Î¼LOT is an entirely new approach to manufacturing therapeutic peptides, which promises to completely replace traditional large-scale batch manufacturing. The µLOT technology provides continuous manufacturing of peptides enabling in-line process analytical technologies (PAT) throughout the process, providing an unprecedented level of quality, control and a significant cost reduction.
Peptide-based medicines are widely used across many therapeutic areas including cancer, diabetes and autoimmune diseases with the market projected to rise to $46 billion by 2025.
Jens Burkinsky, CTO of SB3000 commented, We believe that the Î¼LOT process will speed up development, reduce cost and enable the synthesis of drugs currently not economically or technically possible to produce. At present the process is applicable to 80% of the market. We are developing the technology to cover the remaining market by including novel peptide designs such as lipid- and antibody-conjugations.
Presently all peptides are produced through batch manufacturing which is not scalable. To increase production during development and later for commercial scale involves a considerable risk of failure and delay. The Î¼LOT process does not require scale-up –all development work is done at commercial scale we just run the equipment longer for larger quantities says Jens.
The Î¼LOT platform is a chemical assembly line which uses a ribbon made of polymer mesh with sachet pockets containing a solid-phase resin. This moves continuously through all the chemical stages of manufacture. The ribbon is tailored according to the solid-phase resin, sachet size and spacing of the sachets to optimise the process. Throughout the process there is close monitoring of every sachet so that high quality is assured. In contrast, batch manufacturing can never guarantee the quality of every part of the batch. If there is an issue the whole batch has to be discarded causing delays, financial loss, and significant cost for disposal. Î¼LOT also dramatically reduces the use of toxic solvents costing billions of dollars a year.
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SB 3000 is currently raising a series A round to complete the final leg of the development program.