Development Services
Customized stem cell process development services to bring your next generation cell therapies from concept into reality.
Process and Analytical Development Services
Stem cell therapies are complex and difficult to translate to the clinic. Many times, promising new cell therapies never make it out of the laboratory. Pluristyx excels at tackling the most challenging aspects of the product lifecycle, effectively accelerating your development efforts to bring life saving products to patients in need.
With our decades of combined industrial experience bringing cell therapies to life, Pluristyx tackles the most challenging aspects of stem cell development, including the analytical methods and quality control necessary to accurately benchmark therapies to ensure they perform as expected from the start.
Working with Pluristyx and utilizing the panCELLa Platform offers you an efficient way to move forward. With a reliable partner by your side, you can concentrate on your specialty while we develop an efficient process for you.
iPSCs with a
clinical path
Phase-appropriate gene editing processes that give you the quality control and confidence to address regulatory scrutiny.
Stable from
the start
Well-characterized and genetically stable cell banks that are an ideal starting point for your downstream stem cell process development.
Enhancing
your process
Improve your iPSC differentiation process and develop analytical tools to better evaluate your product throughout the entire development lifecycle.
Enough cells to treat
the population
Assistance in iPSC manufacturing process scale-up to ensure the cost-effective production of your product is delivered at commercial scale.
iPSCs with a
clinical future
Phase-appropriate gene editing processes that give you the quality control and confidence to address regulatory scrutiny.
Stable from
the start
Well-characterized and genetically stable cell banks that are an ideal starting point for your downstream stem cell process development.
Enhancing
your process
Improve your iPSC differentiation process and develop analytical tools to better evaluate your product throughout the entire development lifecycle.
Enough cells to treat
the population
Assistance in iPSC manufacturing process scale-up to ensure the cost-effective production of your product is delivered at commercial scale.
Our Process for Development Services
1. iPSC Reprogramming
Proprietary Cellular Reprogramming technology provides you with the ability to evaluate and license existing PluriBank clinical grade iPSCs or generate a unique and custom-built cell line from regulatory compliant donors.
2. Cell Line Development and Banking
Genetically-edit and develop uniform and fully characterized cell banks that you can use for research, analytical method development, and drug substance manufacturing.
4. Scale-Up
With economies of scale, you can move from small to large batch suspension-based manufacturing that delivers large numbers of raw material for clinical trials at an optimal price point.
3. Process and Analytical Development
Improve your differentiation process and develop tools that help you better evaluate your cell therapy product throughout the entire pharmaceutical drug development lifecycle.
Development Process
1. iPSC Reprogramming
Proprietary Cellular Reprogramming technology provides you with the ability to evaluate and license existing PluriBank clinical grade iPSCs or generate a unique and custom-built cell line from regulatory compliant donors.
2. Cell Line Development and Banking
Genetically-edit and develop uniform and fully characterized cell banks that you can use for research, analytical method development, and drug substance manufacturing.
3. Process and Analytical Development
Improve your differentiation process and develop tools that help you better evaluate your cell therapy product throughout the entire pharmaceutical drug development lifecycle.
4. Scale-Up
With economies of scale, you can move from small to large batch suspension-based manufacturing that delivers large numbers of raw material for clinical trials at an optimal price point.
Try Before You Buy
Gain access and evaluate our proprietary modified and non-modified iPSCs with smaller upfront costs and lower risk using our Research Evaluation Agreement. Once you see the successful results, you can confidently enter into a license agreement with us that will take you through your cell therapy clinical trials.
