How Can We Help?
Skip to content
Lab technician with dropper into lab test tubes

Intermediate Molecules: ADC and Oligonucleotide Analysis Services for Therapeutic Development

You can now request quotes for our research services on BioIVT.com!

Whether you need a single assay or a complete ADME program, BioIVT’s experts will help design and implement the appropriate studies for your drug and research objectives. View BioIVT’s comprehensive portfolio of ADME research services.

The application of traditional safety testing for intermediate molecules is an evolving science. The FDA has referred to the January 2020 guidance, “In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions,” as a general framework for conducting in vitro experiments and interpreting data for therapeutic oligonucleotides.

In support of advancing the research and development of intermediate molecules, our Drug Development Solutions Center provides non-regulated bioanalysis of oligonucleotides (oligos), antibody drug conjugates (ADC) and other intermediate molecules (milli-molecules) for quantification of parent drug and/or metabolite concentration in various biological matrices to support ADME (absorption, distribution, metabolism, and excretion)DMPK (drug metabolism and pharmacokinetics), and DDI (drug-drug interaction) studies in drug development.

Antibody Drug Conjugate and Oligonucleotide Analysis Support

Our Medical Analytical Services team has approx. 100 years of combined company experience between our two analytical labs, servicing pharma and biotech entities, academic institutions and even other CROs. In addition to traditional small molecules, we also provide in vitro and in vivo support for intermediate molecules, including antibody drug conjugates and various types of oligos, such as:

  • Oligonucleotide aptamers
  • Antisense oligonucleotides (ASO)
  • CpG oligonucleotides
  • Decoy oligonucleotides
  • Heteroduplex oligonucleotides (HDO)
  • miRNA and siRNA oligonucleotides
Antisense siRNAmirnahdodecoyaptamerCpG
Chemical StructureSingle-stranded
DNA/RNA
Double-stranded RNADouble-stranded RNADouble-stranded
DNA/RNA
Double-stranded
DNA
Single-stranded
DNA/RNA
Single-stranded
DNA
BP Length13-30Around 20Around 2013-30Around 2026-45Around 20
Targets for BindingmRNA
miRNA
mRNAmRNAmRNA
miRNA
Proteins/
Transcription factor
Extra-/intra-cellular proteinsProteins/TLR9

We predominantly provide bioanalysis of intermediate molecules with 14-30mer (molecular weight > 4.5 kDa but < 10kDa) as standalone analysis or as part of ADC and oligonucleotide pharmacokinetics and metabolism studies, such as enzyme linked oligonucleotide assays, oligo pull down assays, ADC and oligonucleotide characterization or stability, uptake assays, oligonucleotide ligation assays, oligonucleotide HPLC analysis, oligonucleotide sequencing mass spectrometry, etc. Learn more about our intermediate molecule analysis services and capabilities below.

Oligonucleotide and Antibody Drug Conjugate Services

  • ADME in mice, rabbits and monkeys
  • Quantitative analysis in various matrices including:
    • CSF/Plasma
    • Tissue
  • Quantitative analysis in various methods including:
    • LC-MS/MS
    • HPLC
    • qPCR
    • Hybridization by ELOSA
    • Hybridization by PALSAR
  • Absorption Study Types include:
    • Single-Dose in Monkeys
    • Repeated-Dose in Monkeys
  • Distribution Study Types include:
    • Intra-organization distribution in Monkeys (single and repeated doses)
    • Plasma Protein Binding (PPB) in Mice and Monkeys (by ultrafiltration)
    • Placental transfer in Mice and Monkys
  • Metabolism Study Types include:
    • Metabolite analysis in young Monkeys (repeated doses – 14 weeks)
    • CYP Inhibition
    • CYP Induction
    • TP Inhibition
  • Excretion Study Types include:
    • Milk excretion by pregnant mice
  • Excel summary of deliverables
  • Electronic data summary outlining analytical method and sample preparation, calibration curve and calculated sample concentrations
Analytical MethodsDetection limitsAdvantagesDisadvantages
LC-MS/MS>100 amol/µL– LC guidelines applicable
– Signals separated from metabolites
– Low sensitivity
– Cumbersome pretreatment
Hybridization
(ELOSA)
>1 amol/µL– LBA guidelines applicable
– High throughputs
– Medium sensitivity
– Low selectivity (unable to separate from metabolites)
Hybridization (PALSAR)>0.01 amol/µL– LBA guidelines applicable
– High sensitivity
– Solves selectivity problem
– Lower throughputs compared to ELOSA
qPCR>0.00002 amol/µL– Much higher sensitivity– Amplification errors, low reproducibility
– Signals cannot be separated from metabolites
– LBA guidelines not applicable

Intermediate Molecule Bioanalysis Instrumentation

Luminex® 100/200TM System
MSD® QuickPlex SQ120TM System

Want more information?

Learn more about SEKISUI Medical and the Drug Development Solutions Center

Tokai in vivo radiolabeling laboratory

Supported Research Services

Read more about the ADME/DMPK and Drug-Drug Interaction studies that are supported by our analytical services

State-of-the-art Tecan instrumentation used by SEKISUI XenoTech scientists