Molecular Services

KCAS Bio provides comprehensive bioanalytical laboratory services to support the development of cell and gene therapies from its purpose-built facilities in the US and Europe. Techniques and services include ddPCR, qPCR, Cell-Based Assays, Receptor Occupancy, Cell-Sorting, Biodistribution, Viral Shedding, Immunogenicity and Biomarkers.

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Molecular services, purpose-built expertise

The KCAS Bio team has over 100+ years of combined experience in molecular services to support pre-clinical and clinical trials in various species, developing and validating methods and analyzing samples from a wide range of matrices. Whether a method is transferred or requires method development and validation, KCAS Bio will listen and support the best path forward.

KCAS Bio adheres to FDA-GLP good laboratory practices for cell and gene therapies. Our new state-of-the-art facility has a unidirectional workflow with two dedicated preamplification areas and a dedicated post-amplification area.

Full array of molecular capabilities

KCAS Bio offers a complete array of genomics-based assays using modern platforms. From discovery, preclinical studies through clinical trials, KCAS Bio is a highly experienced provider in supporting advanced modalities. Our team has expertise in biodistribution studies, molecular genomics, pharmacokinetic/pharmacodynamic (PK/PD), and biomarkers. Our dedicated team works in a built-for-purpose laboratory and works closely with customers on their programs. Our scientists have worked with many types of drug candidates.

KCAS Bio offers real-time quantitative (qPCR) and reverse transcriptase PCR (ddPCR)

qPCR & ddPCR

Molecular services

  • SiRNA/mRNA
  • Adeno-associated virus (AAV)
  • CAR-T therapy
  • Polymers
  • Enzyme replacement therapy
  • Lipid nanoparticles
  • CRISPR/Cas9
  • Oligonucleotides
  • Targeted delivery mechanisms

qPCR & ddPCR experience

  • Assessments of nucleic acid therapeutics, including biodistribution/shedding studies and quantitation of the transgene mRNA for gene and cell therapies
  • VCN (vector copy number)
  • Gene expression analysis
  • Cytokine mRNA profiling in immune response
  • Biomarker assessment
  • CYP mRNA induction

More to the puzzle

KCAS Bio is rapidly embracing the advancement of using AI to support our teams in producing the highest quality data – to assure the highest levels of quality and integrity.

In addition to the services listed above, KCAS Bio also offers additional gene product expression product analysis via LC-MS, Hybrid LC-MS, flow cytometry, ELISA, MSD, Luminex and additional ligand binding platforms to support all phases of drug development.

Moreover, we have experience in cell-based neutralizing antibody assays, anti-drug antibody (ADA), protein product delivery vector, and bioanalysis by ion-pair liquid chromatography coupled with mass spectrometry (via LC-MS/MS) and IP-LC-UV.

Interested in Flow Cytometry? KCAS Bio provides custom assay development, validation, sample processing and consulting services for a wide variety of applications. We measure a variety of targets on a wide range of cells, including T cells, B cells, macrophages/monocytes, basophils, neutrophils, dendritic cells and cell-derived particles.

Flow Cytometry Services

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We've earned our reputation for delivering reliable, error-free data. We understand the importance of speed, flexibility, and consistency and only make promises we can keep.

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Related services

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We prepare and adapt our services based on a deep understanding of your drug development ambitions and wider business objectives.

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