mRNA potency analysis service at CD BioGlyco provides a critical bridge between structural integrity and functional performance. While structural characterization confirms the "what" of an mRNA molecule, potency analysis addresses the "how well" by measuring its specific ability to produce a functional protein within a biological system. CD BioGlyco leverages years of expertise to deliver robust, reproducible, and sensitive potency data. We focus on the translation efficiency and the subsequent biological activity of the encoded protein, ensuring that every batch of mRNA meets the stringent efficacy requirements.
As part of our comprehensive therapeutic nucleic acid development platform, specifically under mRNA-based vaccine development and mRNA structural characterization, CD BioGlyco offers a specialized suite of services focused on potency. We understand that mRNA efficacy is determined by a complex interplay of delivery, stability, and translation. Our service scope includes:
We begin by analyzing the target protein's mechanism of action (MoA) to design a potency assay that is biologically relevant and compliant with regulatory expectations.
We identify or engineer the most appropriate cell lines that reflect the mRNA's intended tissue or systemic target, ensuring high transfection efficiency and reproducible readouts.
Utilizing various delivery systems, such as lipid nanoparticles (LNPs) or electroporation, we optimize the entry of mRNA into cells to ensure maximal and consistent translation.
Using our core technologies (e.g., ELISA, flow cytometry, or functional assays), we quantify the expressed protein and measure its specific biological impact within the cellular model.
Our bioinformaticians perform sophisticated statistical modeling to calculate relative potency, EC50 values, and confidence intervals, ensuring the data is statistically sound.
Clients receive a detailed technical report containing all experimental parameters, raw data, processed results, and a professional interpretation of the mRNA's potency profile.
DoI: 10.3390/vaccines13030326
Journal: Vaccines
IF: 3.4
Published: 2025
Results: This study investigates whether a cell-based relative potency assay replaces animal studies for evaluating the respiratory syncytial virus (RSV) mRNA vaccine V171. Six vaccine lots were tested in BALB/c mice (immunized on Day 0 and 21) and in Hep G2 cells. Mouse immune responses were measured via post-dose 1 ELISA and post-dose 2 neutralization assays, while the cell-based assay quantified RSV F protein expression relative to a reference standard. Statistical analysis revealed a significant negative correlation between cell-based relative potency and post-dose 2 neutralizing ED50 (Pearson's r = −0.82; p = 0.047). No significant correlation was found with post-dose 1 ELISA results. The findings support using the cell-based assay for V171's development, lot release, and stability testing, establishing proof-of-concept for replacing animal immunogenicity studies with in vitro assays for mRNA vaccines.
Fig.1 Post-dose (PD1) RSV F-protein-specific ELISA results from the mouse immunogenicity study. (Feller,, et al., 2025)
Infectious Disease Vaccine Development
Potency assays are critical for determining if a vaccine candidate produces sufficient antigen levels to trigger a robust immune response, facilitating the selection of the most effective mRNA sequences.
Oncology Immunotherapy
We help researchers validate mRNA-encoded tumor antigens or checkpoint inhibitors by measuring their expression and functional impact on immune cell activation within specialized cancer cell models.
Protein Replacement Therapies
For rare genetic disorders, our services ensure that mRNA is correctly produced to produce functional enzymes or structural proteins, compensating for missing or defective endogenous proteins with high precision and reliability.
Personalized Neoantigen Vaccines
For personalized cancer vaccines, we provide rapid potency validation of specific neoantigen sequences. This ensures that custom-manufactured mRNA batches meet strict activity thresholds required for stimulating a targeted, specific T-cell response.
High-Sensitivity Detection
We utilize cutting-edge technology to detect low-level protein expression with extreme precision and reliability across various sample types, ensuring that even subtle variations in mRNA potency are accurately captured.
Customizable Assay Development
Our team specializes in tailoring specific bioassays to the unique mechanism of action of each mRNA candidate, providing biologically relevant data that standard assays might overlook.
Expert Scientific Consultation
Our PhD-level scientists provide deep insights into data interpretation, helping clients navigate complex biological results and providing troubleshooting support throughout the entire drug development lifecycle.
Integrated End-to-End Solutions
From initial mRNA design to final potency validation, we provide a holistic approach that simplifies the supply chain and ensures consistency across different stages of development.
"Their ability to develop a custom functional assay for our specific therapeutic protein allowed us to demonstrate efficacy clearly."
– D.F., Director of Analytical Development
"We were impressed by the sensitivity of the reporter assays used. CD BioGlyco helped us identify the most potent mRNA lead from a library of twenty candidates."
– A.T., Principal Scientist
"The technical support and detailed reporting provided by the team exceeded our expectations. They didn't just provide numbers; they provided a biological context that was vital for our project."
– D.K., Senior Researcher
CD BioGlyco is dedicated to advancing the field of mRNA therapeutics by providing world-class mRNA potency analysis services. Our combination of high-end technology and customized approaches ensures that your mRNA candidates are thoroughly validated for biological activity. Please feel free to contact us for detailed information on our services or to request a formal quotation.
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