Vaccine Formulation Development Solution

Creative Biolabs provides leading vaccine formulation development services, focusing on solving modern vaccine immunogenicity challenges, enhancing stability, and ensuring targeted delivery. Our comprehensive solutions cover excipient screening, stable liquid and lyophilized formulations, advanced delivery systems (e.g., nanoparticles and liposomes), and complete adjuvant optimization, helping clients move innovative vaccines safely and efficiently to the clinic.

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How We Solve Core Challenges in Vaccine Development

Successful vaccine formulation relies on the synergistic effect of adjuvants and delivery systems to overcome major obstacles in immunogenicity, stability, and targeting of modern vaccines.

Adjuvant-Driven Immune Enhancement

Modern subunit or nucleic acid antigens have weak immune signals. We select high-efficiency adjuvants (e.g., PRR ligands, CpG) to target and activate innate immune cells, ensuring high-titer, long-lasting memory antibody and T-cell immune responses.

Antigen Protection and Controlled Release via Delivery Systems

Easily degraded antigens (e.g., mRNA, peptides) have poor in vivo stability. We use delivery systems like liposomes and nanoparticles to provide physical protection and achieve sustained or controlled release of the antigen, extending the antigen presentation time and optimizing the immune effect.

Targeting APCs and Precise Immune Type Induction

Lack of effective delivery carriers makes it difficult for antigens to target Antigen-Presenting Cells (APCs). We provide custom delivery systems like ISCOMs, combined with adjuvants, to precisely guide the immune system to induce the required Th1/CTL or Th2 immune response for optimal therapeutic effect.

Core Platforms and Advanced Technologies

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SuperStable™ Thermostability Technology

Proprietary technology used to develop vaccine formulations that maintain high activity at room temperature, greatly reducing cold chain transportation costs.

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Custom Nanoparticle Systems

Constructing nanoparticles using polymer, protein, or nucleic acid carriers to achieve precise cellular targeting and controlled release.

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ISCOMs Delivery Platform

Immune Stimulating Complexes (ISCOMs) technology, capable of effectively inducing strong Cytotoxic T Lymphocyte (CTL) responses.

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High-Throughput Excipient Screening

Automated system for rapidly evaluating thousands of excipient combinations to quickly determine the optimal stabilizer and buffer system.

Standard Workflow for Vaccine Formulation Development

Project Evaluation and Antigen Characterization

  • In-depth analysis of the client's antigen type, structure, purity, and expected immune response type (Th1/Th2).

Excipient and Adjuvant Pre-screening

  • High-throughput screening of suitable excipients (stabilizers, buffers) and delivery system/adjuvant combinations based on antigen properties.

Candidate Formulation Optimization and Preparation Development

  • Determine liquid or lyophilization scheme and fine-tune formulation component ratios and process parameters using DOE (Design of Experiments).

Stability and Immunogenicity Testing

  • Conduct accelerated and long-term stability studies, as well as in vitro/in vivo immunogenicity assessments, to confirm the optimal pre-clinical formulation.

Process Transfer and GMP Scale-Up Support

  • Provide detailed process documentation and technical support to assist clients in a smooth transition to GMP manufacturing.

Core Advantages of Creative Biolabs

Extensive Adjuvant and Delivery System Library

Possessing industry-leading commercial and custom adjuvant/delivery systems for highly matched immune response design.

Expertise in Nucleic Acid Vaccines

Deep experience with nucleic acid delivery systems like LNP, providing translational support from lab to clinic.

SuperStable™ Stability Technology

Exclusive thermal stability technology significantly increases the shelf life of vaccines under non-cold-chain conditions.

Accelerated Project Timeline

Efficient screening processes and integrated platforms substantially shorten the time from formulation development to pre-clinical evaluation.

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Case Study

Norovirus Pd-FlaB Vaccine Adjuvant

Background

A study aimed to enhance norovirus (NoV) Pd vaccine's immune responses using FlaB (Vibrio vulnificus flagellin, a TLR5 agonist) as a mucosal adjuvant, given NoV's role in global gastroenteritis and Pd vaccine's weak mucosal immunity alone.

Solution

BALB/c and TLR5⁻/⁻ mice were immunized intranasally/sublingually with Pd alone, Pd+FlaB, FlaB, or PBS; some got subcutaneous Pd+FlaB, Pd+alum, or Pd+CFA. Immunity was assessed via ELISA (antibodies) and FACS (IFNγ⁺ T cells); adjuvants were compared.

