Vaccine manufacturing: Introduction to the process from development to large-scale production


Michael Eder

December 6, 2023

Table of contents


Vaccine manufacturing is a complex journey, merging scientific breakthroughs with global necessity. From the identification of antigens to large-scale production and the use of cutting-edge solutions, this journey reflects the continuous pursuit of creating effective vaccines for a healthier world.

Vaccines rank among the most cost-effective health interventions against pathogens and infectious diseases, annually saving millions of lives. However, growing global demand presents significant challenges for vaccine manufacturers. As the array of new vaccine types and manufacturing methods expands, the establishment of robust processes that could enhance overall efficacy, safety, and cost-effectiveness is hindered.

Efficient production, marked by flexibility and easy scalability, becomes increasingly crucial. In this article, we will give an introduction to vaccine manufacturing, the stages from development to large-scale production, explore challenges faced by manufacturers, and examine potential solutions and future prospects.

What is vaccine manufacturing?

Vaccine manufacturing is the complex and highly regulated process of producing vaccines, which are biological products designed to stimulate the immune system and provide protection against specific diseases. Vaccine development involves several stages, including vaccine research and development, production of raw materials, formulation, and quality control.

Read more: What is meant by vaccine production? | Steps in vaccine manufacturing

Vaccine development

Vaccine development begins at a small-volume stage – with the identification of antigens, where scientists select the key components that will trigger an immune response. The subsequent stage involves pre-clinical research, where the chosen antigens undergo extensive testing to ensure safety and efficacy.

Clinical trials assess vaccine performance in humans, focusing on immune response and vaccine safety. Regulatory bodies such as the Food and Drug Association (FDA), the European Medicines Agency (EMA) with its Committee for Medicinal Products for Human Use (CHMP), and World Health Organization (WHO) closely scrutinize these trials before granting approval, emphasizing the stringent processes in place to guarantee the production of high-quality vaccines.

Collaborations and partnerships between developers, research institutions, and 
regulatory authorities streamline the development pipeline. These alliances enhance efficiency and uphold global regulatory standards, contributing to collective efforts in achieving immunization goals.

The overarching goal is to address the urgent health needs. A prominent example was the development of COVID-19 vaccines in the fight against infectious diseases. These groundbreaking efforts showcase the intersection of scientific innovation, regulatory compliance, and global collaboration in the pursuit of creating effective vaccines that can withstand the demands of public health emergencies.1 

developing vaccines

Vaccine production

Vaccine production commences with the implementation of various manufacturing techniques, including cell culture, recombinant methods, viral vectors, and RNA-based approaches. The need for respective techniques depends on the vaccine type that is to be produced: The more complex the product, the more elaborate are the processes involved.2

This distinction becomes important when deciding whether to establish a production line for small-molecule or large-molecule vaccines, the latter of which require far more precise solutions, e.g. in cold chain management, due to their increased sensibility.2 

Manufacturing processes involved

The heart of vaccine production lies in diverse manufacturing techniques and processes, each playing a crucial role.

  • Cell culture methods involve cultivating cells to generate the necessary components for the vaccine.
  • Recombinant techniques utilize genetic engineering to produce specific proteins, contributing to the vaccine's effectiveness.
  • Viral vector methods and RNA-based approaches harness cutting-edge technologies to create vaccines with unique mechanisms of action.

Large-scale production

Moving beyond the confines of the laboratory, large-scale production marks a significant phase in vaccine manufacturing. Scaling up vaccine production and increasing manufacturing capacity to meet global demand requires intense planning and execution.

This phase ensures that the developed vaccines transition seamlessly from small-scale prototypes to mass-produced, high-quality immunization solutions.

The confluence of the different manufacturing techniques enables the creation of diverse vaccines that cater to various diseases and health challenges. The commitment to large-scale production reflects the collective dedication to making vaccines widely accessible for the betterment of global public health.

eBook: Filling Gaps in Managing Large Volumes of Biologics

Aseptic aliquotation and cryopreservation of drug substances are crucial process steps in bioprocessing. Even though they’re not in the spotlight of biomanufacturing. In drug development and drug delivery, biologics must be transferred at numerous occasions. Along the journey of monoclonal antibodies, vaccines and more, the drug substance passes lots of process steps where liquid transfer is required. This is relevant for the transitions between upstream processing, downstream processing and fill & finish, but also within these manufacturing milestones. The market of fluid & cold chain management has great growth potential and is on its way to professionalization and industrialization. To meet the challenges of manufacturing drug substances, Single Use Support helps manufacturers and CDMOs to advance their fluid & cold chain management process to achieve a secure and efficient process for liquids on the basis of single-use bags.
Large-scale vaccine production

Vaccine manufacturing companies

Vaccine manufacturing companies, including prominent players like Pfizer, Moderna, and AstraZeneca, alongside innovative biopharmaceutical firms such as Novavax, have assumed a crucial role in global public health.

