Request feasibility ↗PCR and RT-qPCR reagent and kit production from oligonucleotide control through validated finished kits.
Request feasibility study ↗PCR and RT-qPCR reagent and kit production from oligonucleotide control through validated finished kits. The investment case is tested against import dependency, procurement demand, supply resilience, attainable local content and regional export access. Portfolio definition precedes equipment selection so capital is not locked into an incompatible process.
USD 2.4–6.8M. The range covers core equipment, controlled environments, process utilities, installation, qualification, technology transfer and initial training at the stated tier. Preliminary engineering range; excludes land, finance cost, taxes and import duty. Final scope and price are confirmed at the feasibility gate.
1,200–2,800 m² gross; 350–900 m² controlled production, typically ISO 8 with ISO 7 formulation/filling zones where risk assessment requires.
ISO 8 background is typical for reagent preparation support; ISO 7 local zones may be specified for exposed formulation/filling. Pre- and post-amplification QC rooms are physically separated to control amplicon contamination.
12–18 months from approved design basis to validated pilot batch. Permit, authority review, civil-condition, customs and client approval delays sit outside the base programme unless expressly contracted.
Tier 1: 1–3M tests/year; Tier 2: 5–12M tests/year; two shifts, product mix and lyophilisation cycle dependent.
Capacity assumes qualified materials, stated shifts, planned maintenance and validated yield; it is not the sum of nominal machine speeds.
Redundant power, 18–25°C temperature control, humidity control where lyophilised formats are handled, monitored 2–8°C and frozen storage, purified water where formulation requires, segregated QC airflow and data backup.
ISO 13485 QMS readiness; IVDR technical-documentation and local registration pathway. Typical facility/QMS readiness: 9–15 months; product registration is authority-dependent.
Infinity IVD delivers the contracted facility, QMS, validation and dossier work. Certification or market authorisation is granted only by the competent independent authority.
Indicative 22–55 FTE across production, molecular QC, QA, regulatory, warehouse, maintenance and supervision; 6–12 weeks role-based training plus supervised pilot batches.
The feasibility equipment register identifies supplied equipment, client-supplied items, spares, initial consumables, FAT/SAT responsibility, calibration and qualification ownership.
Operating economics are issued as a sensitivity model using local labour, utilities, materials, yield, utilisation and financing assumptions; they are not a guaranteed return.
Client names and photography are disclosed only with permission; confidential programmes retain a technical envelope rather than an invented attribution.
Review programme evidence ↗The investor brief records the published assumptions, process flow, capacity tiers, regulatory route and data required for a binding feasibility package.