Vaccine Development Solutions

For new generations of vaccines
Raw materials several grades available, including GMP

Overview Workflow Solutions Industry Insights Resources

Application Solutions » Vaccine Development

Overview

Vaccines have played a major role in protecting human health as one of the main means of controlling infectious diseases. More than 20 high-risk diseases can be currently prevented through vaccination. Additionally, since the cost of vaccination is far lower than the high medical expenses incurred after the disease occurs, vaccines are a health investment with one of the highest rates of return. The importance of vaccines was highlighted during the outbreak of COVID-19, when developing a vaccine was considered one of the most important ways to end the pandemic.

With world-renowned advanced technology platforms and rich production experience, GenScript provides synthesis services for gene, plasmid, peptide, protein, etc., available in several vaccine production grades, including GMP.

Application Solutions

Vaccine Development Workflow

Antigen
Discovery 1

Vaccine
Development 2

Pre-clinical
Study 3

Clinical
Development 4

Antigen Discovery

Pathogen Study

In the discovery stage, quickly obtaining the pathogen gene sequence is usually the first critical step for developing vaccines and therapeutic drugs. The next step is to study the mechanism of the pathogen's entry into cells and its structure, function, and immunogenicity. The epitope (also known as antigenic determinant) is the part of the antigen recognized by the immune system that stimulates the immunogenic response. Therefore a deep understanding of the epitope distribution and types provides an essential foundation for vaccine development.

Genome Sequencing

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Antigen Identification & Selection

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Antigen Epitope Study

Peptide Library Services

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Tumor Study

With the development of immunology research, scientists and physicians have discovered new uses for vaccines, such as to treat some intractable diseases. Therefore, vaccines can have both preventive and therapeutic functions. Therapeutic vaccines belong to specific active immunotherapy, especially tumor therapeutic vaccines are at an important stage of development.

Tumor Specific Antigen Screening

Neoantigen Peptide Synthesis Service

Vaccine Development

Through the years, vaccine technologies have undergone many evolutions, and new vaccine types have been developed. GenScript provides comprehensive solutions for the development of new generations of vaccines, such as recombinant protein vaccines, peptide vaccines, mRNA vaccines, DNA vaccines, and viral vector vaccines.

mRNA Vaccine

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Recombinant Protein Vaccine

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DNA Vaccine

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Viral Vector Vaccine

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Peptide Vaccine

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Pre-clinical Study

In response to vaccination, the immune system develops innate and adaptive immune responses. The innate immune response is triggered immediately to new pathogens not present in the host. The more specific adaptive immune response is developed later and consists of antibody and cellular response. Therefore the level of the vaccine antigen is important in order to generate sufficient adaptive immune response. GenScript can support vaccine development as well as the development of vaccine-specific measuring assays such as neutralizing ELISAs and pseudovirus neutralization tests.

mRNA Vaccine

Plasmid Linearization

IVT mRNA Production

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Recombinant Protein Vaccine

Mammalian CHO Expression

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DNA Vaccine

GenCircle dsDNA Vector

GMP Grade

Plasmid Preparation

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Viral Vector Vaccine

AAV Vector Packaging

Lentiviral Vector Packaging

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Antigen Expression Test

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Humoral Immunity Evaluation

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Cellular Immunity Evaluation

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Clinical Development

The focus of clinical trials is to investigate the safety and effectiveness of vaccines, including the evaluation of vaccine protection efficacy and the exploration of the correlation between immunogenicity indicators and protection. Therefore vaccine samples for clinical trials should be produced under GMP conditions. GenScript can provide RUO and GMP grades of key materials used in vaccine development in research and clinical stages to fully support you in successfully launching vaccines.

mRNA Vaccine

Plasmid Linearization

IVT mRNA Production

GMP Grade

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Recombinant Protein Vaccine

GMP Cell Banking

Mammalian CHO Expression

Biologics GMP Grade

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DNA Vaccine

GenCircle dsDNA Vector

GMP Grade

Plasmid Preparation

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Viral Vector Vaccine

AAV Vector Packaging

Clinical GMP Grade

Lentiviral Vector Packaging

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Peptide Vaccine

Peptide Synthesis

GMP Grade

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Analysis and Manufacturing

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GenScript supports vaccine development helping you meet different quality requirements in all production stages, from early research to clinical trials.

