Vaccine Analytical Development & Qualification Solution

Creative Biolabs offers end-to-end CMC support from early method development through the preclinical stage. Our solutions encompass comprehensive in vitro assessment (identity, purity, potency, stability) and in vivo assessment (toxicology & PK/ADME), ensuring your vaccine project advances efficiently, meets the highest quality and robustness requirements, and lays a solid foundation for subsequent clinical applications.

Addressing Your Core Business Challenges

The reliability and robustness of analytical methods are critical factors determining the success of preclinical advancement in early vaccine development. We offer specialized solutions for the most common CMC challenges, ensuring your product quality and safety meet all early development requirements.

Analytical Method Robustness

We help clients establish a highly robust and reproducible analytical method validation data package, suitable for early product development and QC, ensuring data reliability and accelerating entry into preclinical studies.

Complex Quality Control

For novel vaccines (e.g., mRNA, viral vectors), we provide innovative and specific analytical methods to accurately measure complex structures, impurities, and trace potency, overcoming traditional analytical bottlenecks.

Stability and Release Criteria

We assist in formulating scientific stability testing protocols and rigorous batch release criteria. We offer accelerated, intermediate, and long-term stability studies to ensure product quality and shelf life.

Details of Our Vaccine Analysis Solution

In Vitro Assessment

Identity Assessment

Confirmation of vaccine structure, antigen specificity, protein/nucleic acid sequence, etc., using methods like peptide mapping, mass spectrometry, SEC-HPLC, and ELISA.

Purity Assessment

Detection of process impurities, host cell proteins (HCP), residual nucleic acids, aggregates, and fragmentation. Using methods like SDS-PAGE, Western Blot, CE, and HPLC.

Microbial Assessment

Sterility testing, mycoplasma detection, endotoxin testing, and viral contamination screening to ensure product biosafety.

Potency Assessment

Measurement of the vaccine's ability to activate the immune system. Includes cell-based assays (e.g., VNT), ELISA binding tests, and neutralizing antibody titer analysis.

Stability Assessment

Monitoring of quality attributes under long-term, accelerated, and stress conditions (light, temperature, humidity) to determine storage conditions and shelf life.

In Vivo Assessment

Toxicology & Safety Assessment

Single-dose/repeat-dose toxicity studies, local reactivity studies, hypersensitivity, and systemic reaction assessments, adhering to high-standard laboratory practices.

In Vivo ADME & PK Study

Analysis of the absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetics (PK) of the vaccine or its vector for dose design.

Reproductive Toxicology Study

Assessment of the vaccine's potential impact on fertility and embryonic development, especially for vaccines intended for specific populations.

Advanced Platforms and Technical Support

High-Resolution Mass Spectrometry Platform

Used for precise determination of protein sequence, post-translational modifications, and impurity structure identification, providing high-accuracy data for vaccine purity and identity.

HPLC/UPLC/SEC-HPLC

Used for efficient separation and quantification of vaccine components, purity, and aggregate analysis, serving as a core tool for routine QC and stability studies.

Cell and Virus Neutralization Tests

Used to assess the vaccine's ability to induce neutralizing antibodies, serving as the most critical and relevant *in vitro* method for quantitative Potency confirmation.

Automated Data Analysis System

Ensures real-time processing, accuracy, and traceability of large-scale experimental data, and adheres to a strict Quality Management System to accelerate report generation and archiving.

Standard Workflow for Vaccine Analytical Development and Qualification

Method Development & Optimization

Developing new methods with high specificity and sensitivity based on vaccine characteristics.

Method Validation & Qualification

Strictly following internal quality standards to validate key parameters like specificity, accuracy, and precision.

Sample Testing & Quality Control

Routine testing of stability samples, batch release samples, and in-process control samples.

High-Quality Reporting & Deliverables

Generating high-quality, traceable experimental reports to efficiently support clients in advancing key preclinical milestones.

Partner with Creative Biolabs Now!

Creative Biolabs Core Advantages

High-Standard Quality System

Our team adheres to strict internal quality standards and a rigorous Quality Management System, ensuring the scientific integrity and reliability of all experimental methods and data, providing a solid basis for clients' early decision-making.

One-Stop In Vitro & In Vivo Integration

Exclusively offering seamless integration of In Vitro analysis and In Vivo PK/Toxicology assessment services, greatly simplifying the supply chain and accelerating project timelines.

High Throughput and Rapid Delivery

Utilizing automated platforms and optimized SOPs to ensure high efficiency in method development and qualification, shortening the client's vaccine R&D cycle.

