Breaking New Ground: Parimer Scientists Pioneer a USP Grade Excipient for the Market

Background

Iterro has developed a proprietary and novel manufacturing process to produce some of the world's finest shrimp using a controlled process and complete chain of custody. Each crop of shrimp is collected at the same age, with the same species, at the same temperature, year-round.

This unique source of crustation tissue allowed for the opportunity to produce the most consistent and high-quality pharmaceutical-grade chitosan on the market. The Iterro team contacted Parimer to help take advantage of this unique opportunity

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The Challenge

The shells produced from the shrimp natively contain no chitosan but instead a polysaccharide precursor, organic tissue residue, inorganic material, and other impurities that may not conform to tight pharma regulations. Iterro needed a partner who could solve the contamination problem and offer a scalable, consistent solution. 

The challenge before Parimer, was to take this highly controlled shell tissue and discover how to convert it to the world's finest chitosan meeting the strictest of United States Pharmacopeia requirements.  

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The Solution

The Parimer team started with published scientific methods to produce the chitosan and established a baseline process to yield typical quality chitosan. Parimer added new process controls to meet FDA cGMP compliances, including method development for analytical testing and process controls. 

The R&D team at Parimer utilized both iterative approaches and surface response modeling experimental design approaches to meet all 27 quality control parameters for this product line.

The final product solution has raised the bar for the production of USP-grade chitosan with undetectable levels of several key impurities found in many chitosan which have been a barrier to wide industry adoption.  

Looking Ahead

With this groundbreaking solution, Iterro is now positioned to offer USP-grade chitosan products with quality and compliance with the support of Parimer. Scaling production and refining product offerings promise significant advancements in chitosan applications across industries.