"Solid-Phase Peptide Synthesis (SPPS) is well established and routinely applied on efficient automatic synthesisers, which are available at laboratory scale. However, manufacturing peptides at industrial scale remains a major challenge, considering the complexity of these multi-step syntheses, the long lead times and the large volume of reagents and solvents required to produce the final API. In 2013, we published an article looking at the way to overcome these challenges from a holistic point of view. This article presents the latest practices contributing to making the ideal peptide plant become a reality.
The main challenge of the coming decade will be to cope with the growing demand for peptide manufacturing in an acceptable way. The design of manufacturing processes also needs to take into account the evolution of the ecological factor (waste reduction, green solvent use and technology) of and the economic pressure on drug products. Typically, procedures for industrial SPPS are scaled up directly from the laboratory process: the reactor size is increased and it is operated mostly manually.
To address these challenges, Polypeptide Laboratories is running a programme called Advanced SPPS. This is based on a process engineering approach along several axes: improving the process development methodology to obtain a fundamental understanding of SPPS and develop predictive tools; and improving the manufacturing technology by developing advanced control solutions and fully automating operations [...]"
Read the full article online in Specialty Chemicals Magazine or download the PDF below.
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