Molecular Biology Services
KCAS Bio delivers GLP and non-GLP molecular biology services for PK/biodistribution, PD/biomarkers, and safety assessments supporting gene therapies, cell therapies, RNA therapeutics, and other advanced modalities. Using qPCR and ddPCR, we develop and validate DNA and RNA methods to support confident decisions from discovery through clinical development.
Your right bioanalytical partner for molecular biology testing
Deep Molecular Expertise
Our team brings 100+ years of combined qPCR and ddPCR experience, offering high-quality assay development and design, method transfer, and full validation tailored to your therapeutic program
Advanced Platforms
Six-color qPCR and two-color ddPCR systems support sensitive detection for biodistribution, shedding, biomarkers, gene expression, copy number, and rare sequence analysis.
Purpose-Built Molecular Facility
A unidirectional workflow with dedicated rooms for sample processing, DNA/RNA extraction, reagent preparation, template addition, and PCR amplification to ensure contamination control, precision, and reproducible data.
Mastery of Challenging Samples
We isolate nucleic acids across a wide variety of tissues and species, maintaining assay sensitivity, even in difficult matrices.
Regulatory-Ready Approach
All molecular workflows can be executed under GLP, GCP, or non-GLP, with documentation aligned to FDA, EMA, ICH S12 and MIQE/ dMIQE expectations.
What are molecular biology services?
Molecular services use PCR (qPCR and dPCR) and genomic technologies to quantify DNA and RNA, providing critical insights into how advanced therapies behave in the body. These assays track distribution, shedding, transgene expression, biomarker changes, and genetic variation, supporting dose selection, optimizing therapeutic strategies, and generating regulatory-compliant data to accelerate development programs.
Our molecular capabilities support drug development with:
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PK / Biodistribution: Track AAV, LNP, small RNAs, and lentiviral cargo, ALU repeats, and small RNA persistence (siRNA, gRNA)
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PD / Biomarkers: Assess mRNA expression, mutations, transgenes, and splice variants
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Safety: Monitor viral shedding and replication-competent lentivirus
Your molecule, our expertise. Let KCAS Bio help with your molecular biology related project.
Applications of molecular biology services in drug development
Therapeutic Areas
Oncology: Quantification of tumor-associated biomarkers, detection of circulating tumor DNA (ctDNA), and measurement of gene expression changes supporting targeted therapies, immuno-oncology agents, and cell-based treatments.
Gene & Cell Therapy: Biodistribution and shedding analysis, vector genome quantification, transgene expression, and tracking of gene-modified cells to evaluate safety, exposure, and therapeutic persistence.
Infectious Diseases & Vaccines: Measurement of pathogen DNA/RNA, viral load, and molecular signatures supporting vaccine development and infectious disease therapeutics.
Rare & Genetic Diseases: Identification of genetic variations, copy number changes, biomarker expression to assess therapeutic response and disease progression.
Phases of Drug Development
Discovery: Early molecular characterization to identify biomarkers, assess target engagement, and guide therapeutic strategy using rapid qPCR/ddPCR feasibility assessments.
Preclinical Studies: GLP-enabled biodistribution, shedding, and PD biomarker assays supporting toxicity studies, dose selection, and species bridging.
Clinical Development: Implementation of validated molecular assays for biodistribution, shedding, and biomarker monitoring, generating regulatory-compliant data from IND through late-stage trials.
Capabilities and assays using molecular biology services and solutions
Our molecular laboratory applies qPCR and ddPCR assays across sample types and diverse modalities, providing actionable insights on biodistribution, gene expression, biomarkers, and genetic variation to support drug development and regulatory submissions.
PK / Biodistribution
Track the distribution and persistence of AAV, LNP, and lentiviral cargo in target and non-target tissues and biofluids. Capabilities include copy number analysis for transgenes, ALU repeat assays to quantify human genomic DNA in preclinical species, cell persistence measurements, and small RNA pharmacokinetics for siRNA and gRNA, including microRNA profiling and stem-loop RT-qPCR for pharmacokinetics.
PD / Biomarkers
Quantify mRNA gene expression, transgene expression, circulating tumor DNA (ctDNA), single-nucleotide polymorphisms (SNPs) and splice variants to assess pharmacodynamic effects, ADME-related biomarkers, and mechanism of action.
Safety
Conduct shedding studies to measure viral vector presence in excreta and secreta and assess environmental exposure and transmission risk. Assays also include sensitive detection of replication-competent lentivirus to support regulatory safety requirements.
Custom Assay Design
Develop and optimize qPCR and ddPCR assays tailored to unique study requirements.
Technology and instrumentation for molecular biology services
Our molecular biology laboratories are equipped with state-of-the-art instrumentation to deliver maximum sensitivity, enabling precise quantification of DNA, RNA, transgenes, and biomarkers across a variety of biological matrices.
We have advanced technology to move your science forward. Speak with a KCAS Bio expert now.
Why work with KCAS Bio?
Full-Service Bioanalysis
End-to-end method development, validation, and reporting under one roof.
Regulatory Expertise
Deep familiarity with ICH, FDA, and EMA requirements.
Cutting-Edge Technology
Best-in-class qPCR and ddPCR equipment.
Flexible, Customized Workflows
Tailored workflows to meet unique project goals and timelines.
Broad Sample Type and Matrix Expertise
Plasma, serum, urine, CSF, and tissues plus unstable/rare matrices and microsampling methods
Global Presence with Harmonized Quality
Consistent technical standards and harmonized operations worldwide
Molecular Biology Services FAQs
What is the difference between qPCR and ddPCR?
qPCR (quantitative PCR) measures DNA or RNA in real-time, providing relative or absolute quantification. ddPCR (droplet digital PCR) partitions the sample into thousands of droplets for highly precise, absolute quantification, ideal for rare sequence detection, low-copy targets, or when only limited amounts of input material are available.
What sample types do you analyze?
Our team has extensive expertise in sample processing and nucleic acid isolation from a wide range of tissues, biofluids, and species, ensuring high-quality input material for reliable downstream molecular assays.
Do you support non-GLP and GLP studies?
Yes. KCAS Bio supports both non-GLP and GLP studies, with workflows designed to meet regulatory compliance and data integrity requirements.
Additional resources
Blogs
The bioanalysis world has exploded with the need for molecular assays (qPCR, dPCR, NGS, Hybridization technologies) due to the demand for both biodistribution/PK and PD/BM analysis of various drug modalities. Many of these molecular assays have been around for decades and are now routine methods. CLIA and reference labs have…
Blogs
Polymerase Chain Reaction (PCR) has revolutionized molecular biology by enabling the rapid and precise amplification of DNA sequences. Since its invention by Kary Mullis in the 1980s, PCR has become an indispensable tool in both research and diagnostic applications. From identifying genetic disorders to detecting infectious diseases, PCR’s versatility has…
Blogs
Polymerase chain reaction (PCR) assays (including digital PCR and quantitative PCR) can be used to detect and measure nucleic acids such as DNA, RNA, small RNAs, and non-coding RNAs. What may be surprising is how few guidelines and whitepapers are available for bioanalytical support for regulated Bioanalysis by dPCR and…
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