Activity in RNA-based therapeutics development has reached an all-time high & there is a large need for trusted, rapid analytical methods.
Avance Biosciences™ brings seasoned GLP- and GMP-compliant assay development, assay validation, and testing services to the exploding world of RNA therapeutics. The development and production landscape for mRNA vaccines and other RNA-based therapeutics is busier than ever. The success of the mRNA COVID-19 vaccines has served as an important validation of the safety and efficacy of this approach and demonstrated the flexibility and speed with which an RNA drug can address an unmet need. Drug developers are now using mRNA vaccines to address a broad array of new therapeutic areas, from Zika to cancer. Consequently, there is a considerable need for accurate, inventive RNA therapeutics analysis and expertise to keep up with the ever-evolving regulatory environment.
New Challenges for the RNA Therapeutics World
RNA-based drugs are distinct from small molecules and other biologics, presenting new analytical challenges and uncertain regulatory standards. In addition, the unveiling of multivalent mRNA vaccines adds the need for sophisticated assay development and molecular biology expertise. With the field growing and progressing so quickly, speedy mRNA characterization, pre-clinical/clinical testing, QC, and lot release are necessary to compete in the competitive marketplace.
Visionary Analytical Solutions, Expertly Executed
At Avance, we are experts at designing, developing, and validating molecular biology assays for RNA therapeutics development and manufacturing. That means faster and more reliable results and innovative solutions to your analytical challenges. We’ve worked at the leading edge of RNA-based therapeutics for a long time and have developed an extensive portfolio of GLP- and GMP-compliant assay services that surpass regulatory requirements.
Our Extensive Portfolio of RNA Therapeutics Analysis Services
We offer a variety of services that can provide a holistic view of your RNA therapeutic.
| Tests | Descriptions |
| mRNA DS/DP Testing (CGMP) | |
| ID | Confirm the sequence of mRNA by sequencing cDNA by Sanger and NGS. |
| Size | Determine mRNA size using CE, HPLC, Bioanalyzer, and/or northern blotting methods. |
| Ratio Testing | Determine the ratio of mRNA in a mixture using RT-qPCR or ddPCR. |
| Residual Plasmid Testing | qPCR-based assay to detect potential plasmid contamination. |
| Quantification | Quantify mRNA using UV Spectroscopy, RT-qPCR, or ddPCR. |
| Protein ID | IVT in cell-free medium and detection of the resulting protein using Western blot/ELISA. |
| Encapsulation Efficiency | Determine mRNA/LNP encapsulation efficiency using RT-qPCR or ddPCR. |
| dsRNA Detection | Detect various dsRNAs using immunoblotting, native and denaturing gel electrophoresis. |
| Potency Assay | Develop and validate a custom IVT assay to determine mRNA potency. |
| Stability Assay | Develop and validate a custom assay to evaluate the long-term stability of mRNA. |
| Mycoplasma Testing | qPCR-based mycoplasma testing. |
| Endotoxin Testing | Test potential endotoxin contamination using Limulus amebocyte lysate (LAL) method. |
| Custom Assays | Develop or tech transfer custom assays from clients and validate/verify the assays for GMP testing. |
| Preclinical/Clinical Testing (GLP or non-GLP) | |
| mRNA/LNP Biodistribution Study | Develop and validate RT-qPCR and/or ddPCR assays and test tissues/blood from various animal models under GLP or non-GLP. Recovery will be evaluated with spiked mRNA, and the RNA standard curve will be used to correct RT efficiency. The standard curve method will be used. |
| mRNA Expression Analysis | Develop and validate RT-qPCR and/or ddPCR assays and test human bodily fluids for mRNA expression. ΔΔCt method or standard curve method will be used depending on the nature of mRNA. |
| mRNA Human PK Study | Develop and validate RT-qPCR and/or ddPCR assays and test human bodily fluids for mRNA expression. ΔΔCt method or standard curve method may be used. |
| E. coli Cell Bank and Plasmid Testing (GMP) | |
| Lytic phage detection | Detect potential lytic phage contamination in E. coli cell banks. A positive control is used to evaluate the assay’s validity. |
| Lysogenic phage detection | Determine the presence/absence of lysogenic phage in E. coli cell banks with Mitomycin C induction. A positive control is used evaluate assay validity. |
| Strain Identification | Various assays to confirm the identity of DH10β, K12, B, BL21, Stabl3 cell lines, as well as RecA and LacI genotyping. |
| Species ID | API 20E test to confirm the species of the cell bank. |
| Gram Staining | Differentiate Gram Positive from Gram Negative bacteria by staining with dyes. |
| Viability Testing | A cell line sample is stained with trypan blue, and the percentage of viable cells is reported. |
| Purity Testing | Aerobic and anaerobic culture to detect potential bacterial and fungal contamination. Various bacteria and fungi are used as controls. |
| Marker Retention Testing | Percentage of cells that contain a selectable marker, such as an antibiotic-resistant gene. |
| Plasmid ID | Double-stranded Sanger sequencing or NGS for full or partial plasmid sequence confirmation. |
| Plasmid Copy Number | Using qPCR, quantify copies of plasmid per cell for characterization and genetic stability evaluation. |
| Restriction Digest | Restriction mapping for plasmid identification and genetic stability evaluation. |
Deep Industry Experience Expediting Analysis to Fast-Track Your Path to Market
We’ve worked with pioneers in the world of RNA medicines and helped rapidly jettison these potent therapeutics from the bench to a household name.
Our experts have developed mRNA analytical methods for mRNA vaccines and emerging approaches to gene editing, with CRISPR-Cas mRNA and gRNA co-delivery in LNPs.
We also have analytical expertise with different delivery vehicles, including LNPs, polymer-based nanoparticles, and more.
We have more than two decades of experience providing advanced genomics services to the pharmaceutical, biopharmaceutical, and biotechnology industries.
At Avance, we are your true collaborative partners, helping create a scientific and operational roadmap that helps you meet your research, clinical, and commercial goals.
Our Customers Say…
From the preliminary conclusion of this work, we are already pleased to thank you for your customer-oriented approach and proactive communication in the course of this study. We are happy to see the profound difference in business mindset between your organization and our previous vendor…
Project Manager, Belgium
Thank you so much for successfully completing this important project for us on time. We are very satisfied with the final report and thank you for taking the extra effort to customize the report format. We will definitely use your lab for future projects.
Program Manager, California
It has been a pleasure working with you and your team. The project was carried out to the highest standard and delivered in a timely manner. I will definitely recommend Avance Biosciences™’ services to colleagues and friends.
Senior Scientist, Singapore
When you partner with Avance Biosciences™, you gain a CRO partner that is creative, collaborative and dedicated to sound science with a focus on the regulatory requirements our partners require. Contact our technical staff to discuss how we can support you in your project!
Dedication to Quality
The Avance Biosciences™ team is committed to strict adherence to GLP and CGMP regulations enacted by the US, European, Japanese, and other international regulatory agencies.
Extensive Experience
Our team has extensive knowledge and experience working with scientists, QA/QC professionals, and project managers from over 100 pharmaceutical and biotechnology companies and organizations throughout the world.
Open Communication
Transparency and integrity are two of our core values. Our well-trained, friendly, and professional study directors and project managers strive to complete your projects on-time with open communication channels and to your specifications.
Cutting Edge Science
Avance Biosciences™’ GLP/GMP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, digital PCR, Sanger sequencing, next generation sequencing, and more.