Many of these manufacturers gained prominence, experiencing significant turnovers, particularly due to their contributions during the COVID-19 pandemic. Leveraging advanced technologies and collaborating extensively, these companies drive the development, production, and distribution of vaccines.3

Top 10 vaccine manufacturing companies by turnover 2021:

  • Pfizer
  • BioNTech
  • Sinovac
  • Moderna
  • Merck
  • GSK
  • Sanofi 
  • Zhifei
  • AstraZeneca
  • Johnson & Johnson

Source: 3 

Vaccine platforms

Just as there are multiple pathogens, each demanding a tailored approach, diverse vaccine technologies come into play for effective immunization. Depending on the targeted pathogen—be it a bacteria or virus—various vaccine platforms are harnessed to stimulate a potent immune response.

From traditional methods like live attenuated and inactivated vaccines to cutting-edge advancements like mRNA vaccines, the arsenal of vaccine platforms continues to expand, and can be divided into small molecule vaccines and the more complex and sensitive large molecule vaccines, requiring more elaborate cold chain management:

Small molecule vaccine technology platforms:

  • Live Attenuated Vaccines: Utilizing weakened forms of the pathogen to induce a robust immune response.
  • Inactivated Vaccines: Employing killed pathogens to stimulate an immune response without causing illness.
  • Toxoid Vaccines: Using inactivated toxins to generate an immune response, particularly effective against bacterial diseases.

Large molecule vaccine technology platforms:

  • Subunit Vaccines: Focusing on specific components of the pathogen to elicit a targeted immune response.
  • mRNA Vaccines: Leveraging genetic material to instruct cells to produce antigens, prompting an adaptive immune response.
  • Virus-Like Particle Based Vaccines: Mimicking the structure of viruses without the genetic material, inducing an immune response.
  • Viral Vector Vaccines: Harnessing other viruses as vectors to deliver genetic material, stimulating an immune response against the target pathogen.

Sources: 4 5 

History of vaccine manufacturing

The history of vaccine manufacturing reflects a journey from ancient variolation practices to modern breakthroughs. In the 19th century, Edward Jenner's pioneering smallpox vaccine marked a turning point, laying the foundation for systematic vaccine development. Louis Pasteur extended this paradigm with the first rabies vaccine in 1885.

The 20th century witnessed mass vaccine production, enabling global immunization efforts. A significant triumph occurred in 1980 with the eradication of smallpox, showcasing the profound impact of global vaccine supply on public health.

The 1980s brought forth recombinant DNA technology, allowing precise manipulation of antigens. In the 21st century, mRNA vaccines emerged as a game-changer, exemplified by their response to the COVID-19 pandemic.

In this historical journey is the collaborative effort to combat specific diseases such as polio, addressing challenges faced by diverse populations, including those in African countries and China. The continuous evolution, from traditional vaccines to innovative solutions like the influenza vaccine, demonstrates the resilience and adaptability of vaccine manufacturing in safeguarding global health and reducing hospitalization rates.

Read more: How were vaccines developed in the past? | Benefits of vaccine production

Source: 6 

Challenges in vaccine development and manufacturing

A considerable challenge in vaccine manufacturing comes with the adequate handling of different substances. The individual components need to be cultivated, stored and processed with high accuracy and under sterile conditions in order to provide patients with safe and effective vaccine products, which have to be dealt with equally carefully.

Another critical factor in vaccine development and manufacturing are the associated costs, spanning from research and development in laboratories to large scale manufacturing and subsequent distribution. Balancing the financial aspects while maintaining affordable vaccine accessibility poses a continuous challenge.7 


In order to limit both costs and time expenses involved in vaccine development and manufacturing, process efficiency is key. Streamlining production processes, minimizing wastage, and optimizing resource utilization contribute to addressing this challenge. Additionally, efforts have to be taken to enhance product viability and avoid product loss, as this can be bound to delays and considerable costs. However, enhancing efficiency not only impacts the cost-effectiveness of vaccine manufacturing but also ensures a more sustainable and scalable approach.

Cold Chain Challenges

From the initial stages of development in laboratories to the final distribution, maintaining an unbroken cold chain is crucial. Cold chain challenges encompass the need for consistent temperature control, especially for vaccines that are sensitive to temperature variations, such as mRNA vaccines Maintaining product viability is of utmost importance and, especially when dealing with large molecules, demands dedicated manufacturing solutions.

The transition from research and development settings to large-scale manufacturing facilities and eventual distribution to diverse geographical locations introduces complexities in sustaining the required cold chain conditions.

