The facility

Engineered from the ground up for islet cell processing

Every aspect of the facility — from layout and airflow to equipment selection and workflow — was engineered to support highly efficient, reproducible standard operating procedures (SOPs) that maximize islet yield, viability, and safety.

Our customized infrastructure and procedural workflow enables rapid processing of both normal and diseased pancreatic tissue while maintaining strict regulatory compliance and minimizing cold ischemia time.

Facility capabilities

Built for precision, reproducibility, and compliance

Purpose-built cleanroom
Dedicated ISO-classified cleanroom environment designed specifically for clinical cell processing — not repurposed laboratory space.
Optimized airflow & layout
Facility layout and HVAC systems engineered to minimize contamination risk and support unidirectional workflow.
Reproducible SOPs
Standardized operating procedures developed and validated to ensure consistent, reproducible outcomes across every isolation.
Cold ischemia minimization
Workflow and logistics designed to minimize cold ischemia time from procurement through processing and delivery.
Diseased tissue capability
Specialized protocols for processing both normal and diseased pancreatic tissue — including fibrotic tissue common in chronic pancreatitis.
Regulatory infrastructure
Full documentation systems, quality management, and chain of custody protocols aligned with FDA cGTP requirements.
Compliance & standards

Regulatory framework

Our platform is built to meet and exceed the regulatory requirements for clinical cell therapy processing in the United States.

FDA cGTP
Current Good Tissue Practice compliance
ISO
Cleanroom classification standards
SOP
Validated standard operating procedures
QMS
Full quality management system
Clinical impact

What this means for your patients

This platform represents a significant advancement in autologous islet cell therapy, allowing us to deliver consistent, high-quality islet preparations that give patients with chronic pancreatitis and other pancreatic conditions the best possible chance for restored endocrine function and improved quality of life. By combining purpose-built infrastructure with deep procedural expertise, IsleNova delivers islet preparations that maximize transplant viability and long-term outcomes.

Learn more about our capabilities

Interested in partnering with IsleNova for your surgical program? Register your interest or contact us to discuss your program's needs.

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