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Vaccine Process Development and GMP Manufacturing Solution

Creative Biolabs leverages six major expression systems and advanced technology platforms to provide an end-to-end one-stop CDMO solution, covering process development, scale-up, and final product manufacturing, ensuring your vaccine project achieves the highest quality, fastest speed, and maximum yield for commercial translation.

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Core Topic Description: Key Challenges We Solve for You

Vaccine R&D and large-scale manufacturing is a challenging and complex process that demands both profound scientific knowledge and precise management of the industrialization pathway. During this critical translation phase, our clients often face a series of bottlenecks that directly impact project speed, final product quality, and market entry efficiency. We summarize the key challenges clients mainly encounter:

Expression System Selection and Optimization Challenges

Faced with various vaccine types (viral vectors, protein subunits, etc.), how can one quickly determine and optimize the most suitable expression system to achieve maximum yield and activity?

Process Scale-Up and Repeatability Challenges

During the transition from lab-scale pilot runs to commercial large-scale manufacturing, how can process stability and scalability be ensured while maintaining high batch-to-batch product quality consistency?

Complexity of Quality Control and Analytical Method Validation

Establishing and validating a complete, sensitive analytical method system (including potency, purity, safety, and stability tests) to accurately assess and release vaccine batches is often time-consuming and technically demanding.

End-to-End Vaccine Process Development and GMP Manufacturing Solutions

Expression System Evaluation

We evaluate and optimize six major vaccine expression systems (bacterial, yeast, insect, mammalian, plant, and cell-free) to determine the most efficient, high-quality, and cost-effective production scheme for your antigen.

Small-Scale and Scale-Up Development

We begin with small-scale process optimization to lay a solid foundation for subsequent large-scale manufacturing, gradually transitioning to industrial-scale process verification and optimization to ensure a balance between production efficiency and cost-effectiveness.

Vaccine Large-Scale Production

Our large-scale vaccine manufacturing services focus on the high-quality production of Drug Substance and Drug Product, utilizing classic egg-based vaccine production and modern cell-based vaccine production techniques, ensuring product stability and high purity.

Serum-Free Suspension Culture

We develop and optimize serum-free, animal component-free suspension media and processes to increase cell growth density and target product yield, while meeting the highest safety and quality requirements.

High-Quality Antigen Production

Creative Biolabs delivers customized high-purity core antigen manufacturing services for animal and human vaccines, ensuring excellent activity and safety. Services cover expression, purification, and high-quality preparation of viral antigens (e.g., PRV, PCV2, AI, NDV, PPV, Rabies) and complex subunit vaccine antigens.

Core Technology Platforms

A slide introducing the High-Throughput Screening (HTS) Platform within the Vaccine GMP Manufacturing Solution.

High-Throughput Screening (HTS) Platform

Rapidly screens for the best expression vectors, cell lines, and media formulations.

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Automated Bioreactors

Provides precise control and scalability from 1L up to 2000L.

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Continuous Chromatography

Achieves high purity and high yield in downstream purification.

A slide presenting Mass Spectrometry and Advanced Characterization Analysis (LC-HRMS) for the Vaccine GMP Manufacturing Solution.

Mass Spectrometry and Advanced Characterization Analysis (LC-HRMS)

Provides deep analysis and characterization of Critical Quality Attributes (CQAs) of vaccine antigens.

Contact us for Detailed Service Items

Vaccine Process Development and Manufacturing Process

Project Initiation & Initial Development

  • Antigen design and expression system determination.
  • Cell line/strain construction and screening.
  • Small-scale feasibility study (Proof of Concept).

Upstream Process Development & Optimization

  • Media optimization, fermentation/culture condition (pH, DO, temperature) optimization.
  • Harvest process development for virus/VLP/recombinant proteins.

Downstream Process Development & Purification

  • Capture, intermediate purification, polishing, and viral inactivation/clearance process development.
  • Buffer screening and sterilizing filtration validation.

Formulation & Stability Study

  • Final product formulation screening, excipient optimization, and lyophilization process development (if applicable).
  • Determination of optimal storage conditions and preliminary stability data.

Scale-Up & Engineering Batch

  • Gradual scale-up from development scale to pilot scale.
  • Production of high-quality engineering batches to verify process repeatability.

Large-Scale High-Quality Production & Delivery

  • Manufacturing of production batches, providing complete quality control documentation. Strict Quality Control (QC) and Quality Assurance (QA) release to ensure high purity and stability of the product.
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Core Strengths of Creative Biolabs

Comprehensive Expression System Coverage

Proficiency in six major systems (bacterial, yeast, baculovirus, mammalian, plant, and cell-free), offering truly customized options for clients.