Innovation in cold chain solutions, such as advanced plate freezing technologies, safe and flexible ultra-cold storage solutions and temperature-monitoring systems, becomes imperative. As an expert in the field of fluid management Single Use Support is supplying vaccine manufacturers from laboratory heads to process managers with solutions for a seamless cold chain management.

cGMP regulations in vaccine production

Good Manufacturing Practice (GMP) and Current Good Manufacturing Practice (cGMP) regulations serve as a cornerstone to ensure the safety, quality, and consistency of vaccine manufacturing processes. These regulatory requirements, set by the FDA, establish a comprehensive framework that vaccine manufacturers must adhere to during every stage of production.

The cGMP regulations for vaccine manufacturing encompass various facets, including facility design, equipment validation, personnel training, and documentation practices. These guidelines are designed to minimize the risks of contamination or quality deviations during vaccine production, ensuring that each batch meets the required specifications and is safe for public consumption.8 

Regulations in vaccine manufacturing

Solutions for efficient vaccine manufacturing

Enhancing efficiency in vaccine manufacturing is a critical goal that involves addressing challenges in various stages of the production and distribution process. Several innovative solutions contribute to making the fluid management process of vaccines more efficient whilst ensuring their quality.

Cold chain solutions

Maintaining the integrity of vaccines during storage and transportation is an important aspect of the cold chain. Implementing advanced cold chain solutions for vaccine development involves employing cutting-edge freeze-thaw technologies, ultra low temperature storage and temperature-monitoring systems. These solutions based on single-use technologies play a crucial role in preventing inadequate cooling that could compromise the efficacy of vaccines, especially those sensitive to environmental conditions.

Single Use Support takes the individual fluid management spectrum in vaccine manufacturing into consideration to provide tailored end-to-end solutions ranging from automated filling into single-use bags to freezing with plate freezers. Notably, the plate-based freezing technology employed by Single Use Support is a flagship solution in terms of the quality of the freezing and thawing process. Covered in single-use shells, the single-use bioprocess containers undergo rapid and controlled rate freezing. The controlled freezing rates based on product characteristics prevents unwanted effects that potentially reduces product viability, such as cryoconcentration or crystallization.

Whitepaper: How Controlled & Scalable Freezing Becomes Reality

Scalability around freezing means the ability to guarantee constant freezing kinetics on proteins (biopharmaceutical molecules) in all scales, filling volumes and loading scenarios. This guide covers how to achieve scalable freezing & thawing of biopharmaceuticals by showing What is scalability? Setup for controlled icefront growth speed Scalability results Outcomes

Ultra low temperature storage of vaccines

To further enhance the preservation of frozen substances, Single Use Support’s solution for ultra low temperature storage of vaccines, RoSS.FRDG, comes into play. This solution allows precise temperature control during storage and transportation.

Such modular innovative storage solutions have emerged as a game-changer in the production and supply chain of vaccines as well as raw materials for vaccine production. Vaccines, especially those utilizing advanced technologies like mRNA, often require storage at extremely low temperatures. Ultra-low temperature storage solutions provide a reliable and efficient means of preserving the potency of these vaccines, ensuring they remain viable during production, distribution and administration, without the need to build large walk-in freezers.

Vaccine manufacturing: Introduction to the process from development to large-scale production

Single-use technologies in vaccine manufacturing

The adoption of single-use technologies in vaccine manufacturing offers notable advantages. This approach replaces traditional stainless-steel equipment with disposable components, streamlining the manufacturing process and reducing the risk of cross-contamination.

Single-use technologies enhance flexibility, scalability, and efficiency in vaccine production, allowing for more rapid production scale-up and responsiveness to evolving demands. Additionally, they allow manufacturers to maintain crucial parameters along different scales in production, e.g. the freezing curve that had been established at lab scale and has to be mimicked at larger scales.

Furthermore, in environments where production lines change regularly, or multiple production processes run in parallel, single-use systems provide a versatile platform that can be efficiently adopted to varying requirements.

These solutions collectively contribute to efficient vaccine manufacturing by addressing logistical challenges, optimizing storage conditions, and streamlining production processes. Operating on single-use technology, all the fluid management solutions from Single Use Support facilitate flexible and scalable handling of vaccines—from laboratory development to large-scale production.

The landscape of vaccine production is continually evolving, with emerging technologies driving innovation. Novel vaccine manufacturing methods such as recombinant DNA technology, mRNA vaccines, and viral vector methods are at the forefront. These technologies open new possibilities for creating vaccines with enhanced efficacy and less side effects.

The future of vaccine manufacturing involves envisioning a landscape characterized by increased collaboration, streamlined processes, and broader accessibility. A shift towards increased utilization of single-use technologies brings notable advantages, encompassing manufacturing efficiency, contamination safety, and enhanced scalability and flexibility based on demand.

