Engineered for Safe Drug Delivery
ViaCyte engineered the Encaptra® drug delivery system to enable implanted PEC-01™ cells to survive in vivo and to differentiate into functional insulin-producing cells.
The Encaptra device represents an innovation which is considered critical to the production of a safe and effective therapy.
Device Engineering and Manufacturing Overview
The Device Engineering program at ViaCyte is focused on delivering innovative cell encapsulation technologies that meet the highest standards of quality, safety and function for use in modern cell therapy combination products. ViaCyte’s rigorous product development process includes key elements of successful medical device development, including risk management, concept and feasibility assessment, design controls and design and process validation/verification phases. The company’s experienced team of engineers utilizes state of the art engineering tools, such as computational modeling, illustrated below, to ensure that only the most robust designs progress to prototyping and ultimately production. Manufacturing of finished designs is done following the principles of Lean Six Sigma in a certified clean room environment.
Program components include:
- A quality system designed for compliance with US QSR’s and ISO 13485
- Implant grade raw materials tested in compliance with ISO 10993
- Risk management of device development per ISO 14971
- Rigorous in vitro mechanical testing, computational modeling and in vivo functional testing of device designs to demonstrate compliance with specifications and intended use
- Lean manufacturing in a Class 7 clean room
- All designs compatible with the combination product loading system designed by ViaCyte
Encaptra® Drug Delivery System
Applying its expertise in medical device engineering, ViaCyte developed the Encaptra drug delivery system. The Encaptra device is manufactured from implant-grade materials specifically selected for long term biocompatibility. While the Encaptra device was designed for delivery of PEC-01 cells, it is suitable for use with other therapeutic agents. Indicated for subcutaneous implantation, the Encaptra device promotes an effective growth environment for PEC-01 cells while providing complete containment. The Encaptra device is expected to:
- provide 100% encapsulation of PEC-01 cells or other therapeutic agent
- protect allogeneic (transplanted) cells from patient’s alloimmunity and autoimmunity
- allow oxygen, nutrients, and proteins (insulin) to freely transport through the system’s membrane
- remain biocompatible and biostable
- be accessible for monitoring with common clinical imaging systems
- allow for easy retrieval.