Swedish Biomimetics 3000 Ltd (SB 3000), a UK-based company, has invented a new approach to manufacturing of therapeutic peptides that could replace traditional, large-scale batch manufacturing. The µLOT technology platform, which addresses the upstream part of the peptide manufacturing process, is expected to lower the cost of peptide development as well as create a paradigm shift in manufacturing. The continuous process enables in-line process analytical technologies (PAT) to provide improved quality and control and a reduction in cost of goods. It also reduces the use of solvents, which reduces environmental impact. SB 3000 is currently raising a series A round to complete the final leg of the development program.
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,
said Jens Burkinsky, CTO of SB3000.
According to the press release, 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, by running the equipment longer for larger quantities, explains Burkinsky.
The μLOT technology platform uses a ribbon made of polymer mesh with sachet pockets containing a solid-phase resin that moves continuously through all the various chemical stages of manufacture. The ribbon is tailored according to the solid-phase resin, sachet size, and the spacing of the sachets to optimize the process. As the ribbon goes through the manufacturing process, there is close monitoring of every sachet so that high quality can be assured through every step in a continuous fashion, unlike the batch process in which quality is tested at the end, according to the company.
The company says that the ribbon-based platform can be adapted to any solid-phase resin and the modules can be used with any solvent, thus enabling the technology platform to be used for any chemical manufacturing process depending on the separation of a solid and a liquid phase. One example of another process where it could be used is chromatography for purification of therapeutic proteins, including antibodies.