By Richard Hammond, chief technical officer at Sphere Fluidics
Single-cell microfluidic-based strategies proceed to be a key enabling know-how for cell engineering as they permit true single-cell degree working, with the related precision of measurement and management of atmosphere, and a excessive degree of automation, enabling the pace and scale essential to course of and search massive populations.
Single-cell approaches began over a decade in the past with analysis into single-cell gene evaluation and the creation of core assay, fluidic and optical strategies to profile single cells on the genomic, proteomic, and phenotypic ranges. The primary business merchandise appeared within the mid 2010s, bringing rising ranges of automation and ease of use to single-cell evaluation strategies.
Firms akin to RainDance, 10X Genomics, Sphere Fluidics, Berkeley Lights and Mission Bio had been on the forefront of this new method.
The previous couple of years has seen the sphere lengthen in two fascinating instructions.
From analysis to growth and manufacture – and from cell line to ATMP
Because the know-how and instruments have matured, single cell strategies have moved from being analysis instruments to a core know-how supporting growth and manufacture of therapeutics. Excessive-throughput single-cell methods at the moment are used to establish and isolate particular cell strains with desired traits in functions, akin to antibody discovery. Over the previous couple of years, this has been additional pushed by adjustments in regulation; specializing in provenance of cell strains used for manufacture and demonstrating monoclonality.
The power supplied by single-cell microfluidics to supply traceability of a cell line again to true single clone has additional pushed their adoption past analysis.
Throughout 2022, this pattern into manufacture continued, for instance making use of single-cell evaluation into high quality management for cell remedy merchandise, significantly crucial high quality attributes akin to vector copy quantity which wants cell-by-cell quantification.
Additionally it is fascinating to notice the applying of the know-how into superior remedy medicinal merchandise (ATMPs) the place the cells being dealt with by the microfluidics type the therapeutic dose equipped to the affected person, slightly than part of a producing course of.
In 2023, we are going to see continued utility of the know-how into manufacture and QC, significantly for ATMPs. The bottlenecks in viral vector manufacturing for cell remedy is a selected space the place the information gained utilizing single-cell microfluidics will likely be utilized to scale manufacture.
Making use of single-cell microfluidics for processes akin to transfection and stem-cell differentiation are different areas the place the know-how will likely be more and more utilized into cell and gene therapies.
Past mammalian cells
Single-cell microfluidics is now beginning to affect biotech past mammalian cells and human well being. The instruments and strategies developed at the moment are being utilized to vegetation and micro-organisms (fungi and micro organism). Specifically, single-cell microfluidics strategies align very nicely with artificial biology approaches, the place organisms are intentionally engineered for a particular phenotype, sometimes elevated expression of high-value enzymes and metabolites.
In 2023, an space to look at will likely be integration of single-cell microfluidics with non-optical characterization strategies akin to mass spectroscopy and electrical impedance. This can enable real-time identification and choice of particular person cells primarily based on a plethora of latest traits, not simply fluorescence derived from a particular binding occasion.
Richard Hammond is chief technical officer at Sphere Fluidics. He’s chargeable for R&D, managing the event of their science and know-how.