Manufacturer Refeyn has unveiled its latest innovation, a software package designed to expand the use of the Samux and Samux Auto mass photometers in GMP-regulated environments.
The Samux range is optimised for AAV analytics and provides rapid and accurate measurements of empty:full AAV ratios with minimal sample required. The new software now enables the implementation of mass photometry within AAV-based gene therapy manufacturing facilities while adhering to the strict regulatory requirements of FDA 21 CFR 11 and EMA Annex 11.
As well as these FDA and EMA regulations, utilising the speed and simplicity of Samux mass photometers for AAV characterisation in GMP-regulated environments depends on meeting the specific requirements for instrument and process validation. The newly launched software package includes three different applications: Acquire, Evaluate, and Manage.
These applications offer user access control, audit trails, standardised workflows, and electronic signatures for streamlined and controlled AAV analytics in manufacturing environments. This provides compliance to regulations around data traceability and integrity during acquisition, analysis, and export.
Our new software ensures easy and secure operation and administration, enabling manufacturers to uphold the highest standards of quality
- Matthias Langhorst, Chief Product Officer at Refeyn
"Refeyn's new software package for GMP enables the seamless integration of mass photometry into AAV manufacturing processes, unlocking the efficiency that SamuxMP instruments bring to AAV analytical workflows," said Matthias Langhorst, Chief Product Officer at Refeyn. "Our new software ensures easy and secure operation and administration, enabling manufacturers to uphold the highest standards of quality throughout their operations."
As the sole manufacturer of mass photometry instruments and technology worldwide, Refeyn leads the industry with its innovative solutions. Mass photometry excels in terms of speed, ease of use, cost-effectiveness, and high-precision molecular mass measurements at the single-molecule level.
With the introduction of this software package, mass photometry is readily available for AAV sample characterisation in manufacturing environments, providing unparalleled insights and accelerating the development of AAV-based gene therapies.
Refeyn remains committed to pushing the boundaries of mass photometry and supporting the biopharmaceutical industry to achieve groundbreaking advancements in AAV-based gene therapies. With the Samux software package for GMP-regulated environments, Refeyn continues to pave the way for efficient and high-quality manufacturing processes, ultimately improving patient outcomes.