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Products

Virus-Like Particles (VLPs) Service

OverviewResearch-Grade ServicesCDMO ServicesContact UsFAQ

VLP Overview

In recent years, Virus-Like Particle (VLP) technology has sparked revolutionary advances in vaccine development, gene therapy, nano-drug delivery, and tumor immunotherapy due to its unique biomimetic structure and biosafety. Leading international research teams have successively introduced VLP-based delivery systems such as VLP-mRNA, SEND, and eVLP.

As a global leader in VLP technology services, Creative Biogene leverages over a decade of technical expertise, international GMP production qualifications, and a comprehensive service system to provide end-to-end solutions for research institutions and pharmaceutical companies—from basic research to industrial production, accelerating the clinical translation and commercialization of innovative therapies.

VLP Overview

VLPs are nanoscale particles (20-200 nm) formed by the molecular self-assembly of one or more viral structural proteins. Their morphology closely resembles natural viruses, exhibiting icosahedral symmetry, rod-shaped, or enveloped complex structures. The core characteristic of VLPs is their complete lack of viral genome while retaining the viral particle's immunogenic epitopes and eliminating replication risks, making them widely recognized as an ideal platform for next-generation vaccines and delivery vectors. Since their first observation in hepatitis patient serum in 1968, VLP technology has progressed from basic research to commercial applications, with successful market launches of HPV, HBV, and HEV vaccines validating their clinical translation potential.

Figure 1. A schematic diagram of the classification of different virus-like particles Figure 1. A schematic diagram of the classification of different virus-like particles

VLP Structural Classification and Functional Characteristics

The diversity of VLPs stems from their structural protein assembly modes and functional modifications, primarily classified as follows:

Classification Dimension	Type	Structural Characteristics	Representative Virus Examples
Envelope Presence	Enveloped VLPs	Contains lipid bilayer membrane from the host, integrating viral surface glycoproteins	Influenza virus (HA/NA), HIV (gp120/gp41)
Envelope Presence	Non-enveloped VLPs	Composed only of capsid proteins, without lipid membrane structure	HPV (L1 protein), HBV (S antigen)
Structural Complexity	Single-layer VLPs	Self-assembly of a single structural protein forming virus-like particles	Norovirus (VP1), Circovirus
Structural Complexity	Multi-layer VLPs	Coordinated assembly of multiple structural proteins, forming multi-layered shell structures	Rotavirus (VP2/VP6/VP7), Adenovirus
Antigen Display Mode	Chimeric VLPs	Using VLP vectors to display heterologous antigen epitopes or protein domains	HBV core particles displaying HPV E7 peptide, Classical swine fever virus E2
Antigen Display Mode	Mosaic VLPs	Integration of structural proteins from different virus subtypes co-expressed to form composite VLPs	Influenza virus H5/H7 subtype mixed HA expression

Core Advantages of VLPs

High immunogenicity: VLP surface antigens can efficiently activate B-cell and T-cell immune responses, inducing neutralizing antibodies and cellular immunity.
Excellent safety: Non-infectious, suitable for pregnant women, elderly populations, and immunocompromised individuals.
Structural designability: Display heterologous antigens through genetic engineering or chemical modification, or encapsulate drugs, nucleic acids, and other molecules.
Delivery efficiency: Nanoscale size similar to natural viruses, capable of penetrating tissue barriers and targeted delivery.

Application Areas and Latest Developments in VLP Technology

Currently, VLP technology applications primarily focus on two major directions: vaccine development and gene delivery systems, serving key areas such as infectious disease control and gene therapy.

Core Platform Technology for Vaccine Development: VLPs, due to their high mimicry of viral structures, can efficiently activate humoral and cellular immune responses, becoming the technological foundation for several marketed vaccines (such as hepatitis B, HPV, and hepatitis E vaccines). In new vaccine development, VLP vaccines represented by SARS-CoV-2 can form complete structural viral shells in mammalian cells through co-expression of S, M, E, and N proteins, effectively activating CD4⁺/CD8⁺ T-cell and B-cell immune responses, possessing excellent protective potential and clinical translation value.

Emerging Tool for Gene Delivery Systems: VLP applications in gene therapy continue to break through, showing tremendous advantages, particularly in non-viral vector delivery. Through engineering design, they can carry various nucleic acid drugs (such as mRNA, siRNA, gene editing tools, etc.), achieving directional delivery, low immunogenicity, and high expression efficiency. Currently, multiple cutting-edge studies have constructed various functionalized eVLP platforms.

VLP Research-Grade Services

VLPs excel in vaccine development and become core tools for viral component research and gene delivery. Creative Biogene, with rich recombinant expression experience and molecular construction capabilities, provides comprehensive, modular VLP research-grade services to help customers efficiently complete POC verification and early-stage results translation.

