AlkaBurst2.0 – A game changing bioreactor for sustainable production of active pharmaceutical ingredients in a consistent, traceable and low cost approach

Informazioni relative al progetto

AlkaBurst2.0

ID dell’accordo di sovvenzione: 190110623

DOI

10.3030/190110623

Progetto chiuso

Data della firma CE 26 Ottobre 2022

Data di avvio 1 Novembre 2022

Data di completamento 31 Luglio 2025

Finanziato da

• The European Innovation Council (EIC)

Costo totale

€ 3 586 937,50

Contributo UE

€ 2 500 000,00

Coordinato da

ALKION BIOINNOVATIONS
France

Periodic Reporting for period 2 - AlkaBurst2.0 (AlkaBurst2.0 – A game changing bioreactor for sustainable production of active pharmaceutical ingredients in a consistent, traceable and low cost approach)

Periodo di rendicontazione: 2023-11-01 al 2025-07-31

Sintesi del contesto e degli obiettivi generali del progetto

The pharmaceutical sector increasingly depends on complex biological ingredients whose production still relies on resource-intensive crops, long supply chains, and fragile natural ecosystems. QS-21 – a key component of many next-generation prophylactic and therapeutic vaccines – is one such ingredient: today it is obtained from the bark of Quillaja saponaria, a slow-growing Chilean tree, through processes that are costly, environmentally constrained and unable to meet growing global demand.
The objective of the AlkaBurst project was to develop a sustainable, scalable and European alternative for producing QS-21 and other high-value plant-derived compounds. To do so, Alkion BioInnovations aimed to build an automated pre-industrial biorefinery based on its proprietary temporary-immersion bioreactor platform, to optimise plant-based bioproduction processes, and to prepare their integration into future GMP manufacturing. The project also sought to refine the commercial strategy and engage the ecosystem needed for future deployment in global health, veterinary vaccines and biodefense.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

During the project, with extensive cellular and molecular biological R&D, Alkion established a complete bioproduction workflow for Quillaja biomass: in-vitro culture, scale-up in large temporary-immersion bioreactors, elicitation, extraction and purification. A new generation of 40-L modular “Alkaburst 2.0” bioreactors was designed, engineered and validated, offering reproducible biomass growth, reduced contamination risks, and seamless scalability through parallel operation.
The company also advanced its extraction and purification processes, enabling the production of highly purified QS-21 and several related saponin fractions. Analytical comparisons confirmed equivalence with pharmaceutical-grade reference materials. These advances were consolidated into a full process book and used to define the future GMP roadmap, supported by expert audits.
In parallel, Alkion progressed on automated micropropagation through AI-assisted robotic cutting (in partnership with an external robotics company), and engaged in multiple pre-clinical collaborations with NGOs, academic groups, CDMOs, and biotech companies. These collaborations now evaluate Alkion’s QS-21 and associated adjuvant systems in various human and veterinary vaccine programmes.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

The project has delivered a unique plant-cell-culture-based alternative to current QS-21 sourcing, replacing tree bark harvesting with a controlled, year-round, industrial process enabling 6-weeks production cycles (compared to 7 years in forest) and yields multiplied by 20. The 40-L Alkaburst modules represent a step-change in automated plant bioproduction: fully traceable, optimised for aseptic handling, compatible with robotic inoculation, and able to scale by multiplication rather than reactor enlargement—dramatically reducing risks and improving reproducibility.
The project also achieved major breakthroughs in purification, enabling the production of high-purity QS-21 and consistent saponin profiles suitable for pre-clinical and, after GMP implementation, clinical development. By integrating robotics soon deployed, AI-assisted micropropagation, and a standardised biorefinery design, Alkion is establishing a technology platform that can be deployed rapidly for multiple high-value plant-derived molecules.

2025: A production unit of new-40L-Alkaburst running in parallel in Alkion’s culture chamber[...]

Alkion's new labs and facility in Versailles

Extraction and purification labs

Micropropagation labs

New hood room for micropropagation.

Biomol labs

Alkion's culture chamber with lab-scale bioreactors