- Home
- IVD
- By Technology Types
- By Diseases Types
- By Product Types
- Research
- Resource
- Distributors
- Company
| Product Name | GMP-Grade Primer Synthesis for In Vitro Diagnostic Manufacturing |
| Catalog No. | PRIPRO-0028 |
| Description | A primer synthesis service producing oligonucleotides under GMP-compliant quality systems for use as raw materials in commercial in vitro diagnostic kit manufacturing. The service includes full documentation traceability, raw material qualification, in-process controls, and final product release testing. Synthesized primers meet the quality requirements for CE-marked and regulatory-submitted IVD products. |
| Intended Use | Supply of oligonucleotide primers as qualified raw materials for commercial diagnostic kit manufacturing. |
| Principle / Technology | Solid-phase phosphoramidite oligonucleotide synthesis under GMP quality management system |
| Detection Method | HPLC purity analysis; MALDI-TOF or ESI mass spectrometry identity confirmation; endotoxin and bioburden testing |
| Sample Type | Purified nucleic acid targets from clinical specimens for infectious disease, oncology, and genetic testing IVD kits |
| Performance Range / Specifications | Synthesis scale: 1 µmol to 1 mmol; full-length product purity: ≥95% by HPLC; endotoxin: ≤0.05 EU/mg |
| Sensitivity / LOD | Lot-to-lot performance consistency verified by qPCR Ct value comparison with reference primer lot |
| Specificity | Each production lot identity confirmed by mass spectrometry |
| Reaction Conditions / Protocol | GMP synthesis follows validated production procedures; each lot accompanied by certificate of analysis and certificate of conformance; change control process for any raw material or process modifications |
| Components / Formulation | Lyophilized oligonucleotides in individual vials; certificate of analysis, certificate of conformance, and material safety data sheet provided |
| Storage Conditions | Lyophilized: –20 °C; batch-specific retainer samples archived for stability monitoring |
| Shelf Life | 36 months lyophilized at –20 °C per stability protocol |
| Package Specifications | Per primer: customized per customer specification; typical: 1–100 µmol scale |
| Product Form | Lyophilized solid |
| Quality Control | Full GMP documentation package: CoA (purity, mass, water content, endotoxin, bioburden), CoC, batch production record extract available under quality agreement |
| Key Features | GMP-grade primers eliminate the regulatory risk of using research-grade starting materials in commercial diagnostic products |
| Purity | HPLC purification ≥90% full-length product; desalted ≥85% |
| Concentration | As specified in synthesis report; typically lyophilized or at 100 µM in TE |
| Activity / Unit Definition | Primer efficiency 90–110% in qPCR; Tm within ±2 °C of calculated value |
| Molecular Weight | As specified per MALDI-TOF certificate; within 0.1% of theoretical mass |
| Source / Origin | Solid-phase phosphoramidite chemical synthesis |
| pH Range / Optimal pH | Stable in TE buffer pH 7.0–8.0; avoid acidic conditions causing depurination |
| Shipping Conditions | Ambient temperature for lyophilized oligos; cold packs for fluorescent probes |
| Expiration Date / Stability | 24 months lyophilized at –20 °C; 6 months reconstituted at –20 °C |
| Regulatory / Compliance | Research use as standard; GMP-grade with full documentation available |
| Compatibility | Compatible with standard PCR, qPCR, and sequencing platforms |
| Recommended Buffer System | Resuspend in nuclease-free water or TE buffer pH 8.0 |
| Application Notes / Precautions | Protect fluorescent probes from light; avoid repeated freeze-thaw cycles; aliquot for single use |
| Batch-to-Batch Consistency | MALDI-TOF mass confirmation per lot; qPCR performance within 0.5 Ct of reference lot |
For research use only, not for clinical use.
|
There is no product in your cart. |
Copyright © 2026 Alta DiagnoTech. All rights reserved.