Top-Tier Quality Control System

Implements rigorous quality monitoring throughout the entire process, ensuring stable, reliable, and highly consistent batch-to-batch product delivery.

End-to-End One-Stop Service

Covers the entire process from early research, process development, to large-scale manufacturing, mitigating risks and delays associated with technology transfer.

Rich Animal Vaccine Experience

Deep technical expertise and successful case history in the production of various animal vaccine antigens, including swine fever, avian influenza, and rabies.

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Customer Reviews

"Creative Biolabs showed impressive professionalism in our PCV2 subunit vaccine project. They not only solved our purity bottleneck during scale-up but also delivered the high-quality batch product with extremely high purity, two months earlier than expected."

— L. Chen,

CEO of an Asia-Pacific Biotechnology Company

"Our recombinant protein antigen had a complex structure with extremely high demands for post-translational modification. Creative Biolabs' mammalian expression system optimization service successfully tripled the yield while maintaining the antigen's native activity, which was crucial for our subsequent preclinical trials."

— Dr. M. Schmidt,

Head of a European Innovative Vaccine R&D Team

"As a startup, we highly value cost control and technical support. The Creative Biolabs team not only provided cost-effective process development services but also offered detailed technical and quality management advice, making them our most reliable partner in the vaccine CDMO field."

— P. Singh,

Director of Operations at a North American Biopharma Company

Case Study

ZIKV-Neisseria meningitidis Outer Membrane Vesicle Vaccine Production

Background

A study aimed to develop a nanostructured ZIKV vaccine using N. meningitidis OMVs (safe, biocompatible) to address ZIKV's threat (congenital defects, Guillain-Barré syndrome) and lack of effective vaccines, leveraging OMVs' ability to carry viral epitopes.

Solution

OMVs were extracted from N. meningitidis via ultrafiltration. ZIKV (BeH823339 strain) replicated in C6/36 cells; OMVs fused with ZIKV via mechanical agitation. The vaccine was inactivated (56°C/1h) and lyophilized. Characterizations used Zetasizer, NTA, SEM/STEM, and HRMS; immunogenicity tested in Swiss mice (ELISA, qRT-PCR for neutralization).

Result

ZIKV-OMV had suitable size (230.25±20.85nm, NTA:253.5±5.0nm), low PDI, and stable charge. HRMS detected ZIKV lipid markers. Mice had anti-ZIKV IgG titres >1:160, Th1/Th2 responses (IL-2, IL-4, TGFβ), and serum neutralized ZIKV (reduced RNA copies). Mesoporous silica adjuvant added no benefit. The production is low-cost, scalable, and effective.

A slide displaying the protocol for ZIKV-OMV Vaccine Production.
Protocol for ZIKV-OMV Vaccine Production.
Martins, Paula, et al. "Outer membrane vesicles from Neisseria Meningitidis (Proteossome) used for nanostructured Zika virus vaccine production." Scientific reports 8.1 (2018): 8290. Distributed under Open Access license CC BY 4.0, without modification. https://doi.org/10.1038/s41598-018-26508-z

FAQs of Vaccine Process Development and Manufacturing Solution

What types of vaccine development does Creative Biolabs support?

We support a wide range of vaccine types, including but not limited to: recombinant protein subunit vaccines, virus-like particle (VLP) vaccines, inactivated/live attenuated viral vaccines, viral vector vaccines (such as adenovirus, lentivirus), and specific nucleic acid vaccine (mRNA/pDNA) related antigen production.

How do you maximize the yield and purity of my vaccine antigen?

We utilize a customized high-throughput screening platform to rapidly optimize expression vectors, media, and culture conditions, combined with advanced continuous chromatography technology, to boost yield at the source and achieve ultra-high purity downstream.

What is the approximate timeline for process development to large-scale manufacturing?

The timeline depends on the complexity and starting stage of the vaccine. Typically, a moderately complex project from expression system determination to the first large-scale batch takes approximately 6 to 9 months. We are committed to further shortening this time through fast-track and platform technologies.

How is batch-to-batch quality consistency ensured during process scale-up?

We systematically identify Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs). During scale-up, we use rigorous scale-up model verification and process validation to ensure that the quality of all batches remains within the predefined range.

How does Creative Biolabs help clients maximize cost-effectiveness?

We reduce raw material waste through early process optimization and utilize highly efficient continuous chromatography and serum-free suspension culture technologies to significantly increase recovery rate and batch yield, thereby reducing overall manufacturing costs without compromising quality.

High-Quality Antigen Production

Don't let unreliable antigen supply compromise your vaccine development timeline or results. Contact us today to receive professional support and secure the high-purity, scalable antigens your vaccine innovation journey demands!

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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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