SBMP - disrupting the manufacturing of biological drugs through a ground-breaking nanotechnology-based microcarrier

Informazioni relative al progetto

SBMP-microcarrier

ID dell’accordo di sovvenzione: 190187799

DOI

10.3030/190187799

Progetto chiuso

Data della firma CE 11 Novembre 2022

Data di avvio 1 Ottobre 2022

Data di completamento 30 Settembre 2024

Finanziato da

• The European Innovation Council (EIC)

Costo totale

€ 3 551 225,00

Contributo UE

€ 2 485 857,50

Coordinato da

CELLEVATE AB
Sweden

Periodic Reporting for period 2 - SBMP-microcarrier (SBMP - disrupting the manufacturing of biological drugs through a ground-breaking nanotechnology-based microcarrier)

Periodo di rendicontazione: 2023-10-01 al 2024-09-30

Sintesi del contesto e degli obiettivi generali del progetto

Biologics, including cell- and gene therapies, represent a new medical paradigm with revolutionary potential for treating various diseases. The global biomanufacturing market, valued at EUR 20 billion, is projected to reach EUR 40 billion by 2030. However, next-generation therapies (NGTs) face significant manufacturing challenges, including low yields, high costs, and difficulties scaling processes from R&D to clinical manufacturing. This has led to a "biomanufacturing revolution," as companies urgently seek scalable, sustainable, and cost-effective production solutions.

Cellevate’s innovative Cellevat3d® platform addresses these challenges. Our nanofiber microcarriers are designed to improve bioprocessing efficiency, offering disruptive and scalable solutions for biologics manufacturing. By tackling critical issues in upstream processing, the platform enhances production economy, reduces costs, and accelerates market access for NGTs. The project aimed to optimize production methods, validate performance, and support commercial launch while addressing industry demands.

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

The project was structured into 7 work packages (WPs) and 4 milestones (MS):

• Innovation-related work packages (TRL 5-8):
o WP1: Project management
o WP2: Production process optimization
o WP3: Validation studies
o WP4: Production scale-up
o WP5: Market access, dissemination, communication

• Market deployment activities (TRL 9):
o WP6: Commercialization and scale-up management
o WP7: Marketing, customer acquisition, sales

• Milestones:
o MS1: Validation studies with research partners completed
o MS2: Manufacturing method optimized and validated with industry partners
o MS3: Final production line ready
o MS4: Commercial rollout achieved (ahead of schedule in November 2024).

Key technical achievements include evaluation and optimization of 10+ Cellevat3d® material candidates (twice the planned scope). The cellulose-based nanofiber microcarrier with quaternary ammonium functionalization demonstrated superior performance for AAV vector production (gene therapies) and was selected for validation.
Collaborations expanded from the originally planned 4 to 31 partners, including:
• Fraunhofer Institute: Benchmarking and process economy in bioreactors
• Charles River Laboratories: AAV production validation
• Testa Centre: Large-scale gene therapy production
• Karolinska Institutet: Stem cell therapy production
• Max Planck Institute: Novel vaccine production.

Validation success led to rapid commercial progress, with 40+ customers in final discussions and 7 product quotes secured by project end. Internal cell culture facilities were established to accelerate data generation, enhance IP development, and improve risk management.

The Cellevat3d® nanofiber microcarriers demonstrated remarkable results: a 3.1-fold increase in AAV9 vector yield compared to current standards, supporting scalable solutions for adherent cell cultures. Production processes were optimized, and manufacturing was scaled to industry standards, including expanded facilities and equipment readiness for further scale-up.

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)

Cellevat3d® nanofiber microcarriers provide a sustainable, scalable solution for upstream bioprocessing. They enable homogeneous 3D dense cultures with high yields while reducing shear forces in bioreactors. Benchmarking data revealed high transfection efficiency and volumetric productivity, achieving a 3.1-fold increase in AAV9 vector yield compared to current microcarriers. These advancements enhance gene therapy production strategies by reducing costs and improving accessibility to biologics.

Stem cell applications were also explored, with Cellevat3d® macrocarriers achieving a 19-fold increase in hMSC density within 8 days while maintaining >90% cell viability. Retrieved cells retained morphology, proliferation rate, and key stemness markers, confirming high-quality production suitable for cell therapy applications.

Two IP filings were submitted:
• EP24180000.2: Process for culturing stem cells
• EP24155092.0: Production of AAVs.

These patents facilitated customer validations, with 15 out of 31 partners engaged, 11 receiving materials, and 6 generating critical launch data. Early data enabled Cellevat3d®’s nanofiber microcarriers’ global launch a year ahead of schedule in November 2024. The product is now available for order at cellevate.com.

The project’s success accelerated Cellevate’s commercialization phase, supported by a €3.3M rights issue with participation from Industrifonden, EIC Fund, and Onsight Ventures. Preparations for a Series A funding round (€15M) in mid-2025 are underway to scale production, support commercialization, and meet increasing demand in the EU and US.

Cellevate is now focusing on:
1. Scaling up production to meet customer requirements.
2. Expanding the Cellevat3d® product portfolio for large-scale viral vector and stem cell applications.
3. Strengthening market access, stakeholder engagement, and scientific leadership.

The Cellevat3d® platform delivers innovative, high-performance solutions for next-generation therapies. With demonstrated increases in productivity, cost-effectiveness, and scalability, the platform addresses critical biomanufacturing challenges. By accelerating market readiness and achieving milestones ahead of schedule, Cellevate is well-positioned to drive the biomanufacturing revolution, enhancing access to life-changing biologics worldwide.