RNA-Based Therapies 

Therapeutic drugs and vaccines with RNA-based structures are relatively new in drug development, and the bioanalytical testing strategies for them are continuing to evolve.  Working with an experienced bioanalytical provider like BioAgilytix is a critical step to a successful preclinical and clinical approach.

Source multiple endpoints with just one service provider for your immunoassay, cell-based, molecular, and LC/MS assay development, validation, and sample testing. This approach helps ensure efficient data delivery for your therapeutic study.

Our scientific teams are well-versed in the unique methods and analytical platforms required for detection of nucleic acid-based therapeutics, such as mRNA, microRNA, siRNA, and aptamers, during both preclinical and clinical testing. Commonly utilized techniques include:

• RT PCR (qPCR or ddPCR) for absolute and relative quantitation
• Hybridization ELISAs
• Ligand Binding Assays
• LC/MS methods
    

Many RNA-based therapeutics include nucleic acid as well as a delivery system such as lipid nanoparticles (LNPs). In addition to PK measurements for the therapeutic itself, BioAgilytix provides immunogenicity for each of the drug components as well as biodistribution assays, biomarker testing, and CMC support for our clients with these types of modalities. Learn more about these service lines here: 

• Humoral immunogenicity (ADA and NAb assays)
• Preclinical biodistribution (RT-PCR)
• Therapeutic protein expression (western blot, LC/MS, or LBA)
• Target protein or gene expression (western blot, LC/MS, LBA, or RT-PCR)
• Delivery system quantification (ex. LNP by LC/MS)
• Biomarker assays
• CMC bioanalytical

Premier suite of bioanalytical platforms to ensure the delivery of precise, robust, and reliable results for a wide range of assessments.

• qPCR/ddPCR
• ELISA
• LC/MS
• Flow cytometry 
• MSD

• Benefit from working with a single team that drives both the assay development and sample testing
• Work with Project Managers who directly coordinate all your critical assay work ensuring on-time deliverables according to your priorities and requirements