μLOT® is an entirely new approach to manufacturing of therapeutic peptides, which promises to completely replace traditional large scale batch manufacturing.
μLOT® is an entirely new approach to manufacturing of therapeutic peptides, which promises to completely replace traditional large scale batch manufacturing. The µLOT® technology platform provides true continuous manufacturing of peptides enabling in-line process analytical technologies (PAT) throughout the process providing an unprecedented level of quality and control and a significant reduction in cost of goods.
Peptide based medicines are widely used across many therapeutic areas including cancer, diabetes and autoimmune diseases due to their broader therapeutic window when compared to small molecule drugs. The market for peptide medications is projected to rise to $46 billion by 2025.
Developed by UK company Swedish Biomimetics 3000 Ltd (SB 3000) the technology could not only unleash currently not pursued peptide development by significantly lowering the cost, speed up the development of new therapeutic peptides and introduce new important parameters in peptide manufacturing which will result in a paradigm shift improving quality control, cost of goods and environmental impact.
SB 3000 Ltd, founded by Swedish serial entrepreneur Lars Uno Larson, who also founded a rare disease company -now called SOBI- is addressing the upstream part of the peptide manufacturing process which represents ~75% of the total production costs.
Jens Burkinsky, CTO of SB3000 Ltd outlined the benefits, “We believe that the μLOT® process can not only speed up development and reduce cost but also enable the synthesis of drugs that are currently not economically or technically possible to produce. At present we project the μLOT® process being applied to 80 % of the market but are further developing the technology to cover the remaining market by also including novel peptide designs such as lipid- and antibody-conjugations used in modern peptide drug delivery concepts..”
Because all peptides are presently produced through batch manufacturing which is not scalable there is a considerable risk of failure and delay in increasing the size of the batch process from early to late stage development and later to commercial scale. The μLOT® process does not require scale up as the same equipment can be used for manufacture from pre-clinical through to commercial quantities --“all development work is done at commercial scale we just run the equipment longer for larger quantities” says Jens.
The μLOT® technology platform is a “chemical assembly line” which uses a ribbon made of polymer mesh that has sachet pockets containing a solid-phase resin and moves continuously through all the various chemical stages of manufacture – all manufacturing stages are on-going at the same time. The ribbon is tailored according to the solid-phase resin, sachet size and the spacing of the sachets to optimise the process. As the ribbon goes through the manufacturing process there is very close monitoring of every sachet so that high quality can be assured through every single step in a continuous fashion. In contrast, batch manufacturing can never guarantee the quality of every part of the batch and if there is a quality issue the whole batch has to be discarded. This can have serious consequences such as considerable delay in triggering clinical trials; very costly both in potential loss of a batch but more significantly, in terms of cost for disposal of toxic waste. μLOT® is a “green technology, dramatically reducing the use of toxic solvents which in the batch process cost, billions of dollars a year.
SB 3000 is currently raising a series A round to complete the final leg of the development program.
The µLOT® technology platform.
The µLOT® is not just a system for continuous manufacturing of peptides. It is a technology platform where the ribbon can be adapted to any solid-phase resin and the µLOT® modules to any solvent enabling the technology platform to disrupt any chemical manufacturing process depending on the separation of a solid and a liquid phase. One such example, of several, is chromatography required for purification of therapeutic proteins incl. antibodies.