VLP Characterization Services

We provide one-stop services, from VLP design, expression, and purification to systematic characterization, which are suitable for vaccine development, immunodetection, and structural-functional research.

Structure and purity analysis: SDS-PAGE, LC-MS, TEM, Cryo-EM
Particle size and stability assessment: DLS, AF4-MALS, CD, DSC
Safety testing: endotoxin, host residual protein/nucleic acid

Ensuring VLP quality consistency and application feasibility, supporting basic and translational research.

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Vaccine Development Services

Leveraging VLPs' natural immune stimulation advantages, we provide comprehensive services from vaccine antigen screening, construction, animal experiments to immune assessment.

Rapid construction of multivalent or chimeric VLP vaccines
High-throughput antibody/antigen screening and neutralization assessment
Verification of immunogenicity and protective effects in animal models
Support for infectious disease and tumor immunotherapy development

Meeting personalized vaccine design and verification needs, accelerating progress from development to clinical translation.

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Membrane Protein Drug Screening Platform

Based on Lipoparticle technology, membrane proteins are stably expressed on VLP surfaces, preserving original conformation and function, widely applied in:

Antibody screening and affinity assessment (SPR/BLI/ELISA)
Ligand binding kinetics and structural-functional analysis
Drug mechanism of action and throughput screening model construction

Supporting customer-defined membrane protein types and expression levels, serving as an ideal platform for target discovery and antibody drug development.

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VLP-Based Gene Delivery Services

Using modifiable VLP platforms, we construct non-viral gene delivery systems with targeting and tissue selectivity.

Detoxified structure ensuring delivery safety
Support for encapsulation of siRNA, mRNA, CRISPR elements, and other nucleic acid payloads
Capability to install surface ligands for targeted transport
Applications in tumor therapy, vaccine delivery, cell editing, and other fields

Providing customers with customized, low immunogenicity, high expression efficiency delivery solutions.

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RNA Phage VLP Technology Services

Creative Biogene offers specialized services in the design, production, and application of RNA phage-derived VLPs. These VLPs are engineered from single-stranded RNA bacteriophages such as AP205, MS2, Qβ, Beihai32, and PQ465, known for their structural stability and ease of modification, widely applied in:

Custom vaccine antigen design and immune response evaluation
RNA loading (mRNA/siRNA/CRISPR) for gene therapy model development
Functionalized VLP construction for diagnostic probe generation

Supporting client-defined cargo types, loading strategies, and display formats, enabling flexible solutions for vaccine development, RNA delivery, and molecular diagnostics.

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Core Advantages

Your Partner in Advanced VLP Engineering

Creative Biogene delivers industry-leading VLP solutions with high safety, precision customization, and scalability for advanced virology and vaccine innovation.

Comprehensive Membrane Protein Target Library

40+ VLP products
Covers GPCRs, transmembrane proteins, receptor targets

High-Fidelity Structural Reconstruction

Expression systems: HEK293, CHO, Insect (Baculo)
Native conformation & orientation preserved
Supports antibody screening & structural studies

Customizable Development Workflow

Full process: gene → protein → functional validation
Supports tag fusion, expression optimization, activity testing

High Purity · High Stability · High Reproducibility

Excellent antigenicity & batch consistency
Ideal for flow cytometry, immunodetection, and immunization

VLP CDMO Services

In today's rapidly developing landscape of vaccines and biological therapeutics, Virus-Like Particles (VLPs) have become one of the core platforms for multiple vaccine developments due to their highly biomimetic nature, safety, and strong immunogenicity. As a CDMO service provider focused on VLP product development and production, Creative Biogene is committed to providing global clients with one-stop VLP CDMO solutions from process development and clinical sample preparation to commercial production, comprehensively supporting the industrialization process of vaccines, biologics, and gene therapies.

Process Analysis & Feasibility Assessment

Through systematic evaluation at the initial project stage, we provide clients with scientific and comprehensive feasibility analysis reports, clarifying the current development stage, key process nodes, and potential risks:

Evaluation of existing VLP design and expression systems
Clinical and commercialization potential analysis
Process flow diagram analysis and data analysis
Risk & Gap Analysis
Technology Scouting & Selection
Cost Modeling and financial assessment

This phase is completed within 6-8 weeks, laying a solid foundation for the next stage of development and technology transfer.

Process Design & Development

VLP development faces multiple challenges, including high requirements for expression system folding and assembly capabilities, production yield fluctuations and consistency control difficulties, separation and purification challenges, and lack of unified quality control standards. Creative Biogene, combining Continuous Bioprocessing Manufacturing (CBM) concepts and Advanced Process Control (APC) strategies, has achieved significant breakthroughs in improving production efficiency and ensuring product quality consistency.

