Can a new manufacturing technology unlock the next phase of GLP-1 growth?
In our previous blog, we explored a growing challenge facing the peptide therapeutics industry.
Demand for GLP-1 medicines continues to rise, but existing manufacturing technologies are struggling to keep pace. The industry needs a solution that combines capability, scalability and sustainability - without forcing manufacturers into difficult trade-offs.
At Croda, we believe we have the solution, and we now have the data to prove it.
Introducing: GAPP™
Group Assisted Purification Peptide Synthesis (GAPP™) is a next-generation peptide manufacturing technology that has been under development for more than 12 years. Unlike conventional tag-assisted approaches, GAP-PS uses a proprietary solvent anchor to actively control peptide solubility during synthesis.That might sound like a small technical detail, but it addresses one of the biggest barriers in solution-phase peptide manufacturing. By maintaining precise solubility control throughout the process, GAPP™ enables the synthesis of much longer and more complex peptide sequences fully in solution.
At the same time, it supports faster processing, reduced solvent consumption, improved process consistency, and easier scale-up using existing manufacturing infrastructure. The real question, however, is whether it works in practice.
To answer that question, Croda recently completed a study using Tirzepatide, one of the most commercially important and technically demanding GLP-1 therapeutics currently available.
The data speaks for itself
Tirzepatide contains 39 amino acids and presents a significant manufacturing challenge. Using GAPP™, Croda successfully synthesised all four Tirzepatide fragments, demonstrating high yield, high purity, robust solubility control, and encouraging scalability characteristics.
Particularly notable was the successful synthesis of a 14-amino-acid fragment, well beyond the practical capability range of conventional LPPS and many existing TAPS technologies.
The study also highlighted potential sustainability advantages. GAPP™ replaces many solvent-intensive operations with water-based processing. Thus, it can significantly reduce solvent consumption compared with traditional solid-phase synthesis approaches.
Importantly, this work is still at an early stage. Further optimisation is already underway and additional improvements are expected. Even so, the data gathered so far suggests that GAP-PS has the potential to overcome many of the limitations that have historically constrained peptide manufacturing.
As demand for GLP-1 therapies continues to accelerate, innovations in manufacturing will become just as important as innovations in drug discovery.
The peptide therapeutics era has arrived. The technologies used to manufacture these medicines now need to evolve alongside it.
Read the whitepaper to explore the Tirzepatide data and learn how GAPP™ could help solve the peptide API supply challenge.
A new technology to solve, the peptide API supply challenge
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