Celonic’s exosome and microvesicle development platforms are fully equipped to transfer, develop and scale-up a broad range of candidate therapeutic solutions. The capabilities and expertise present at Celonic provide greater flexibility in project on-boarding, irrespective of development stage. Currently, Celonic has ongoing EV development projects in both early and late-stage development.
Celonic’s capabilities include:
- Experience with multiple cell lines – native and engineered
- Ability to produce naive, engineered and cargo-loaded EVs
- Established USP and DSP development and scale-up
Cell line development for EV production
Celonic offers cell line development (CLD) with a wide range of cell lines, including client-produced cell lines, native and engineered cell lines, as well as the human GEX® cell line – optimized for use in perfusion processing at up to 1000 L scale.
Celonic’s CLD capabilities include:
- Well-characterized and scalable GEX® platform experience with many successful GMP batches
- Regulatory compliance with products expressed in GEX® having been approved by U.S. and European authorities
- High-efficiency as well as high-throughput plasmid transfection
- Automated clone imaging and screening
EV production – USP development
Celonic’s highly experienced upstream process (USP) development team provides robust EV production and scale-up.
Celonic’s USP capabilities include:
- Suspension and adherent cell culture
- Perfusion and fed-batch cell culture
- Process scaling (up and out)
EV purification – DSP development
We use state-of-the-art downstream process (DSP) instrumentation and methodologies to achieve EV isolation and purification, including:
- Immuno/affinity capture
- Size-exclusion and ion-exchange chromatography
- Tangential flow filtration (TFF)