Our process development team builds customized VLP process development plans based on client needs, from prokaryotic/eukaryotic expression system selection and upstream expression optimization to downstream purification strategy establishment, ensuring controllable, scalable, and transferable processes:

Raw Materials and Plasmid Development

VLP construction plasmid design and custom production (including HQ/GMP grade)
Stable transfection cell line construction and characterization
Transfection/infection condition optimization (supported by high-throughput platform)

Upstream Process Development (USP)

Expression system screening (baculovirus-insect cell systems, yeast systems, mammalian cell systems, etc.)
Batch expression process optimization (reactor conditions, culture media, feeding strategies)
Scalability verification (from laboratory small-scale to 30L/200L/2000L)

Downstream Process Development (DSP)

Clarification and concentration process design (TFF, depth filtration, etc.)
Chromatography process development (SEC/IEX/HIC/immunoaffinity)
Buffer system and formulation optimization
VLP structural integrity and multivalent assembly detection

Process Scalability Verification

Process window exploration and scale-up verification
Prototype process pilot transfer and stability testing
Non-GMP/toxicology sample preparation

GMP Manufacturing Services

We have two cGMP-compliant production facilities equipped with advanced single-use bioreactors, fixed-bed systems, and high-performance DSP platforms that can provide full-process production support from preclinical to commercialization for different types of VLP products:

GMP-grade cell bank (MCB/WCB) establishment and storage
GMP-grade VLP bulk production
Quality control standard establishment and analytical method transfer
Fill & Finish and lyophilization process development
Storage and transportation support (cold chain management)
Stability studies (compliant with ICH guidelines)
Complete GMP release and compliance documentation support

We rely on a comprehensive CMC support system and flexible production capabilities to meet diverse scale requirements (from 50L to 2000L), with high-standard quality control processes for batch-to-batch consistency.

Quality System & Regulatory Support

Creative Biogene has built a comprehensive quality management system compliant with international standards including FDA, EMA, and NMPA, fully covering the entire CDMO service process:

Implementation of QbD concepts compliant with ICH Q8/Q9/Q10
Document management and batch record integrity
Original data traceability and electronic system compliance (21 CFR Part 11)
Analytical method development, transfer, and validation
Quality control projects covering protein quantification, VLP structural analysis, residual detection, host DNA/protein detection, endotoxin testing, etc.
Regulatory consultation and IND/CTA/MAA application support services

Platform Highlights

Modular development system

Providing process templates, modular process design, and full-service production services, flexibly adapting to different project progress and strategies

Highly integrated automation platform

Supporting from micro-screening to kilogram-scale production, customizable process paths, high degree of automation, effectively reducing human error

Continuous bioprocessing system

Integrating perfusion processes and new TFF membrane systems, significantly improving VLP purification efficiency and recovery rates, and optimizing supply chain response capabilities

Integrated delivery platform

Achieving full-process integration from plasmid construction, GMP cell bank establishment, clinical-grade pilot production to commercial GMP production

Rich delivery experience

Complete service records for multiple VLP vaccine projects from IND filing to Phase III clinical production, with clear pathways and controllable quality

Rapid response

Customized projects can complete process development to toxicology batch delivery in as fast as 5 months, significantly compressing development cycles

Our Workflow

1Project initiation and information alignment

2Feasibility analysis and process assessment

3Custom development plan design and execution

4Pilot transfer and non-GMP batch preparation

5GMP process validation and scale-up production

6QA/QC management and compliance support

7Fill and finish, inspection, and delivery

Contact Us

Whether you are in the early stages of antigen screening or facing challenges in process scale-up and clinical application, Creative Biogene can provide customized solutions. We integrate cutting-edge technology, mature processes, and strict quality control to fully support your project.

Contact our professional team now to obtain VLP technical solutions and project evaluation, and jointly promote the research and commercialization of innovative therapies!

FAQ

Q1: I'm concerned about the stability or assembly efficiency of VLPs. Can you guarantee performance?

A1: Absolutely. With extensive experience and multiple expression platforms (mammalian, insect, yeast), we can select and optimize the best system based on your target protein. During the early stages, we perform a full range of structural and quality assessments (TEM, DLS, SDS-PAGE) to ensure high assembly efficiency and batch-to-batch consistency.

Q2: What advantages do VLPs offer over traditional protein vaccine platforms?

A2: VLPs offer superior immunogenicity by mimicking the native virus structure and allowing multivalent antigen display or molecular delivery. Our platform also supports site-specific modifications, enabling targeted immune responses or gene delivery applications beyond what traditional vaccines can achieve.

Q3: I already have my own plasmid. Can I just outsource VLP expression and purification?

A3: Yes, definitely. Our services are fully modular. You can choose only the components you need — such as expression + purification, purification only, or structural validation — without starting from scratch. This helps save time and budget.

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