Nucleic Acids for Diagnostics
The utilization of nucleic acids in the diagnosis of a wide array of acute and chronic diseases is on the rise. In oncology, for instance, nucleic acids are used in early cancer detection as well as in tumor identification and classification. The acclaimed attributes of nucleic acids, characterized by their stability and ability to interact with targets with high affinity and specificity, underscore their significance. The morphological features of nucleic acids find applications in forensics, particularly DNA fingerprinting.
BioSpring manufactures nucleic acids for commercial diagnostic applications such as forensics, and HLA-typing, in addition to supporting early-stage research and development projects. We offer manufacturing compliant with ISO 13485, ISO 9001 and according to FDA 21 CFR Part 820.
Our scope of services includes:
- Commercial diagnostic manufacturing experience
- Comprehensive analytical methods
- Broad range of modifications
- Implementation of manufacturing processes in close collaboration with the client
- Creation of individual production protocols (batch records)
- Proven processes to avoid human DNA contamination and cross-contamination
- Established solutions for complex forensic applications
- Adaptation of work processes to meet specific requirements
Production Facility
State-of-the-art facility dedicated to nucleic acid diagnostic production for commercial supply and development.
- Separate and dedicated workspaces
- Highly qualified personnel
- Qualified manufacturing equipment and suppliers
- Test equipment monitoring
- Dedicated columns for individual HPLC purification
- Full traceability of raw materials and process steps
Systems and Processes
- Supplier Qualification System
- Controlled document system (ALCOA+)
- Deviation System
- Change Control System
- CAPA System
