GMP Clean Room
Oligo and enzyme formulation, aliquoting and final packaging at Class C / Class D clean-room standards. A positive-pressure, HEPA-filtered flow design that prevents cross-contamination.
Production Facility
ANT Biyoteknoloji designs, validates and manufactures molecular diagnostic kits with GMP clean-room production, a BSL-2 laboratory, an R&D centre and an ISO 13485 quality system.
From design to validation and from production to quality control, every stage is carried out at a single facility. This guarantees the reproducibility of the kit chemistry and the integrity of the supply chain.
Oligo and enzyme formulation, aliquoting and final packaging at Class C / Class D clean-room standards. A positive-pressure, HEPA-filtered flow design that prevents cross-contamination.
Production Facility
A laboratory designed in accordance with WHO Laboratory Biosafety Manual level 2 conditions for working with pathogenic clinical samples — Class II biosafety cabinets, HEPA filtration, controlled airflow. Validation, external quality control and cross-reactivity studies are conducted here.
Validation
Multiplex panel design, probe/primer optimisation and sigmoid algorithm development. The software R&D team (UMS) works alongside the chemistry R&D team (Uniqplex).
R&D
Documented processes compliant with the medical device quality management system standard (ISO 13485). Supplier management, design verification, risk analysis and vigilance — all under a single system.
Quality
Our kit family (EU) 2017/746 IVDR conformity assessment process. SGS Belgium NV (Notified Body NB 1639), with whom a written agreement has been signed in accordance with IVDR Annex VII Section 4.3; the formal application has been completed.
Our production system ISO 13485 complies with the medical device quality management system. Existing kits are CE-IVD marked under the IVDD and TİTCK registered.
(EU) 2024/1860 transition dates under the transition provisions: Class B kits 31 December 2029, Class C kits 31 December 2028. Kit supply and clinical use continue without interruption.
Notified Body Confirmation Letter · CLNB1639 · 30 March 2026
In our R&D cycle, kit chemistry, the UMS analysis software and clinical validation advance within the same team. When a new kit family is designed, multiplex probe design, threshold algorithms and the clinician report take shape simultaneously — all three emerging from a single development cycle.
This approach allows pilot-lab feedback to feed directly back into the kit chemistry. Threshold values, curve quality, false-result patterns — all are measured through UMS and incorporated into the next kit revision.