AST has announced the installation of a next-generation GENiSYS® C fill-finish system at Ascend Advanced Therapies' facility in Alachua, Florida.

Ascend's facility, which spans 58,500 square feet, is located in a rapidly growing biotech hub known for AAV gene therapy.

The GENiSYS C is a fourth-generation fill-finish system designed to comply with the latest EU Annex 1 regulations for sterile products.

This fully automated system can process various commercial and custom containers, significantly reducing operator interaction through automated processes.

Offering rapid 60-minute cycle times, the system utilizes pre-sterilized, ready-to-use containers with robotic handling to enhance efficiency and product quality.

Incorporating a zero-waste processing approach, the system includes in-process weight checks and end-of-batch filling to minimize product loss.

The system features American-built isolator barrier technology developed in partnership with Germfree, along with bio-decontamination technology from CURIS System.

AST's CEO, Joe Hoff, emphasized the partnership's commitment to delivering innovative solutions and maintaining high standards of product integrity.

Ascend's CEO, Mike Stella, highlighted the importance of investment in technology and the customization capabilities provided by the GENiSYS C system.

This new system enhances Ascend's GMP manufacturing capabilities, supporting high-yield, high-quality gene therapy production.

The automated filling system can handle various formats including vials, syringes, and cartridges, ensuring minimal human interaction.

The process is designed to maximize yield while ensuring comprehensive quality checks throughout the production cycle.