We will offer a comprehensive range of technical services to support the development, manufacturing, and analysis/QC of both allogeneic and autologous cell therapy products from starting material development and gene editing process development to product release and regulatory support. We will also provide a working environment for our users that’s designed to foster creativity and collaboration and accelerate growth.
Focus areas
How we're closing the gap
Cell line development & gene editing
Cellerator will provide access to both ES and iPSC cell lines and support sourcing and qualification of third-party cell lines, as well as licensing of platforms for gene editing and iPSC reprogramming. This includes initial cell line derivation and banking, ensuring high-quality and compliant cell lines for your projects.
Assay development & quality control”
We will provide comprehensive assay development services, including product characterisation, purity/impurity and potency. Assay validation and safety testing, including virus and microbiology rapid tests are also part of the offerings, ensuring high standards are met for release testing.
Process development
Process development labs will be equipped to facilitate a seamless transition from preclinical PoC to FHD. With equipment and capabilities for both adherent and suspension cell culture, we will assist in cell expansion, differentiation, and scaling, offering flexibility to adopt multiple platforms for any development needs
GMP manufacturing
Cellerator is designed to support specialized GMP manufacturing for phase I/II clinical trials. With a focus on quality and compliance, these capabilities are a cornerstone in the development and production of advanced cell therapies, providing a robust foundation for therapeutic innovation and patient care.
Fill, finish & cryopreservation
Will include aseptic filling and packaging in compliance with GMP standards, as well as cryopreservation services, utilizing state-of-the-art technology to preserve cell viability and function. The approach will guarantee cell therapies are delivered in the highest quality and ready for immediate use or long-term storage.
Regulatory support
Cellerator will offer expert regulatory support to navigate the complex landscape of cell therapy approvals and smooth the path to clinical trials. This includes assistance with regulatory filings, such as INDs and CTAs, and interactions with regulatory agencies to ensure compliance with current guidelines.
Supportive infrastructure
Clients using Cellerator will have access to lab and office space, as well as common areas that are more than just a place to grab coffee. They will be hubs of conversation and collaboration, with free use of meeting rooms and amenities to make the day-to-day experience comfortable and productive.
Centralized resources
We will offer a centralized procurement portal, allowing clients to efficiently purchase their own consumables, reagents and raw materials. This system streamlines purchasing and accounting operations and allows our users to focus on their research, development and manufacturing efforts.
Community engagement
The Cellerator will have a selective process to ensure that we are nurturing the most promising ideas and teams. We will arrange activities to facilitate company acceleration and networking, providing opportunities for our users to learn from each other and grow together.
Development plan
October 2024
BD completion & contractor onboarding
January 2025
Construction and verification of facility over ~2.5 years
April 2027
IOQ facility completion & permission to use
July 2027
IOQ equipment completion & move-in
October 2027
First clients
