PCR Platform
Polymerase Chain Reaction (PCR), together with its advanced upgraded variants—real-time quantitative PCR (qPCR) and digital PCR (dPCR), is a core foundational technology for high-sensitivity, high-specificity nucleic acid detection and quantitative analysis in the biopharmaceutical industry. Conventional PCR realizes targeted amplification of specific DNA/RNA fragments via three standard thermal cycling steps: denaturation, annealing, and extension, enabling efficient enrichment and qualitative identification of target nucleic acid sequences. qPCR introduces real-time fluorescence signal monitoring to synchronously record amplification data during the reaction, supporting relative quantitative analysis based on standard curves; dPCR adopts sample micro-partition technology, achieves absolute quantification through Poisson statistical analysis after endpoint amplification, and excels in trace target detection. The core advantages of PCR, qPCR and dPCR are compared in detail below:
| Technology Type | Core Advantages | Applicable Scenarios |
| Conventional PCR | Simple operation, low cost, fast amplification speed, strong specificity for target nucleic acid fragments, suitable for preliminary qualitative detection |
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| qPCR (Real-time Quantitative PCR) | Real-time dynamic monitoring, wide quantitative range, high throughput, good reproducibility, cost-effective for routine quantitative testing, mature supporting methodology |
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| dPCR (Digital PCR) | Ultra-high sensitivity, absolute quantitative detection without standard curves, strong anti-interference against complex biological matrices, ultra-low target detection capability, high accuracy |
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PCR Platform
PharmaAnalytica has built a fully automated, high-precision integrated PCR technology platform dedicated to biopharmaceutical bioanalysis, equipped with mainstream high-performance domestic analytical instruments to guarantee standardized, efficient and stable experimental operations.
NP968-S Fully Automated Nucleic Acid Extractor
NP968-S adopts an automated nucleic acid extraction method based on magnetic bead adsorption and separation, which perfectly overcomes the shortcomings of traditional nucleic acid extraction approaches and realizes rapid and efficient sample preparation. It is equipped with 15/32/48 three flexible flux modules, and can handle a wide range of sample types paired with matched special nucleic acid extraction reagents, including serum, plasma, whole blood, swabs, amniotic fluid, feces, tissue lavage fluid, tissue, paraffin sections, bacteria, fungi and other complex biological samples.
PANA9600X Fully Automated Nucleic Acid Workstation
PANA9600X is an all-in-one automated workstation that integrates multiple core functions including sample scanning, sample loading, nucleic acid extraction and PCR reaction system construction, realizing full-process automated and closed-tube operation and perfectly guaranteeing the accuracy, repeatability and efficiency of downstream qPCR and dPCR quantitative detection. It can efficiently extract target nucleic acids from diverse clinical and biological samples within a shorter testing cycle, such as whole blood, serum/plasma, swab washing solution, urine and other matrices commonly used in drug bioanalysis.
SLAN-96S Real-Time Fluorescent Quantitative PCR System
SLAN-96S supports multi-channel fluorescent signal synchronous detection, with wide quantitative range and excellent stability. It is mainly used for relative quantitative analysis of nucleic acid drugs and gene therapy products, including gene expression level detection, medium-high abundance target nucleic acid quantification, routine drug residue screening, and bacterial vector safety testing; it adapts to batch sample analysis, providing efficient and reliable data support for preclinical pharmacodynamic evaluation and preliminary quality control.
Sniper DQ24 Digital PCR Analyzer
Sniper DQ24 realizes absolute quantitative detection of trace nucleic acids without standard curves, with ultra-high sensitivity and strong matrix anti-interference. It is the core equipment for high-end bioanalysis of cell and gene therapy drugs, specially used for AAV vector titer detection, trace host cell DNA residual quantification, low-abundance therapeutic biomarker monitoring, and in vivo trace nucleic acid drug distribution analysis; it perfectly meets the strict quantitative requirements of innovative drug R&D and regulatory compliance.
Covered Drug Categories for Bioanalysis
Supported by our mature and stable integrated PCR technology platform, PharmaAnalytica provides customized, full-process bioanalysis services covering a full spectrum of nucleic acid drugs and cell and gene therapy products. We deliver targeted testing solutions for each drug type, matching corresponding PCR technologies to meet strict R&D and regulatory demands. The covered drug categories are listed as follows:
- Plasmid DNA
- Hairpin small RNA
- Circular mRNA
- LNP-encapsulated mRNA (LNP mRNA)
- Exosome siRNA
- CRISPR/Cas9 gene editing products
- Adeno-Associated Virus (AAV) vector
- Bacterial vector
From conventional nucleic acid preparations to advanced targeted delivery systems, our platform supports full-lifecycle testing from preclinical research to clinical trial support, ensuring stable and reliable data output.
Core PCR-Based Bioanalysis Services
PharmaAnalytica leverages high-performance PCR, qPCR and dPCR technologies to provide compliant, standardized full-chain bioanalysis services, covering core research links of drug R&D, quality control and clinical application. Each service type is elaborated below:
Pharmacokinetics (PK) & Biodistribution Analysis
We conduct precise quantification of nucleic acid and gene therapy drugs in various biological matrices, clarifying in vivo drug absorption, distribution, metabolism and excretion (ADME) profiles, as well as tissue targeting distribution, to support drug efficacy and safety evaluation.
Pharmacodynamic (PD) & Mechanism Research
This service focuses on analyzing drug-target interaction effects, detecting changes in target gene expression levels, and revealing drug therapeutic mechanisms, providing solid data support for drug mechanism validation and dosage optimization.
Drug Metabolism Analysis
We explore drug metabolic pathways and detect metabolic gene polymorphism differences, evaluating individual differences in drug metabolism, providing a scientific basis for individualized medication and clinical dosage adjustment.
Drug Quality Control & Residue Detection
We carry out strict compliance testing including host cell DNA residue detection, viral/bacterial vector titer quantification, and pathogenic microorganism contamination screening, fully meeting pharmaceutical regulatory requirements and drug quality control standards.
Clinical Efficacy Monitoring
With high-sensitivity nucleic acid detection technology, we track disease-related therapeutic biomarkers, objectively assess clinical treatment response, and support real-time dynamic monitoring of disease treatment and recurrence risk.
At PharmaAnalytica, we are committed to empowering the innovation of nucleic acid and cell & gene therapy industries with reliable technical services and professional data support. Our high-precision PCR platform, integrated with automated workflows and compliant operating systems, is ready to partner with biotech enterprises, pharmaceutical research institutions, and global customers to accelerate the R&D pace of innovative drugs and solve critical challenges in the bioanalysis field. Whether it is preclinical research verification or clinical trial sample support, we will always adhere to the concept of "precision, compliance, and efficiency" to provide you with one-stop bioanalysis solutions, jointly promoting the transformation of scientific and technological achievements and making positive contributions to the development of global biopharmaceutical cause.
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