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Enabling Complex Peptide Manufacturing

Experts at Grace specialize in manufacturing customized functional and novel amino acids 

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About 7% of the new drugs approved by the US Food and Drug Administration between 2015 and 2019 were peptides or peptide-containing molecules. Peptides are also being explored for biomedical applications as a drug delivery system and a base for new biomaterials.  

Working with a partner that understands amino acid chemistry and has experience scaling the production of functionalized peptide building blocks are important considerations for successfully producing these specialized compounds to meet a program’s demand from initial clinical development through commercialization.

Peptides are challenging molecules to synthesize. They can be synthesized from natural amino acids, novel non-natural amino acids, or a combination thereof. The enantiomeric purity and overall purity profiles of the amino acid building blocks can have a great impact on the purity of the final peptide. Therefore, the manufacturing processes for functionalized or novel non-natural amino acids must be well understood and carefully controlled to ensure the final drug substance will meet the product specification requirements. It is important to understand both the formation and methods of detection for key impurities that might be difficult to detect. Controlling and monitoring for byproducts such as β-alanine insertion dipeptides, maintaining high chiral purity, and side reactions in functionalized molecules are some of the challenges that must be overcome. Not doing so can affect throughput and result in costly purification to meet the quality requirements for the finished peptide.

Peptides by design

At Grace’s Fine Chemical Manufacturing Services (Grace’s FCMS), highly trained chemists, engineers, and process experts help clients navigate the complexities of amino acid chemistry from concept to commercialization. Combined with the company’s extensive analytical and purification services, customers receive high-quality customized functional and novel amino acids.

Grace’s FCMS produces functionalized natural amino acids, as well as novel synthetic amino acids with unique structures, such as pseudoproline dipeptides, alpha-methyl amino acids and non-natural derivatives of phenyl-, naphthyl- and pyridylalanine, to name just a few. Synthetic amino acids can add unique characteristics, opening virtually limitless possibilities for peptide drug development.

At Grace’s FCMS, research and development of novel amino acid and peptide synthesis supporting technologies at the laboratory scale is integrated with process development through scale-up under current good manufacturing practices (cGMP) to meet global regulatory requirements. 

“We chose to work with Grace for the production of our novel, non-natural amino building blocks because we wanted a trusted partner that understood complex amino acid chemistry,” said Allen Annis, Ph.D., Senior Vice President of Research at Aileron Therapeutics. “Working with Grace, we have been able to scale from the R&D bench to the manufacturing plant to produce key peptide building blocks for our clinical program.” 

Contact us to learn more about working with Grace’s FCMS to support custom peptide drug development.

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