Technology
Quality at Oligo Factory
The core of our custom oligo solutions
Quality Principles
Complying with applicable customer, quality, safety, and environmental requirements
Monitoring our customers’ satisfaction levels and taking appropriate actions for improvement
Continual improvement of our processes, people, and systems by establishing and reviewing Quality Objectives and maintain the effectiveness of the quality management system.
Overview
Quality is at our core
Our commitment to comprehensive and compliant quality assurance, exceptional quality control and adherence to stringent global regulatory standards is a foundational element to enable us to deliver high-quality oligos to accelerate the development of therapeutics, diagnostics and life science platforms and tools. Our Quality Management System (QMS) aligns our manufacturing operations with ISO 9001 and ISO 13485 certifications and ICH Q7 GMP guidelines, which includes enhanced documentation and traceability practices, rigorous employee training program, regular audits, and continuous improvement initiatives.
Quality Assurance
Device Master Records
Control of Documents
Control of Records
Certificate of Analysis
Supply Chain Management and Material Traceability for Critical Raw Materials
Commercial Contracts (Non-disclosure, Material Transfer, Supply Agreements, Supplier Quality Agreements including Change Notification managed by Quality Assurance)
Corrective and Preventative Actions (CAPA)
Installation Qualification, Operational Qualification and Process Qualification (IQ/OQ/PQ) programs for instrumentation
Quality Control
Closed-system single oligonucleotide synthesis platform
Sequence Identity Verification by Mass Spectrometry (Molecular Weight confirmation)
Validated Laboratory Information Management System (LIMS) – Waters NuGenesis LMS
Purity Verification by Analytical HPLC – Ion Pairing Reverse Phase (IPRP) or Anion Exchange high-performance liquid chromatography
Quantification by UV Spectroscopy
Lyophilization by calibrated Labconco lyophilizers
