Grades of manufacture, standards, documentation and traceability.
Research grade material available now, with GMP grade capability in build, backed by documentation and traceability.
Built for regulated work.
Trust in a nucleic acid program rests on the integrity of its material and its data. Syngenis operates within established quality frameworks and applies them with the discipline that regulated development demands, so a program is prepared for regulated pathways from the outset.
Grades of manufacture.
- GLP research grade, operational now, for research, diagnostics and early development.
- GMP clinical-grade manufacturing capability targeted operational from January 2027.
Standards we work to.
- TGA (Australia), FDA (United States) and EMA (European Union) regulatory requirements.
- ICH Good Clinical Practice for clinical programs.
- ISO 13485 and medical device standards for diagnostic programs.
- Established quality systems, validated data capture and full traceability aligned with research grade and GMP manufacturing.
Documentation and traceability.
We maintain project records, batch records and contemporaneous documentation across every program, supporting client compliance needs, R&D Tax Incentive claims and any regulatory or agency review. GMP manufacturing requires higher standards of quality control, documentation, traceability and oversight than research grade supply, and the facility has been designed for exactly that.
Onshore, sovereign material integrity.
Because Syngenis manufactures and characterises the material it studies, the clinical supply, its analytical characterisation and the study that uses it are aligned within a single quality framework. This reduces revalidation, shortens supply chains and removes the risks that come with handing material between unrelated parties across borders.
Ready to work with an integrated life sciences company?
Talk to our team about your program, from candidate design to trial ready material.