	Basic Research	Early Drug Discovery		Preclinical Studies	IND	Phase 1	Phase 3
GenCircle dsDNA Vector	Research Grade				GMP Grade
Plasmid Preparation	Research Grade	Industrial Grade		Preclinical Grade	IND CMC	GMPro Grade	GMP Grade
Plasmid Linearization	Research Grade		Preclinical Grade		IND CMC	GMPro Grade	GMP Grade
IVT mRNA Production Service	Research Grade		Preclinical Grade		IND CMC	GMP Grade
Protein Expression Service	TurboCHO™- HT	TurboCHO™-Express		TurboCHO™- HP	IND CMC	Biologics GMP Grade
AAV Vector Service	Research Grade			Pro Grade	AAV CMC	Clinical GMP Grade
Lentiviral Vector Service	Research Grade			Pro Grade	LVV CMC	Clinical GMP Grade	GMP Grade
Peptide Synthesis	Research Grade				GMP Grade

Industry Insights

On-Demand Webinar: Self-Amplifying RNA in Vaccines and Beyond^New
A recent breakthrough in RNA vaccine technology is the development of self-amplifying RNAs. In this webinar, Dr. Mark Shulewitz, Field Application Scientist at GenScript, explains what self-amplifying RNAs are, how they differ from conventional RNA and their potential impact on shaping the next generation of RNA vaccines and other therapeutic applications.

Key Takeaways:
- IVT RNA has successfully been used for vaccines.
- Linear mRNA (conventional mRNA), Circular RNA (circRNA), self-amplifying RNA (saRNA) are the 3 modalities of RNA being explored for therapeutic applications.
- Self-amplifying RNA (saRNA) has higher and more prolonged protein expression than conventional mRNA.
- saRNA has great potential for vaccine and other therapeutic development.
- saRNA is in development for vaccines and can also be applied to other RNA-based applications such as protein replacement therapy.
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A Neoantigen Vaccine and Pembrolizumab Show Promise in Hepatocellular Carcinoma

The effectiveness of immune checkpoint inhibitors (e.g., pembrolizumab) against metastatic melanoma has been well-established. However, their use as standalone treatments for other cancer types, such as advanced hepatocellular carcinoma, has shown limited success. As a result, recent clinical studies have increasingly focused on evaluating the effectiveness of combining immune checkpoint blockers with other treatment methods.

The research published and reported at ASGCT 2024 demonstrated a clinical benefit for hepatocellular carcinoma patients from combined treatment with the anti-PD1 inhibitor pembrolizumab and a personalized cancer vaccine. The findings support that this approach could improve outcomes over those achieved with pembrolizumab monotherapy by expanding and diversifying the population of reactive T cells that can infiltrate the tumor site.

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What’s the role of microRNA in vaccine development?

microRNAs (miRNAs) are small, non-coding RNA molecules that play crucial roles in regulating gene expression. The 2024 Nobel Medicine Prize was awarded to Victor Ambros and Gary Ruvkun for discovering them. However, there’s no microRNA-based drug on the market yet. Can miRNAs be used for vaccine development? Here’s a summary of miRNA potential functions from published papers for vaccine development.

1. Adjuvant development: Incorporation of miRNAs as adjuvants into DNA vaccine constructs can ameliorate innate antiviral pathways which usually limit maximal antigen expression.

In this article, vaccinating BALB/c mice with a DNA vaccine vector delivering miRNA targeting PERK, but not PKR, was able to augment HIV-1 envelope (Env) antigen-specific T cell immunity.

2. Immune response modulation: miRNAs can influence the innate and adaptive immune responses by regulating the expression of genes involved in these processes. This can help in designing vaccines that elicit stronger and more targeted immune responses.

MicroRNA 155 (miR-155) deficiency in dendritic cells impairs their maturation, migration, cytokine production, and ability to activate T cells. In this article, dendritic cell vaccine overexpressing miR-155 exhibited enhanced functions in response to breast cancer antigens.

3. Biomarker discovery: miRNAs can serve as biomarkers to monitor the effectiveness of a vaccine. Changes in specific miRNA expression levels can indicate how well a vaccine is working, allowing for more precise adjustments in vaccine design and administration.

After COVID-19 vaccination, data in this article suggest a potential of circulating extracellular vesicles (EV) miRNAs as biomarkers for vaccine efficacy and adverse reactions. EV miR-92a-2-5p levels in sera were negatively correlated with degrees of adverse reactions, and EV miR-148a levels were associated with specific antibody titers.

Vaccine Development Resources

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