Peptide Synthesis Research, CEM Corporation, 3100 Smith Farm Rd, Matthews, NC, 28104, USA.
Nat Commun. 2023 Dec 9;14(1):8168. doi: 10.1038/s41467-023-44074-5.
We present a process for solid phase peptide synthesis (SPPS) that completely eliminates all solvent intensive washing steps during each amino acid addition cycle. A key breakthrough is the removal of a volatile Fmoc deprotection base through bulk evaporation at elevated temperature while preventing condensation on the vessel surfaces with a directed headspace gas flushing. This process was demonstrated at both research and production scales without any impact on product quality and when applied to a variety of challenging sequences (up to 89 amino acids in length). The overall result is an extremely fast, high purity, scalable process with a massive waste reduction (up to 95%) while only requiring 10-15% of the standard amount of base used. This transformation of SPPS represents a step-change in peptide manufacturing process efficiency, and should encourage expanded access to peptide-based therapeutics.
我们提出了一种固相肽合成(SPPS)的方法,该方法在每个氨基酸添加循环中完全消除了所有溶剂密集型洗涤步骤。一个关键的突破是通过在高温下进行大量蒸发去除挥发性 Fmoc 脱保护碱,同时通过定向的顶部空间气体吹扫防止在容器表面上冷凝。该工艺在研究和生产规模上均得到了验证,对产品质量没有任何影响,并且适用于各种具有挑战性的序列(最长达 89 个氨基酸)。总的来说,这是一个非常快速、高纯度、可扩展的工艺,具有巨大的废物减少(高达 95%),同时仅需要标准碱用量的 10-15%。SPPS 的这种转变代表了肽制造工艺效率的重大变革,应该鼓励扩大肽类治疗药物的应用。