Issue: May / June 2024

Fast Flow peptide synthesis – The route to difficult peptides and scale up

10 June 2024 No Comments

In recent years, fast flow solid-phase peptide synthesis (FF-SPPS) has been embraced by industry as way to quickly synthesise new peptide-based drugs for the discovery space. By applying uniform heating and inhibiting the movement of resin beads, high reaction efficiency is achieved, while also preventing β-sheet structure formation, thereby improving solubility of peptides as they are synthesised.
Using the FF-SPPS approach, protocols have been developed that work for both long peptides and for sequences where the peptides aggregate. These protocols achieve maximum cycle efficiency by flowing reagents in a single pass through the resin.
By way of example the suitability of FF-SPPS is illustrated by the synthesis of a 77-mer α-helical coiled coil peptide, with a synthesis time of under 20 hours and achieving a crude purity of ~62 %.
A further example is discussed for the linear scale up of a GLP-1 analogue where the use of FF-SPPS, results in a 300X scalability factor without further optimisation. The synthesis time for this GLP-1 analogue at 15 mmol scale is 15 hours with and crude purity of ~80 %.

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OLIGONUCLEOTIDES AND PEPTIDES NEWS

10 June 2024 No Comments

This news section features recent discoveries (December 2023 – April 2024) for developing, modifying and delivering therapeutic peptides and oligonucleotides and is divided in categories: discovery, development, delivery, RNA.
The selection was made searching on Google and Pubmed, with the following keywords: peptides news, peptides discovery, peptides development, peptides manufacturing, peptides delivery, oligonucleotides therapy, mRNA.

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Building your bioassay data package

10 June 2024 No Comments

Bioassays are a cornerstone of drug development, providing insight into the mode of action (MoA), potency, and potential immunogenicity of biologic therapeutics. These assays are utilized at various stages from early discovery to clinical trials. However, with so many variations that impact multiple outcomes, selecting the right bioassay is more than a matter of preference – it’s a potential make-or-break moment for a project. As advances in instruments and techniques continue to broaden the bioassay toolbox, this article focuses on what stage appropriate assays can be selected to drive our drug development process forward with increased chance of clinical success.

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Nucleic acid therapeutics through discovery and manufacturing to digitalization

10 June 2024 No Comments

This article explores the dynamic field of nucleic acid therapeutics, highlighting its evolution from targeting specific genetic disorders to addressing multifactorial diseases, incorporating insights from industry experts collected through interviews. It refers to the developmental trajectory of these therapies, including key scientific breakthroughs, advancements in drug delivery systems like GalNAc-siRNA conjugates, and the ongoing challenges in manufacturing scalability and regulatory compliance. Furthermore, the article discusses the integration of digital technologies that enhance the efficiency and effectiveness of research and development processes.

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Digital solutions for advancing your mRNA workflow Paperless manufacturing reduces the documentation burden on small-scale mRNA manufacturing

10 June 2024 No Comments

For emerging mRNA-based drugs that can sometimes require small, intensified batches, paperless manufacturing—using automated, digital data management instead of paper-based recordkeeping—offers even more competitive advantages. In this article, we address the benefits of paperless manufacturing to both small and emerging companies alike, why it’s essential to incorporate a digital strategy early in the manufacturing process, and how a digital solution for mRNA manufacturing can help small batch manufacturers more effectively produce these soon-to-be essential medicines.

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