The development of mRNA as a therapeutic modality has fundamentally redefined modern vaccinology. Offering unprecedented speed, flexibility, and a high degree of tunability, mRNA vaccines leverage the host cell's own machinery to produce the target antigen in situ, resulting in robust and comprehensive immune activation. CD BioGlyco is an expert biology specialist, pioneering high-quality, end-to-end solutions for mRNA-based vaccine development. Our services are designed to navigate the complexities of design, synthesis, purification, and delivery, ensuring your vaccine candidate progresses rapidly from concept to clinic. We are committed to translating groundbreaking immunological science into clinically relevant, high-performing drug products.
The success of any mRNA vaccine hinges on mastering two critical pillars: the integrity and translation efficiency of the mRNA molecule and the efficacy of the delivery system. We employ proprietary and industry-leading technologies to achieve superior product quality.
Vaccine development commences with antigen sequence design and optimization, including UTR and codon optimization, plus nucleoside modifications like m1Ψ to enhance expression. A high-quality DNA template is then prepared for the in vitro transcription (IVT) reaction, where mRNA is synthesized and capped. The crude mRNA is purified using chromatography and filtration to remove impurities such as DNA template, enzymes, and dsRNA. Subsequently, the mRNA is encapsulated into lipid nanoparticles (LNPs) via microfluidics, ensuring high encapsulation efficiency and stability, followed by sterile filtration. Finally, the product undergoes comprehensive analytical testing to confirm identity, purity, potency, and other critical quality attributes.
Expert computational and biological refinement of the mRNA sequence to enhance translational capacity, minimize secondary structure formation, and tune immunogenicity profiles.
High-quality, linearized plasmid DNA production for IVT. Includes sequence verification and removal of residual contaminants.
Incorporation of canonical and modified nucleosides, co-transcriptional or enzymatic capping, and precise polyadenylation to ensure superior performance and stability.
Multi-mode chromatographic separation and filtration to achieve exceptional purity, ensuring contaminants like dsRNA are below industry-leading thresholds for enhanced safety and efficacy.
Custom LNP composition screening, microfluidic manufacturing, and process development to optimize particle size, PDI, zeta potential, and encapsulation efficiency.
Journal: Pharmaceutics
IF: 3.4
DOI: 10.3390/vaccines9020097
Published: 2021
Results: This review article provides a comprehensive update on the development of saRNA vaccines, a next-generation vaccine platform. It explains that saRNA vaccines maintain the advantages of conventional mRNA vaccines—such as rapid, cell-free manufacturing and modular design—but require a significantly lower dose because the RNA encodes its own replication machinery, leading to amplified antigen production within host cells. The authors detail the four critical pillars for saRNA vaccine design: antigen selection, vector engineering, delivery systems (notably lipid nanoparticles), and manufacturing processes. The article highlights the application of saRNA technology against various pathogens, including SARS-CoV-2, influenza, and HIV, and discusses ongoing clinical trials. It concludes that while saRNA vaccines hold immense promise for responsive pandemic control, challenges remain in optimizing stability, reducing required doses, and minimizing reactogenicity.
We partner with biopharma companies to design and optimize mRNA constructs targeting infectious diseases. Our research focuses on rapid antigen prototyping for seasonal pathogens (like influenza and RSV), emerging viruses, and neglected diseases, accelerating the early-stage development of vaccine candidates.
Our services support the research of mRNA-based cancer vaccines. We conduct preclinical studies on vaccines encoding tumor-associated antigens (TAAs) and neoantigens, providing partners with data on eliciting targeted immune responses for both personalized and off-the-shelf immunotherapy approaches.
We investigate the use of mRNA as a research tool for producing proteins in vivo. Our collaborative R&D efforts focus on modeling treatments for monogenic disorders, metabolic diseases, and other conditions where transient protein expression offers a potential research pathway.
Our platform is utilized to research bespoke therapeutic solutions. We work with partners to develop and test patient-specific vaccine regimens and study combination strategies with other agents in a preclinical setting to evaluate potential synergistic effects.
We conduct applied research to adapt mRNA technology for animal health. This includes the design and testing of vaccines for companion animals and livestock, supporting partners in developing solutions for veterinary diseases and zoonosis control.
Our research includes pioneering novel approaches where mRNA encodes therapeutic antibodies or immunomodulators. We perform proof-of-concept studies for this "passive immunization from within" strategy, providing partners with early-stage research data.
We specialize in aggressively reducing critical impurities. Our rigorous downstream process ensures exceptionally low levels of dsRNA (Residual Double-Stranded RNA), which correlates directly with reduced reactogenicity and enhanced translational performance.
Our integrated platform combines advanced sequence optimization and microfluidic LNP manufacturing under one quality system. This holistic approach dramatically shortens development timelines, allowing your program to move faster toward key milestones.
Beyond conventional mRNA, we offer tailored development of saRNA, which requires significantly lower doses due to its replication capability, maximizing therapeutic value. Our custom LNP library and formulation expertise ensure the best delivery vehicle for your specific application.
We have built a vertically integrated manufacturing platform designed for seamless scale-up from preclinical to commercial scales. Our processes are rigorously characterized and controlled, ensuring batch-to-batch consistency and reliable supply to meet your program's evolving demands.
Our investment in cutting-edge analytics goes beyond standard assays. We employ advanced techniques for deep structural characterization of mRNA and in-depth profiling of LNP critical quality attributes, providing you with an unparalleled level of product understanding.
Our commitment extends to continuous platform improvement. We actively pioneer novel lipid chemistries and formulation strategies aimed at enhancing targeting efficiency and broadening the therapeutic window for next-generation applications.
— Dr. Li, Principal Investigator, Vaccine Research Laboratory
— Manager Chen, Program Director, Infectious Disease Therapeutics
— Scientist K., Senior Research Scientist, Oncology Development Group
While our mRNA-based vaccine development service focuses on cutting-edge nucleic acid platforms, we recognize the continued importance of traditional vaccine approaches. For conjugate vaccine development, our One-stop Solutions for Polysaccharide Conjugation provide comprehensive support encompassing Carrier Protein design, Polysaccharide Antigen Production, and advanced Conjugation Technologies to create effective glycoconjugate vaccines.
CD BioGlyco offers an unparalleled, integrated mRNA-based vaccine development service, underpinned by expert knowledge, advanced LNP technology, and a commitment to delivering superior product purity and comprehensive analytical data. Contact us to advance the next generation of vaccines and nucleic acid therapies.
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