OligoProcess™ Oligonucleotide Synthesizer Product Overview

The OligoProcess™ synthesizer is a high-capacity oligonucleotide production system designed for clinical phase and commercial-scale manufacturing, with a synthesis range from 10 to 1800 mmol. Capable of producing hundreds of kilograms to metric tons of oligonucleotides annually, it ensures cost- and time-efficient production while maintaining high quality and regulatory compliance.

• Broad Production Scale: Supports large-scale oligonucleotide synthesis, making it suitable for clinical trials and commercial manufacturing.
• Seamless Scale-Up: Designed for smooth transition from ÄKTA oligosynt™ and ÄKTA OligoPilot™, ensuring a consistent and scalable workflow.
• Regulatory Compliance: UNICORN™ software enables data integrity and compliance with US FDA 21 CFR Part 11, supporting GMP requirements.
• Reliable & Proven Design: Verified by leading therapeutic oligonucleotide manufacturers, it incorporates industrial-grade components and flow-through column technology from the ÄKTA oligopilot plus and OligoPilot 400.
• Flexible Production Planning: The system’s capacity is optimized based on production schedules and instrument utilization, making it adaptable for both multipurpose and single-product facilities.
• Comprehensive Support: Provides Installation and Operation Qualification (IQ/OQ) documentation and performance support, ensuring reliability and efficiency.

The UNICORN™ software streamlines method transfer between production sites and integrates with chromatography and filtration processes, making OligoProcess™ an ideal solution for high-scale, efficient, and compliant oligonucleotide manufacturing.