GMP Cleanroom
Class C / Class D cleanroom standards for oligo and enzyme formulation, aliquoting and final packaging. Positive pressure, HEPA-filtered, cross-contamination preventing flow design.
Manufacturing
ANT Biotech designs, validates and manufactures molecular diagnostic kits within a single facility integrating GMP cleanroom production, BSL-2 laboratory, R&D centre and an ISO 13485 quality system.
From design through validation, from manufacturing through quality control — every stage is executed in a single facility. This guarantees reproducibility of the kit chemistry and the integrity of the supply chain.
Class C / Class D cleanroom standards for oligo and enzyme formulation, aliquoting and final packaging. Positive pressure, HEPA-filtered, cross-contamination preventing flow design.
Manufacturing
Designed to 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 performed here.
Validation
Multiplex panel design, probe/primer optimisation, sigmoid algorithm development. The software R&D team (UMS) and the chemistry R&D team (Uniqplex) work side by side.
R&D
Medical device quality management system documented to ISO 13485. Supplier management, design verification, risk analysis and vigilance — under one system.
Quality
Our kit family is in the (EU) 2017/746 IVDR conformity assessment process. A written agreement has been signed with SGS Belgium NV (Notified Body NB 1639) per IVDR Annex VII Section 4.3, and the formal application has been completed.
Our manufacturing system conforms to ISO 13485. Existing kits carry CE-IVD marking under IVDD and are registered with TİTCK (Turkish Medicines and Medical Devices Agency).
Under (EU) 2024/1860 transition provisions: Class B kits — 31 December 2029; Class C kits — 31 December 2028. Kit supply and clinical use continue uninterrupted.
Most PCR companies make the kit chemistry themselves but buy the software from outside. We develop both under one roof. When a new kit family is designed, the multiplex probe chemistry, the UMS analysis parameters and the clinician report are designed together — the product's three layers emerge from a single R&D cycle.
This approach lets pilot-lab feedback flow directly back into the kit chemistry. Threshold values, curve quality, false-result patterns — all are measured through UMS and feed into the next kit revision.
ANT Biotech processes personal data in accordance with Türkiye's Personal Data Protection Law (KVKK No. 6698) and the EU General Data Protection Regulation (GDPR). For requests regarding access, correction or deletion of personal data, please contact us at the address below.