Cell Therapies Can Revolutionize Treatment, Automation Needed to Scale Production – ENGINEERING.com

Parker Hannifin has sponsored this post.

Cell therapies promise treatments for serious illnesses, but require automation and manufacturing expertise to scale up production for research and products. (Image courtesy of Parker Hannifin.)

Cellular therapies and bio-fabrication are two of the most revolutionary treatments for serious illnesses to be developed in the early 21st century, offering the hope of cures where once only symptomatic treatments were available. The 2006 discovery of Induced Pluripotent Stem Cells (iPSCs) formed a catalyst for research and development into these new therapeutic approaches. Stem cell therapies offer promising avenues for the treatment of devastating illnesses such as diabetes, cancer, heart disease and even neurological diseases.

Tailored cell therapies using iPSCs are considered to be the new Third Pillar of the drug and treatment industry, standing alongside small molecules and biologics as tools for treatment. However, the widespread research and treatment using cell therapies requires mass-produced iPSCs to be available in quantitywhich means advanced manufacturing techniques.

Cells are tiny living, complex organisms; they must be handled with precision and accuracy. Automated handling equipment needs a heightened level of dexterity and control. (Image courtesy of Parker Hannifin.)

Scaling up the production of iPSCs requires investmentsome of which is already in place with two deals: $70 million to the New Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to advance U.S. leadership in the biopharmaceutical industry, and an 87-member coalition funded by the Defense Department called ARMI-BioFab USA, which aims to develop the next-generation techniques needed to repair and replace cells, tissues and organs for wounded military service veterans.

The key to success in the scale-up of production is advanced automation, which will improve the manufacturing process used to fabricate cell colonies.

Currently, most research and cell fabrication involves a significant amount of manual work and decision-making, which can be error-prone and represents a bottleneck in attempts to scale these fabrication processes.

One way to improve the manufacturing processes related to cell therapies is by partnering with experienced automation and manufacturing industry leaders, who can share their expertise. An example of this is the partnership between Parker Hannifin and CellX Technologies. Together, these companies have developed a platform to help researchers and clinicians quantify key morphological stem cells, automate the handling process and perform cell maintenance.

Current cell therapy research is hampered by difficulties with a lack of large field-of-view and high-resolution optics when imaging live cell cultures. This makes it difficult to monitor and quantify changes to the cells. Available devices and equipment for sampling, transfer or deletion of specific cells or colonies also lack the rigorous accuracy that manufacturing-scale production would require. Instead, visual assessment and manual transfer by lab technicians is the usual methodsacrificing speed and production volume.

An automated, image-based system would enable accurate quantitative metrics of biological performance and will be applicable at a cell-by-cell or a colony-by-colony basis, among other benefits.

Automated cell-handling equipment needs to be precise and finely calibrated in order to handle delicate cells with the necessary dexterity and control. Three primary handling techniques are used for this very difficult automation task:

Combining capabilities for these three functions into a single platform will enable multiple benefits, including improved reproducibility and quality of cells for research and products, reduce variability and costs from manual processes, improved lot traceability and documentation, and define quantitative process quality attributes and metrics.

Parker Hannifins expertise in manufacturability, digital pathology and additive manufacturing lends itself directly to the development of the CellX platform. CellX enables automation of the scanning and identification processes, and pairs this with cell selection and precision placement.

The CellX Device, developed by Parker Hannifin and CellX Technologies, combines large field-of-view imaging with precision instrumentation, fluidics, and documentation and control capabilities. (Image courtesy of Parker Hannifin.)

CellX also needed customization of standard products. Parker Hannifin has decades of experience in close tolerance special purpose fluidics and actuator technology, and developed enabling technology for the CellX central core, which consists of a high-quality automated inverted microscope and CCD camera with brightfield and fluorescent imaging capabilities.

Some of the specialized equipment that Parker Hannifin helped develop for CellX includes a load and removal station for disposable cell-picking tips, and environmentally controlled workspace to maintain sterility and oxygen levels, and an integrated sensor to accurately locate each new tip.

The combined precision and imaging capabilities of the CellX platform enable rapid data collection and high repeatability, which means researchers can rely on accurate data, healthy cell colonies and quantitative, reproducible standards for cell therapy development. Parker Hannifin has a proven history of developing new tools and instruments for manufacturing processes with their partner OEMsand in the case of CellX, accelerating the development of the future of cell therapies.

To learn more about Parker Hannifins development of the CellX platform, including use cases and details on the full complement of customized equipment and enabling features, download the full whitepaper from Parker Hannifin.

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Cell Therapies Can Revolutionize Treatment, Automation Needed to Scale Production - ENGINEERING.com