Alpha Teknova, a leading manufacturer of critical reagents for life sciences, and Pluristyx, a provider of induced Pluripotent Stem Cells (iPSCs) and related technologies, have announced a collaboration to produce and commercialize Pluristyx's PluriFreeze product line. The partnership aims to address key challenges in the development and manufacturing of next-generation allogeneic cell therapies.
The collaboration will make Teknova the exclusive manufacturer and distributor of the PluriFreeze cryopreservation system in the United States and Canada, leveraging Teknova's extensive manufacturing capabilities and established customer base of over 3,000 life sciences organizations.
Addressing Critical Biopreservation Challenges
Through their work developing iPSCs, Pluristyx identified significant challenges in cellular biopreservation across the cell therapy workflow. This led to the development of a novel cryopreservation formulation specifically designed for the systematic freezing of cells, which streamlines the manufacturing process for cell therapy products.
The PluriFreeze product line consists of two key components: a protective wash and a cryopreservative. This system is specifically designed to simplify the scale-up process for companies working to bring allogeneic cell therapies to market, addressing a critical bottleneck in the cell therapy development pipeline.
"We're excited to announce our collaboration with Pluristyx, a true innovator in the development and commercialization of revolutionary cellular therapies," said Stephen Gunstream, Teknova's President and Chief Executive Officer. "By coming together, we're able to marry Teknova's operational and commercial scale with their novel cryopreservation solution. Getting the PluriFreeze products into our customers' hands will help them streamline the manufacture of allogeneic cell therapies as they move from research, to process development, and into clinical manufacturing."
Technical Specifications of the PluriFreeze System
The PluriFreeze cryopreservation system is entirely synthetic and animal-origin-free, making it suitable for clinical applications. The system includes:
- PluriFreeze Base: A protective wash that mimics intracellular space and provides end-to-end metabolic support
- PluriFreeze PF10: A low viscosity freezing medium containing 10% dimethyl sulfoxide (DMSO) that simplifies scale-up and process automation
Benjamin Fryer, Chief Executive Officer of Pluristyx, emphasized the importance of the partnership: "With almost 30 years of experience manufacturing high-quality research- and GMP-grade reagents and an established base of more than 3,000 life sciences customers, Teknova is the perfect partner to help us expand access to our proprietary PluriFreeze cryopreservation system. As cell therapy developers focus on scaling their solutions into the clinic, it's critical to use a trusted and scalable supply of products that ensure high cellular viability and function at multiple holding points across the workflow – not only during storage and transport."
Implications for Allogeneic Cell Therapy Development
The collaboration addresses a significant challenge in the cell therapy field. Allogeneic cell therapies, which use cells from donors rather than the patient's own cells, offer the potential for off-the-shelf treatments that could be more accessible and cost-effective than autologous approaches. However, manufacturing these therapies at scale requires robust cryopreservation methods to maintain cell viability and functionality throughout production, storage, and transport.
The PluriFreeze system aims to provide a standardized solution that can be integrated across the development pipeline, potentially accelerating the path to clinical trials and commercialization for numerous cell therapy candidates.
Commercial Availability
More information about the collaboration and the products, including pricing and availability, will be announced at the upcoming BioProcess International West conference in San Diego, California, starting on March 19, 2025. This event will provide an opportunity for cell therapy developers to learn more about how the PluriFreeze system could be integrated into their manufacturing processes.
The partnership represents a significant step forward in addressing the technical challenges of cell therapy manufacturing, potentially helping to bring the next generation of cellular therapies to patients more efficiently.
