Introduction
BiologIC, a leading technology company, is revolutionising synthetic biology with their cutting-edge 3D bio-processors. These innovative vessels enable biological reactions and the printing of living tissues using digital blueprints. By integrating fluidics, electronics, thermals, optics, and pneumatics, BiologIC is paving the way for the next generation of synthetic biology at scale. This breakthrough technology finds applications in various fields, including research, diagnostics, cultured meat production, biofuels, and COVID-19 diagnostics and vaccine manufacturing.
Ensuring Product Safety and Compliance
Manufacturers of diagnostic products face regulatory obligations to prevent the migration of harmful substances from production equipment. BiologIC understands the importance of meeting these requirements to safeguard the integrity of their products, protect consumers, and ensure accurate assay results. Identifying and addressing potential leachables from surfaces and containers used in the manufacturing process is crucial.
Partnering with NPL for Measurement and Optimisation
Under the Measurement for Recovery scheme (M4R), BiologIC collaborated with the National Physical Laboratory (NPL) to optimise their 3D bio-processor technologies and fulfill their regulatory obligations. NPL's expertise helped identify and optimise key parameters essential for understanding the performance of the synthetic biology processes.
Advanced Analytical Techniques
NPL employed a range of physical and chemical measurements to gain insights into the performance and potential leachables of BiologIC's processes. Liquid Chromatography Mass Spectrometry (LC-MS) techniques played a central role in this work. LC-MS combines the liquid chromatography's separation capabilities with mass spectrometry's analytical power, providing high sensitivity and selectivity for this type of analysis.
The impact
Through collaboration with NPL, BiologIC achieved significant advancements in their 3D bio-processor technologies. The optimisation of processes, combined with the ability to meet regulatory obligations, positions BiologIC as a leader in synthetic biology applications. With their enhanced digital hardware, they are poised to drive innovations in diagnostics, vaccine production, and other fields, while ensuring safety and compliance in the manufacturing process.
It was impressive to see the high sensitivity of our instrument at work. To detect leachables within minutes of incubation shows the extreme potential of the LC-MS as the leading analytical technique
Andrea Briones - Higher Research Scientist - NPL