Result

FlaB boosted Pd-specific IgG/IgA (serum/feces) TLR5-dependently, shifted Pd's Th2 response to mixed Th1/Th2 (higher IgG2a). It induced robust CD4⁺/CD8⁺ IFNγ⁺ T cells (spleen/MLNs) vs Pd alone, and outperformed alum/CFA in fecal IgA, proving it a potent NoV vaccine adjuvant.

A slide presenting a comparison of various vaccine adjuvants in terms of antibody induction.
Comparison of Various Vaccine Adjuvants for Antibody Induction.
Verma, Vivek, et al. "Norovirus (NoV) specific protective immune responses induced by recombinant P dimer vaccine are enhanced by the mucosal adjuvant FlaB." Journal of translational medicine 14.1 (2016): 135. Distributed under Open Access license CC BY 4.0, without modification. https://doi.org/10.1186/s12967-016-0899-4

Customer Reviews

"Our subunit vaccine required a novel adjuvant capable of precisely guiding a Th1 response. Creative Biolabs' adjuvant lab utilized high-throughput screening and PRR ligand scanning to quickly identify and optimize the best adjuvant combination for us. The immunogenicity data was much better than we anticipated, significantly accelerating our preclinical validation."

— Dr. Schmidt,

CEO, BioPharma Innovations

"We needed an adjuvant that could induce a highly effective CTL response. Creative Biolabs not only provided several customized PRR ligands but also optimized the binding efficiency of our antigen with ISCOMs. Preclinical data showed a marked improvement in immune efficacy."

— Dr. Johnson,

Project Lead, Global Pharma Co.

"The delivery system was critical for our viral vector vaccine project. Creative Biolabs' nanoparticle development service was highly professional, meeting our stringent requirements for targeting, from particle size control to surface modification."

— Mr. Müller,

CEO, NextGen Vaccines

Frequently Asked Questions

How does Creative Biolabs' formulation development address the stability challenges of RNA vaccines?

We focus on the precise optimization of Lipid Nanoparticles (LNP), including the selection of cationic lipids, adjustment of N/P ratios, and the use of cryoprotectants. This ensures high encapsulation efficiency of RNA within the LNP and stable LNP particle size and PDI under ultra-low or even refrigerated conditions.

What is SuperStable™ Thermostability Technology, and what temperature can it stabilize vaccines to?

SuperStable™ is a proprietary stabilization technology that primarily increases the glass transition temperature (Tg') of the vaccine through optimized excipient combinations and formulation processes (such as lyophilization). The goal is to develop formulations that can be stored long-term at 2-8°C or even room temperature (e.g., 25°C), significantly reducing reliance on the traditional cold chain.

How do I select the best adjuvant for my vaccine? Do you have a recommended adjuvant screening process?

Adjuvant selection depends on the antigen type, desired immune response (e.g., Th1, Th2, CTL), and target species. We offer multi-stage screening: starting with prediction based on antigen characteristics and PRR ligand scanning, followed by in vitro cellular models to assess immune pathway activation, and finally, in vivo immunogenicity validation in animal models to ensure the optimal adjuvant match for your antigen.

Does your delivery system optimization service include targeted delivery design?

Yes. Our nanoparticle and liposome delivery systems can be surface-functionalized (e.g., PEGylation, ligand conjugation) to achieve active or passive targeting of specific cell types (such as Dendritic Cells/APCs), thereby maximizing immunogenicity and delivery efficiency.

If my antigen is a small molecule or peptide, what differences are there in the formulation development?

For small molecules or peptides, the key lies in covalent conjugation (Hapten Conjugate) and the delivery system. We typically recommend using potent adjuvants (such as oil emulsions, adjuvant emulsions) and controlled-release carriers (such as microspheres or nanoparticles) to enhance immunogenicity and prolong antigen exposure time, effectively breaking immune tolerance.

Seamless Formulation Optimization

Don't let suboptimal formulation risk the future of your vaccine candidate. Contact us today to receive professional support and begin the critical optimization of your vaccine candidate's formulation!

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All of our products can only be used for research purposes. These vaccine ingredients CANNOT be used directly on humans or animals.

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