GMP IVD Manufacturing in Nanjing

Vertical Integration

Progene Bio is a vertically integrated IVD manufacturer — in-house raw materials, membrane chromatography, cassette assembly and packaging under a GMP quality system.

• 600+ SKUs across 12 series
• Colloidal-gold lateral flow platform + fluorescence immunoassay (FIA)
• In-house core raw materials — diagnostic antibodies and antigens developed internally
• ISO 13485 medical quality management system
• Batch consistency — controlled membrane coating for reproducible results

OEM / ODM Capabilities

• Private label & custom branding
• Custom analyte panels (e.g., drug-of-abuse cups up to 14 panel)
• Custom packaging, IFU and documentation
• Registration support documents (validation, CE files)
• OEM validation — customized formulations are re-validated for cut-off, sensitivity and specificity before release

Manufacturing Process

Colloidal-gold lateral-flow production — every step is controlled for batch-to-batch consistency, because each step affects the final sensitivity and clarity of the result line.

1. Raw materials — antibodies, antigens and nitrocellulose membranes are qualified and lot-tested before production. Inconsistent raw materials are the most common source of batch variation.
2. Membrane preparation — test and control lines are dispensed onto nitrocellulose at controlled width and density; line sharpness determines readability.
3. Conjugate preparation — colloidal gold is conjugated to detection antibodies; particle size (~40 nm) and antibody density control signal intensity.
4. Reagent dispensing & drying — conjugate and sample pads are prepared and dried under controlled humidity; residual moisture affects stability.
5. Strip assembly — pads are laminated onto backing card with controlled overlap; misalignment causes flow failure.
6. Cassette assembly — strips are cut and loaded into cassettes or panel cups; each device is visually inspected.
7. Packaging — sealed foil pouch with desiccant to protect against humidity; kit labeling with lot and expiry.
8. QC & batch release — each lot is tested against reference panels for sensitivity, specificity and precision; only lots meeting specification are released.

Quality, Stability & Traceability

• Batch validation — each lot is validated against reference methods; sensitivity and specificity are documented per product line.
• Stability — room-temperature-stable (no cold chain), controlled-humidity packaging with desiccant; expiry set from real-time and accelerated stability data.
• Traceability — lot-level traceability from raw material to finished device, supporting recalls and audits.
• Quality system — ISO 13485 (GB/T 42061) medical quality management; CE-marked lines support regulated-market registration.