PCR Expertise for Gene Therapy

Enhance your gene therapy program with expert PCR (polymerase chain reaction) bioanalysis. From discovery to clinical trials, our comprehensive qPCR (quantitative PCR) and ddPCR (droplet digital PCR) services provide the precision needed to identify and quantify therapy-target DNA or RNA sequences in complex biological matrices.

Leveraging expert assay design and tailored method validation, we amplify minute genetic material into actionable data. Partner with us for high-sensitivity biodistribution, shedding, and transgene expression studies that meet rigorous regulatory standards.

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Our PCR Capabilities

From early development through clinical advancement, we partner closely with clients to deliver reliable, regulatory-ready molecular bioanalysis solutions.

Our expert scientific teams specialize in the qualification and validation of proprietary DNA and RNA assays, providing high-quality data for seamless integration into your IND, CTA, or BLA regulatory submissions.

Depending on the specifics of your program, we can integrate complementary bioanalytical approaches, including flow cytometry, ligand binding assays, mass spectrometry, and immunogenicity assays, providing additional pharmacokinetic and pharmacodynamic assessments of your therapeutic.

High-Precision PCR Platforms for Gene Therapy Bioanalysis

Our laboratory utilizes state-of-the-art PCR space and equipment to deliver sensitive, reproducible data required for FDA-compliant gene therapy packages. Whether supporting biodistribution studies, vector shedding analyses, or transgene expression monitoring, we tailor our molecular strategies to your program’s specific bioanalytical relevance.

Quantitative PCR: Validated Precision for Regulatory Filings

Quantitative PCR (qPCR) remains a high-throughput, sensitive detection of nucleic acids. We employ qPCR to perform absolute quantification of gene therapy targets, ensuring your data meets the rigorous standards of IND, CTA, and BLA submissions.

Standard Curve Excellence: Accuracy in qPCR hinges on a reliable reference standard. We develop robust standard curves using carefully designed controls to determine target copy numbers with extreme precision.
Multiplexing Capabilities: For alternative programs, we design multiplexed assays that quantify two or three gene targets in a single reaction for decreased hands-on processes and efficient data generation.
Reagent Quality: Success is determined by the quality of primers, probes, and positive controls. Our expert team ensures that every reagent is optimized to eliminate off-target amplification and prioritize sensitivity.

Scientific Journal

Droplet Digital PCR

For applications requiring superior sensitivity or detection in inhibitor-rich samples, we offer droplet digital PCR (ddPCR). This technology provides absolute quantification of your target sequence without the need for a standard curve.

The Power of Partitioning: By partitioning each reaction into thousands of nanoliter-sized droplets, ddPCR enables a binary counting method (positive vs. negative). Poisson distribution analysis is used to calculate the exact starting concentration of your target DNA or RNA.
Resistance to Inhibitors: ddPCR is uniquely suited for complex biological matrices, such as blood, tissue, or fecal matter used in shedding studies, where traditional qPCR may include unknown inhibitors.
Enhanced Reproducibility: Because it does not rely on a standard curve, ddPCR minimizes plate-to-plate variability, making it an ideal choice for vector copy number (VCN) assessments.

Comparison of qPCR and ddPCR Characteristics

*Please note that ddPCR is specifically a Bio-Rad platform.*
qPCR	ddPCR
Standard curve required for quantification; quantification based on a reliable standard and/or positive control.	No standard curve required for quantification; positive controls required as assay controls.
Can detect between 5.00 x 10¹ and 5.00 x 10⁷ copies of target.	Maximum copy number detection is between 1.5 x 10⁵ and 1.7 x 10⁵.
Cost-effective reagents, generally speaking, for standard to high-throughput analyses.	Consumables for Automated Droplet Generator and vendor kit supplies are quickly cumulative. More cost-effective for high-throughput studies.
A reliable and trusted method of quantitation; relative expression can be adapted.	Precise, binary results. Low error rate, overcomes PCR inhibitors.

