5 Solutions for Overcoming Research Challenges in Vaccine Development

What are the main challenges in vaccine development?

The main challenges in vaccine development include identification and isolation of the pathogen or antigen that triggers a statistically significant immune response, formulating and testing its efficacy and safety in preclinical studies, conducting clinical trials, and ultimately scaling up to large-scale production.

Researchers must learn to navigate challenges in vaccine development, balancing safety, efficacy, speed, and cost while navigating scientific and regulatory challenges. Let’s explore the vaccine development process, highlight common research problems, and review five tested solutions to overcome them: optimizing antigen design, choosing the right expression system, streamlining purification workflows, addressing formulation stability, and leveraging scalable manufacturing platforms. With these strategies and the support of industry experts like those at Thermo Fisher Scientific, labs can accelerate vaccine discovery while maintaining quality and compliance.

Vaccine development process

The vaccine development process begins with identifying an antigen capable of triggering an immune response. The process typically follows several phases:

• Discovery & Preclinical Research – Identifying targets and testing safety in non-human models.
• Clinical Trials (Phases I–III) – Evaluating safety, dosage, and efficacy in humans.
• Regulatory Review & Approval – Ensuring compliance with safety and efficacy standards.
• Manufacturing & Distribution – Scaling up production for global access.

This process often takes years, though recent advances—such as mRNA vaccine platforms—have shown that timelines can be significantly shortened when bottlenecks are addressed effectively.

Common problems in vaccine research

Despite breakthroughs, researchers face several recurring challenges:

• Antigen design issues leading to weak immune responses
• Low yield in expression systems
• Complex purification processes that slow timelines
• Formulation instability during storage and transport
• Manufacturing scale-up bottlenecks that delay distribution

These obstacles highlight the need for optimized strategies at every step of the development pipeline.

Tested solutions for challenges in vaccine development

1. Optimize antigen design early in the process

Choosing the right antigen is critical. Using computational tools and structural biology insights, teams can predict epitopes more effectively. Early optimization reduces the risk of failed trials and speeds time-to-market.

2. Select the right expression system for your vaccine type

Different vaccine modalities—such as protein subunit, viral vector, or mRNA—require tailored expression systems. For instance, mammalian cell cultures may be an ideal choice for complex proteins, while microbial systems can provide faster, cost-effective yields. See magnetic beads for PCR & NGS library prep.

3. Streamline purification workflows

Purification can consume up to 80% of production time. Implementing high-throughput chromatography and integrated workflows help ensure consistent purity and reduces process bottlenecks. Alternatively, automated systems like KingFisher purification instruments combined with Dynabeads Streptavidin for IVT or Dynabeads Carboxylic Acid for RNA purification  can improve your workflow and help provide reproducible results.

4. Address formulation stability early

Formulation challenges can lead to loss of potency during storage or transport. Early stability testing, combined with excipient optimization, prevents costly delays and helps ensure vaccines remain effective throughout distribution.

5. Leverage scalable and flexible manufacturing platforms

Scalability is crucial when moving from lab to global production. Flexible bioprocessing platforms, modular facilities, and single-use technologies enable faster responses to outbreaks and support long-term vaccine availability. There are several manufacturing services at you disposal including  media manufacturing services, Single-use bioprocessing, and cGMP custom manufacturing.

Challenges in vaccine development

Even with these solutions, challenges remain:

• Regulatory requirements are strict and differ by region.
• Clinical trials are expensive and time-consuming.
• Cold-chain logistics complicate global distribution.

Collaboration across academia, industry, and government agencies is essential to address these systemic issues.

mRNA synthesis

One way researches can accelerate their mRNA vaccine development is through the use of Dynabeads Streptavidin for In Vitro Transcription. Streptavidin beads are used for mRNA synthesis by solid phase in vitro transcription (IVT), a workflow that can greatly accelerate the research and development of mRNA vaccines by using a biotinylated DNA template of choice, either amplified via PCR or as biotinylated plasmid, and immobilized to streptavidin beads (Figure 1). This immobilization process replaces purification process after PCR or plasmid digestion, as mixing with the streptavidin beads allows removal of all the previous reaction components.

After IVT, that DNA template stays immobilized on the streptavidin beads and as such is removed from the produced mRNA by simple magnetic separation. That immobilized template can be reused in the next IVT reaction at least six times, increasing the mRNA output per used template. Also, solid phase IVT simplifies consecutive purification process as DNase digestion is not needed, and the mRNA can be purified with Dynabeads Carboxylic Acid for RNA Purification via simple bind-wash-elute process (Figure 2).

Thermo Fisher Scientific – vaccine development

Thermo Fisher Scientific plays a key role in accelerating vaccine development. From antigen discovery tools to bioproduction platforms and purification solutions, Thermo Fisher offers scalable technologies that help researchers overcome critical bottlenecks. By combining scientific expertise with end-to-end solutions, the company empowers teams to move vaccines from concept to clinic faster and with greater confidence.

FAQ: Overcoming vaccine development challenges

Q: Why is vaccine development so complex?

Because it must balance safety, efficacy, scalability, and regulatory compliance, all while addressing biological variability.

Q: What’s the fastest-growing innovation in vaccine research?

mRNA-based vaccines, which allow for rapid antigen design and scalable production.

Q: How can companies reduce risk during early development?

By integrating antigen design optimization, robust stability studies, and flexible manufacturing early in the process.

Vaccine research and development tools and services

Target discovery

• KingFisher purification systems
• Collibri NGS library preparation kits for Illumina
• Biological safety cabinets
• ProcartaPlex Immunoassays

Candidate vaccine synthesis and functional analysis

• GeneArt Gene Synthesis and Protein Services
• Gibco Expi Transient Expression Systems
• CellInsight CX7 LZR Pro HCS Platform
• Invitrogen EVOS M7000 Imaging System

Production process development

• Media manufacturing services
• Single-use bioprocessing
• cGMP custom manufacturing
• TSX Series ultra-low freezers

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For Research Use Only. Not for use in diagnostic procedures.   

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