our customers with the most recent technologies and knowledge to support their projects.
Rigorous QC and QA applied throughout the process.
Our approach
Extensive experience with suspension STR processes and high throughput PD capacity to support DoE and streamlining scale-up of STR processes.
Upstream approach
- EStable expression CHO lines cultured in suspension
- E“Textbook” scalable bioreactor processes with up to 2000L fully single-use architecture
- E“Fed-batch and perfusion” processes with complex feeding regime
- EOptimization of the CQAs and expression of the target through chemical composition of media, feeding regime, physical parameters in the bioreactor and other parameters
- E“Long” processes with 8 to 16 production phase duration
- EVery well understood at Exothera due to multiple works on biosimilars development in the past
Allegro STR Single-Use Bioreactor
2000L
Midstream and downstream approach
Midstream is key to successful performance of downstream – we focus on minimizing the number of unit operations, increasing productivity of process and recovery.
