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Molecular

Molecular bioanalysis

Count on Labcorp's Molecular Bioanalytical Services breadth and depth of scientific expertise to help you along your drug development journey. From cell to gene therapies and biotech to pharma clients, our highly experienced subject matter experts will partner with you to deftly advance your drug development goals along the development continuum.

With over 20 years of molecular bioanalytical experience and industry thought leadership insights, we can help you advance even your most challenging projects when it matters most. Located across three global sites in the U.S., U.K.and Asia, we are ready to partner with you to help you achieve your next milestone.

Available molecular bioanalytical assays

Labcorp's Molecular Bioanalytical Services has deep experience in the three main and ancillary types of assays used in the development of cell and gene therapies throughout the drug development life cycle, including biodistribution, vector shedding and vector copy number.

 BiodistributionVector SheddingVector Copy Number (VCN)
DefinitionAssessment of the distribution of ATMP/GTMP material within a specific in vivo modelRelease of virus-based gene therapy product from the animal or patient

VCN is sometimes referred to as cellular kinetics and involves monitoring the persistence and expansion of adoptive cell therapies

Sometimes used by sponsors to talk about biodistribution + vector shedding studies as same assay can be used to measure both

Nucleic acid measured

DNA – presence of viral vector within an organ/body fluid/excreta

RNA – confirm if infection, and subsequent transcription, have occurred or look at up/downregulation of gene expression after dosing

DNA/RNA dependent on viral vector used – look at biofluids, over time, for clearance of viral vector

DNA – AVV

DNA – any DNA modified viral vector (e.g., Ad-5)

RNA – Lentivirus

RNA – Lentivirus and retrovirus

DNA/RNA dependent on viral vector used – How much of the transgene or plasmid can we detect in sample cells?

DNA – AAV

RNA – lentivirus

Time pointsAnimal model dependent but typically 1 week, 1 and 3 monthsUsually baseline, then multiple up to a point where levels are no longer detected where 2-3 consecutive negatives are reportedDuring dosing and long-term follow-up post-dosing
Material testedVarious tissues, depending on target organ; may incorporate vector shedding alongside so it could include urine, blood, fecesAnimal or patient excreta such as urine, feces, semen, tears, saliva, blood and/or components, CSFUsually the pre-dose or post-dose material, so usually small sample numbers
AssayqPCR or RT-qPCR as sample numbers are usually large and these assays have a larger dynamic range to cover values from all sample types; see values in range of 10e0 to 10e10+ (dd-PCR or ddRT-qPCR could also be used, but it is very expensive and has less throughput and smaller dynamic range for this study type) qPCR or RT-qPCR as sample numbers are usually large and these assays have a larger dynamic range to cover values from all sample types; see values in range of 10e0 to 10e10 (dd-PCR or ddRT-qPCR could also be used, but it is very expensive for this study)

ddPCR is a better fit due to the potential for small quantities of the target molecular in complex matrices (and also better precision needed); it’s not linked to the number of samples (although it takes longer and will be more expensive)

Recommended for clinical assessments not preclinical studies

PlatformQIAsymphony®/KingFisherTM for extraction QuantStudioTM Flex 6 and 7 for PCRQIAsymphony/KingFisher for extraction QuantStudio Flex 6 and 7 for PCRQIAsymphony/KingFisher for extraction and Bio-Rad® QX200 for PCR
SiteHGT + GRNHGT + GRNHGT + GRN

Table 1: Labcorp Molecular Bioanalytical Services assay list 

Available molecular bioanalysis platforms  

Labcorp's Molecular Bioanalytical Services also has deep expertise in the four main molecular assay platforms used for the development of cell and gene therapies throughout the drug development life cycle, including qPCR, RT-qPCR, ddPCR and ddRT-PCR.

                   qPCR                  RT-qPCR                          ddPCR                                   ddRT-PCR                                        
OligonucleotideDNARNADNARNA
InstrumentationQuantStudio Flex 6 and 7QuantStudio Flex 6 and 7Bio-Rad QX200Bio-Rad QX200
Well format96- or 384-well format96- or 384-well format96-well format96-well format
QuantitationAbsoluteAbsolute
Relative
AbsoluteAbsolute
Relative
DyesFAM. VIC, JOE, TAMRA, ROX, MGB SYBR GreenFAM. VIC, JOE, TAMRA, ROX, MGB SYBR GreenNANA
StagePreclinical
Clinical
Preclinical
Clinical
Preclinical
Clinical
Preclinical
Clinical
ApplicationsBiodistribution
Viral shedding of DNA target
vcn
Biodistribution
Viral shedding of RNA target
VCN
Up- and downregulation of target gene
Biodistribution
Viral shedding of DNA Target
VCN
Biodistribution
Viral shedding of RNA target
VCN
Up- and downregulation of target gene

Table 2: Labcorp Molecular Bioanalytical Services platform list

Available product lines

From preclinical to clinical development needs, Labcorp's Molecular Bioanalytical Services has a range of assay design and testing solutions to help you along the drug development continuum. 

                                    PreclinicalClinical                                       
Types of studies run

Biodistribution

  • Determine distribution of cell or gene therapy (C&GT) product around animal model 
  • Helps determine sites of accumulation in human
  • Assess potential sites of toxicity through distribution, accumulation and persistence of the product

Vector shedding

  • Determine shedding of C&GT product in animal model 
  • Helps determine likely action in human (provided suitable animal model used that has similar mode of action as in human

Vector shedding

  • Determine shedding of C&GT product in humans 

VCN

  • Determine VCN in material
Automated/manual extractions
(HGT + GRN)
DNA extractions – automated extraction
RNA extractions – automated extractions
DNA extractions – automated extraction
RNA extractions – automated extractions
Nucleic acid concentration determination
(HGT + GRN)
UV spec – used for biodistribution and vector shedding concentration determination so we can test 1 µg DNA where possible and to assess qualityUV spec – used for vector shedding as for preclinical
PicoGreen/RiboGreen nucleic acid determination – used for VCN in order to provide a more accurate copy number quantity
Plasmid linearization /digests
(HGT + GRN)
Used to cut plasmids as linear plasmid provides more accurate quantitation standardUsed to cut plasmids as linear plasmid provides more accurate quantitation standard
PCR assay design
(HGT + GRN)
Required for all methods if there is no sponsor-supplied methodRequired for all methods if there is no sponsor-supplied method
Standard PCR and agarose gel
(HGT + GRN)
Only used as required during development to look at DNA/RNA quality alongside UV specOnly used as required during development to look at DNA/RNA quality alongside UV spec
PCR assays
(HGT + GRN)
Absolute and relative quantification as detailed previouslyAbsolute and relative quantification as detailed previously
Automated liquid handling
(HGT)
To add additional capacity and precision as requiredTo add additional capacity and precision as required

Table 3: Labcorp Molecular Bioanalytical Services product lines

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