Our PCR team in Seattle works with state-of-the-art equipment to support assay creation.
Our set-up includes:

Dedicated PCR hoods and laboratory spaces
8 QuantStudio™ 7 Pro real-time PCR systems
- 96- and 384-well capabilities
2 Automated Droplet Generators (for ddPCR)
2 QX200 Droplet Readers (for ddPCR)
3 KingFisher Flex purification systems
NanoDrop™ spectrophotometers
Specialized DNA and RNA isolation techniques for common and unique biological matrices for biodistribution, vector shedding, and more.

Integrated Bioanalytical Support

Beyond molecular quantification, we offer a comprehensive suite of services to provide a holistic view of your therapeutic's performance, including ligand binding assays, flow cytometry, and LC-MS/MS for pharmacodynamic profiling.

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Why Choose Altasciences
for PCR Bioanalysis?

Choosing the right partner for your molecular bioanalysis is a critical step in streamlining your drug development journey. With over 30 years of experience in molecular assay development, Altasciences provides the scientific depth and technological infrastructure to move your gene therapy from bench to clinic with confidence.

Expert Biodistribution and Shedding Assessments

We design PCR quantification assays for the mandatory biodistribution assessments for regulatory submission packages for cell and gene therapies. These studies provide essential data regarding the therapeutic’s movement, persistence, and target localization in vivo, tracking your therapeutic across varying dosages and time points. Our expertise extends to viral vector shedding analyses, ensuring you have the data necessary to evaluate patient and environmental safety—a key requirement for both FDA and EMA submissions.

Versatility Across Vectors and Matrices

Gene therapy delivery mechanisms are improving and developing. Our scientists have extensive experience validating assays for a wide range of delivery vehicles, including:

Viral Vectors: Specialized protocols for AAV, lentivirus, and adenovirus.
Non-Viral Delivery: Precision quantification for lipid nanoparticles (LNPs) and capsids.
Diverse Biological Matrices: Validation of PCR qPCR and ddPCR assays in challenging matrices, including whole blood, various tissues, bone marrow, and excreta.

Case Study

Scientific Excellence in Assay Development

A "one-size-fits-all" approach does not work for advanced therapeutics. Our subject matter experts focus on optimal primer and probe design, ensuring binding specificity and minimal background noise. We specialize in:

Assay Optimization and Troubleshooting: Overcoming PCR inhibition in complex samples.
Method Validation: Establishing GLP-compliant assays that stand up to regulatory scrutiny.
Dual Platform Flexibility: Whether your program requires the high throughput of qPCR or the absolute quantification of ddPCR, we provide the technology that best fits your quantification requirements.

Your Partner in the Therapeutic Pipeline

From discovery and nonclinical studies through clinical trials, Altasciences integrates PCR analysis into a broader bioanalytical strategy. By combining molecular data with immunogenicity, flow cytometry, and pharmacokinetic (PK) assessments, we deliver a holistic package for your therapeutic.

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Click below to explore more of Altasciences' bioanalytical solutions.

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FAQ: ANSWERING YOUR KEY QUESTIONS ABOUT PCR

Here are some answers to our most-asked questions:

What is PCR analysis used for?

Commonly, PCR is utilized to assess biodistribution of gene therapies in preclinical animal testing.

How does PCR work?

PCR involves genetic material undergoing rapid replication [amplification] during repeated cycles of heating and cooling. A PCR sample reaction contains reaction buffer, nucleotides, enzymes, primers and probes, and DNA or RNA template. Primers and probes are designed to be target specific; all reaction mix components are optimized for each individual assay. With each thermal cycle (rapid heating and cooling), fluorescent probes allow for quantification of the amplified target, which increases exponentially every thermal cycle in an optimally efficient reaction. The fluorescent quantification over time allows for target copy number to be determined in each individual reaction.

What is the quantification difference between qPCR and ddPCR?

ddPCR has a smaller quantification range than qPCR and is considered more accurate for low-level copy number assessments or when PCR inhibitors may factor in. qPCR is suitable for assessments requiring a larger quantification range for unknown distributions or quantities and is reliable in dose-range finding studies when initially learning about therapeutic kinetics in vivo.