Contract Manufacturing For Clinical And Pre-Clinical Projects

AssureImmune operates a processing facility that is registered with the FDA as a Human Cell and Tissue Establishment. Product manufacturing is performed in a designated clean room space qualified to maintain an air quality of ISO-Class 7 standard.

Tissue handling and product manufacturing are completed within a certified Class II A2 Biological Safety Cabinet.

All products are carefully analyzed and characterized prior to release by the AssureImmune quality assurance team.

cGMP Compliant

Our processing facility maintains a quality program demonstrating FDA regulatory compliance related to Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/P).

Standard Operating Procedures have been established and maintained to meet core Current Good Manufacturing Practice (cGMP) and Current Good Tissue Practice (cGTP) requirements. Biologics manufacturing is performed and monitored in ISO7 clean room space following cGMP regulation standards.

At AssureImmune, we understand each project is different. Instead of a one-size-fits-all product development plan like other consulting firms offer, AssureImmune tailors plans designed to fit your unique and specific needs.

This includes:

• Process Development & Optimization
• Manufacturing Processes Optimization
• Cell Line Development
• Upstream Development
• Downstream Development
• Formulation Development
• Product & Process Characterization
• Potency Assay Development