Assay Development

OneWorld Biotech offers a proven scientific and systematic approach to successful custom assay design and manufacture. We use custom-designed reagents (proteins, antibodies, conjugated antibodies, and cell lines) and can source assay components from third party vendors. OneWorld Biotech has the capability to create a variety of validated assay systems.

OneWorld Biotech Advantage

  • Beginning with an initial consultation to evaluate assay requirements, followed by a thorough scientific review of design options and reagent sourcing and production, we meticulously evaluate every stage of the process until a final method, reagents and validated assay kits are supplied to our client. 
  • OneWorld Biotech applies a Quality by Design approach to all assay development programs. 
  • Our assay management process includes regular client updates, milestone reports and open dialogue throughout the program timeline – client support is our strength.


Our immune reagent support service either produces or sources, as appropriate, antigens, antibodies, and kit components, and then validates and manufactures your assays. Assay formats include ELISA, Dip Stick, Lateral Flow, Bead-based (magnetic, latex and fluorescent) multiplex, and western blot. One of the assays we developed is in clinical use now. Please also see Antibody Support Services.

Cell-based Assays

We develop cell-based assays including primary cell translational assays, cell proliferation, cytotoxicity and custom transgenic cell line development for reporter gene assays, FRET-based studies for protein interaction, receptor binding, and pathway analysis. We recently completed the in vitro evaluation of a cancer drug in clinical trials for effectiveness against other cancer cell lines.

Enzyme Assays

We conduct enzymology studies for reagent development and validation, including analysis of Km, Kcat, Kd, Vmax, IC50, Ki, pH characteristics and solvent tolerance.

DNA- and RNA-based assays

  • Our Molecular Cloning services are a cost-effective way to prepare reagents and develop DNA- and RNA-based assays and include:
  • In vitro RNA and mRNA synthesis for RT-PCR, qPCR and RNAseq spike-in (internal or external), copy number, and reference standards
  • RT-PCR, qPCR, 5’ RACE, 3’ RACE, Exon trapping, S1 mapping, and Northern blotting
  • RNA, mRNA and microRNA isolation, cDNA library construction, and cDNA isolation
  • DNA fragments or plasmids for EMSA (gel shift), copy number, SNP, FISH, and diagnostic purposes
  • Synthetic fragments with unique signature that are patent-free and license-free
  • Species-specific DNA-based assays for rapid identification
  • Contamination detection assays (host cell DNA) used in fermentation and purification processes and serum and other bodily fluids preparation