Preclinical / Early Phase
Celonic’s new GS-CHOvolution® expression system*
Celonic’s GS-CHOvolution® offers a gene-edited Glutamine Synthetase (“GS”) knockout Chinese Hamster Ovary (CHO) K1 cGMP-compliant cell line including TnT transposon technology which facilitates the selection of high expressing clones during cell line development. Celonic’s GS-CHOvolution® is suitable for Monoclonal Antibodies (mAbs), Bispecifics and other complex proteins. Celonic offers small and large Biotech clients a world class expression platform with a simplified License fee model without royalties.
* Based on Revvity’s CHOSOURCE™ Technology
GS-CHOvolution® Platform
- Well-established industry standard for Bioproduction/manufacturing
- Non-antibiotic based selection. No MSX
- Recognised by regulators as suitable for manufacture of biologics
- Accelerated cell line development timelines with high efficiency cell line screening
- Robust and Scalable platform (No Glutamine supplementation required)
Cell Line Development
Celonic has a proven track record in Cell Line Development with decades of hands on experience with CHO based molecules. Over the past years, about one third of all Cell Line Development programs at Celonic have been “complex” including bispecifics, multi-specifics and fusion proteins.
Celonic’s standard Antibody development from Gene to Drug Product is less than 12 months. Our non-GMP Biologics Development Center with 200L Pilot Plant also allows to generate Tox material on a fast timing. Celonic offers the option for Cell Line Development workflow optimization, which can accelerate timelines based on the risk appetite of the client.
Celonic’s approach to development is based on a philosophy of balancing speed with derisking. We offer our clients integrated solutions based on high throughput automation and disciplined analytics to improve efficiency and productivity.
Process Development
USP Development
Our highly experienced USP development team provides you with robust and cost-efficient process development. From media screening to process optimization, we have the know-how to adapt and optimize processes in order to increase expression titer and strengthen cell viability.
- Media screening
- Feeding optimization
- Optimization of process parameters
- Shear stress testing
- Small scale volume bioreactor systems for non-GMP development and affordable pilot runs.
DSP Development
Efficiency is the key for a good downstream process to obtain consistently a pure and high quality product while recovering as much target protein as possible. Celonic has set up a downstream platform process for antibodies, often with a yield of 65-70% + of the target mAb. This saves considerable development time and costs and reduces the cost per gram of the final drug substance.
- Adaption of state-of-the-art purification processes for mAbs
- Process development for complex molecules
- Process intermediate stability studies
- Virus clearance studies
Analytical Method Development
Our analytical method development department is equipped with state of the art instruments, such as capillary electrophoresis and mass spectroscopy, providing a broad spectrum of relevant standard antibody methods. Celonic also has substantial experience in developing analytical methods for non-mAb complex molecules.
We perform method development, including GMP-compliant method validation and stability studies. We also collaborate with well-established partners with extensive experience in specialized characterization methods so that we can offer a full service within an all-round care package.
We have expert knowledge of a range of molecules, such as monoclonal antibodies, antibody fragments, fusion proteins, blood factors and enzymes. Celonic is also experienced in developing analytical strategies for biosimilars, including Reference products sourcing.
We have outstanding technical expertise and put a strong focus on our collaboration partners and clients. Flexibility, fast individual response and customer support are a natural part of our daily business.