Focus on Novel Vaccine Technologies

Possessing leading analytical technologies on innovative platforms such as mRNA, viral vectors, and peptide vaccines, offering customized solutions.

A slide highlighting the Core Advantages of Creative Biolabs regarding the Vaccine Analytical Development & Qualification Solution.

Case Study

Mannosylated Lipid Nanoparticles for RSV SAM RNA Vaccine Analytical Development Background

Background

A study aimed to develop and analyze mannosylated lipid nanoparticles (MLNPs) as delivery systems for a self-amplifying RNA (SAM) vaccine encoding RSV F protein, given LNPs' role in protecting RNA and MLNs' potential to target APCs via mannose receptors.

Solution

MLNs with mono- (M1) to tetrasaccharide (M4) mannans were formulated (2%/0.3% PEG). Analyses included particle size/PDI (Zetasizer), RNA encapsulation (Ribogreen), antigen integrity (agarose gel), mannan exposure (ConA assay), and in vivo immunogenicity (ELISA for IgG/IgG1/IgG2a in BALB/c mice via IM/ID routes).

Result

MLNs had acceptable size (<200nm, PDI<0.2), >70% RNA encapsulation, and intact SAM. ConA binding confirmed mannan exposure (enhanced at 0.3% PEG). M2 (disaccharide) MLNs boosted IgG/IgG2a vs LNPs; 0.3% PEG improved immunogenicity. IM/ID routes worked, supporting MLN use for RNA vaccine development.

A slide displaying a schematic of LNP formation and the synthesis of mannan-cholesterol amine conjugates (M1-M4).

Schematic of LNP formation and synthesis of mannan-cholesterol amine conjugates (M1-M4).
Goswami, Roshan, et al. "Conjugation of mannans to enhance the potency of liposome nanoparticles for the delivery of RNA vaccines." Pharmaceutics 13.2 (2021): 240. Distributed under Open Access license CC BY 4.0, without modification. https://doi.org/10.3390/pharmaceutics13020240

Client Trust

"Creative Biolabs' expert team provided outstanding support in validating our in vitro potency assay. The detail and rigor of their reports were crucial for moving our preclinical studies forward."

- Dr. Thompson,

Biotech CMC Director

"Their one-stop service, particularly the integration of toxicology studies, saved us significant time and management overhead. Professional and highly efficient!"

- Ms. Rodriguez,

Pharma Project Manager

"Their HRMS platform delivered unprecedented sensitivity and accuracy for our mRNA vaccine impurity analysis, solving a challenge our internal team could not resolve."

- Prof. Schmidt,

Academic Research Principal Investigator

Frequently Asked Questions

How do you ensure the high robustness of analytical methods?

All analytical method development and validation strictly follows our highest internal quality and robustness standards, ensuring all data is reliable and reproducible for preclinical trials and early CMC stages.

Do you offer customized services for novel vaccines?

Yes. We have extensive experience and specialized platforms for nucleic acid vaccines (e.g., measuring mRNA integrity, LNP encapsulation rate) and viral vector vaccines (e.g., VNT potency assay, full/empty capsid ratio analysis), offering fully customized solutions.

If I only need one specific in vivo toxicology study, can I commission it separately?

Absolutely. Our service model is highly flexible. Clients can select individual in vitro or in vivo assessment items based on their specific needs, or choose the full integrated solution. All in vivo studies adhere to high-standard laboratory practices.

What is the typical timeframe for method validation?

Standard method validation (e.g., HPLC purity, ELISA identity) is typically completed within 6-8 weeks, but complex biological potency assays may require 10-12 weeks. The exact timeline is determined by the method complexity and the status of client-provided samples.

Regarding in vitro potency confirmation, what are your commonly used techniques and methods?

We primarily rely on cell-based assays (e.g., Virus Neutralization Test VNT, Plaque Reduction Neutralization Test PRNT), receptor-binding ELISAs, SPR, or BLI (Bio-Layer Interferometry) technology. We customize the most relevant and sensitive biological activity assay method based on the vaccine's mechanism of action and antigen characteristics.

Analytical Excellence for Vaccine Success

Don't let inadequate analytical data stall your regulatory filings or clinical trials. Partner with the analytical experts at Creative Biolabs to receive professional support and secure the robust analytical solutions needed for successful vaccine qualification!

Inquire Now

Featured Resources

Reference image of vaccine-resources-1, containing materials relevant to vaccine research and development.

Download Resources

Visual of vaccine-literature-1, representing academic or technical literature focused on vaccine studies.

Vaccine Analytical Development and Qualification Solution