Future trends in vaccine development suggest a continued focus on personalized therapeutics, tailoring immunization strategies to individual needs. Additionally, advancements in data analytics, artificial intelligence and Pharma 4.0 are likely to play a pivotal role in optimizing production processes and accelerating vaccine development.

In conclusion, the dynamic and innovative field of vaccine manufacturing remains a critical force in safeguarding global health. From historical milestones to cutting-edge technologies, the journey of vaccines reflects humanity's ongoing commitment to preventing infectious diseases and ensuring a healthier future for all.

FAQs about vaccine manufacturing

What are regulatory bodies in vaccine development and production?

Regulatory bodies overseeing vaccine development and production include the FDA (Food and Drug Administration) in the U.S. and the European Medicines Agency (EMA) overseeing and regulating vaccine development and production, particularly within the European Union. The CDC (Centers for Disease Control and Prevention) is another key regulatory body in the rise of endemic and pandemic events. The These organizations play a crucial role in ensuring the safety, efficacy, and compliance of vaccines within the healthcare system.

How are vaccines produced?

Vaccines are produced through a complex process involving several key steps. First, antigens or components of the pathogen are identified. These antigens can be cultivated in bioreactors using specific cell lines. Subsequently, the purified antigens undergo formulation, often with adjuvants to enhance the immune response. The purification process ensures the removal of impurities, resulting in a high-quality vaccine that stimulates the production of antibodies, crucial for effective immunization.

What is the process of creating a vaccine?

Creating a vaccine involves a defined process that typically includes identifying antigens, conducting pre-clinical research, performing clinical trials, and obtaining regulatory approval. This process aims to ensure the safety, efficacy, and immunogenicity of the vaccine before it is manufactured and distributed for public use.

What is the adverse reporting system?

In pharmacovigilance, the adverse reporting system is a crucial mechanism for individuals, healthcare professionals, or manufacturers to report any adverse events or side effects associated with vaccines or medications. It plays a vital role in monitoring and ensuring the safety and immunogenicity of vaccines, as well as other biopharmaceutical products. By collecting and analyzing data on potential risks, this system contributes to the continuous improvement of public health and the overall safety profile of these medical interventions.

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7 trends in global vaccine development 2024

Vaccine production is characterized by ongoing changes, adaptations and improvements. In this article, we will take a look at 7 trends in global vaccine development.

What are novel methods in vaccine manufacturing?

What are novel methods in vaccine manufacturing?

Vaccine manufacturing is an ever-evolving area. In this Article, we will cover some novel approaches that biopharma increasingly relies on.

Steps in vaccine manufacturing & what support is needed?

Steps in vaccine manufacturing & what support is needed?

Vaccine manufacturing involves a set of specific manufacturing steps, each having to be carried out with the highest diligence – we will explore them in this article.

13 vaccine manufacturing companies you need to know

13 vaccine manufacturing companies you need to know

The vaccine market is shaped by numerous companies, from smaller newcomers to international concerns. In this article, we will uncover 13 vaccine manufacturing companies you ought to know.


Challenges in vaccine development & manufacturing

Vaccine development and manufacturing are a challenging business and in order to be efficient and successful manufacturers will have to adopt advanced technologies. The obstacles are manifold and the fragility of supply chains or requirements in cold chain management are just two of the challenges in vaccine manufacturing.

Meeting cGMP standards for vaccine manufacturing

Meeting cGMP standards for vaccine manufacturing

cGMP plays a fundamental role in several stages of vaccine manufacturing. In this article, we will examine this role in more detail, including its manifold implications for vaccine manufacturers.

  1. How Vaccines are Developed and Approved for Use,, Published 2023
  2. Vaccine manufacturing,, Published 2013-10-18
  3. The top 10 vaccine companies worldwide,, Published 2022
  4. Vaccine platforms,, Published 2023
  5. Understanding Six Types of Vaccine Technologies,, Published
  6. A brief history of vaccines,, Published
  7. The complexity and cost of vaccine manufacturing – An overview,, Published 2017-06-22
  8. Current GMP standards for the production of vaccines and antibodies: An overview,, Published 2022-11-03

Michael Eder

Senior Marketing Manager

Michael Eder, MA, is Senior Marketing Manager at Single Use Support. He is expert in pharma and health communication with his 8+ years experience in pharma. After completing his master's degree in International Healthcare Management at MCI The Entrepreneurial school in Innsbruck, he has gained experience in the pharmaceutical field. Michael creates articles about Freeze Thaw applications and Platform solutions from Single Use Support and is the author of current news with Single Use Support worldwide. 

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