Onco-Innovations begins nanoparticle work with Dalton

Executive Summary

• Onco-Innovations Ltd. has commenced manufacturing activities with Dalton Pharma Services to produce its proprietary nanoparticle formulation (PEO-b-PBz-CL), a key component of its novel drug delivery platform.
• The initiative focuses on process optimization and scale-up to support preclinical animal studies and generate data for regulatory filings.
• The production campaign aims to transition from initial feasibility at the 10-gram scale to a 350-gram demonstration batch, ensuring quality specifications are met for future Good Manufacturing Practice (GMP) manufacturing.

Key Details

• Partnership: Onco-Innovations is working with Dalton Pharma Services, a Canadian contract development and manufacturing organization, to manufacture the proprietary nanoparticle formulation known as PEO-b-PBz-CL.
• Purpose: The manufacturing is intended to generate material for preclinical studies and provide analytical data to support regulatory filings and the transition to GMP manufacturing.
• Scale-Up Plan:
  • Dalton has already demonstrated initial feasibility at the 10-gram scale.
  • Current focus is on reducing residual catalyst content.
  • Production will scale to 100 grams.
  • A demonstration batch will be produced at the 350-gram scale.
• Quality Specifications: The process optimization ensures the formulation meets specific requirements for purity, molecular weight, and residual solvent levels.
• Deliverables: Dalton will provide a comprehensive development package, including full analytical characterization and process documentation, to facilitate clinical readiness.

Notable Quotes

• "Advancing the nanoparticle formulation demonstrates will help inform our next phase of development, advancing our pathway toward the clinical opportunities we are determined to reach," stated Thomas O'Shaughnessy, chief executive officer of Onco-Innovations.