November 30, 2023
Steps in vaccine manufacturing & what support is needed?
Behind vaccines' potency lies a complex manufacturing process, supported by crucial elements that ensure a safe and efficient production as well as a widespread distribution.
On average, it takes 10 to 15 years to bring a vaccine from concept to market. However, the urgent demands caused by the COVID-19 pandemic catalyzed advancements, compressing the traditional timeline and showcasing the remarkable capabilities of the scientific community.
In this article, we discuss the various steps of vaccine manufacturing and shed light on the support needed in manufacturing to bring these biologics to the global stage.
Research and development
The actual production process is preceded by a research and development phase in laboratory settings. In antibody discovery, scientists work on identifying substances that can effectively stimulate an immune response. Efficacy testing follows, involving rigorous experiments to ensure the vaccine's ability without compromising safety.
Supporting vaccine development in laboratories
Efficient vaccine development requires state-of-the-art facilities, cutting-edge equipment, and adaptable solutions that adhere to regulatory standards.
The utilization of single-use technology and innovative fluid management solutions represents a leap forward in laboratory efficiency. By minimizing manual handling, automated and closed fluid management solutions reduce the potential for human errors if not eliminate product loss of high-valuable liquids. Automated processes help a laboratory head and lab technician further elevate efficiency. It also contributes to streamlining operational costs.
Single Use Support is committed to extend to the specific needs of small-scale vaccine development. The global process solution provider’s solutions adapt to filling and freezing requirements for vaccine development.
Ensuring the controlled freezing of lipid nanoparticles or plasmid DNA is essential in vaccine production to guarantee efficacy. Whether plate-based freezing to -80°C or liquid-nitrogen-based controlled freezing to -170°C, a controlled-rate freezing approach has proved to be a best practice for highest product viability.
These advancements in the stages of vaccine development lead to higher quality at lower development costs and also facilitate the transition to large-scale production.
Steps in vaccine manufacturing
1. Cell culture and harvesting
Cell culture and harvesting serves as a crucial bridge between discovery and large-scale production. Cell culture techniques contribute to the optimization of cell growth, enabling the efficient generation of high-quality antigens essential for the development of advanced immunization solutions.
Harvesting, a precision-oriented process, separates cells and extracts antigens with innovations minimizing damage. The synergy of cultivation and harvesting drives vaccine development toward the creation of safe, effective, and globally accessible immunization solutions.
2. Purification process
Purification involves the removal of impurities from the harvested material, ensuring the final product meets stringent safety and efficacy standards. Cutting-edge purification technologies, such as chromatography and filtration, are applied to separate the valuable antigens from unwanted elements.
3. Formulation and filling
The formulation process involves crafting a precise mixture that ensures stability, efficacy, and the preservation of the vaccine's therapeutic power. Formulation technologies, such as lyophilization, contribute to the longevity and stability of selected vaccines. Once formulated, the drug substance is precisely filled into small bioprocess containers, ensuring accurate dosages.
4. Quality control
The final stage of quality control ensures the alchemy of safety and potency is perfected. This stage subjects the vaccine to a battery of tests and inspections, guaranteeing it meets stringent regulatory standards. Every batch undergoes scrutiny for purity, potency, and consistency.
eBook on managing large volumes of biologics – download
Support in large-scale vaccine manufacturing
During the journey of vaccine manufacturing, the drug substance or raw materials navigate through multiple stages. The substances like LNPs or mRNA or even finished vaccines traverse various sites and cross international borders.
Therefore, manufacturing and upscaling vaccine production demand meticulous cold chain management. The need for effective solutions for filling and freezing the drug substances in both primary and secondary packaging occurs, ensuring their safety and viability throughout the journey.
Single Use Support addresses these challenges with a range of flexible and scalable solutions grounded in single-use technology. The end-to-end processes operate seamlessly on automated homogenization, filling, and freezing platforms.
Process experts and biologic project heads benefit from a safe handling of vaccines. Biologics find secure shelter in single-use bioprocess containers and a corresponding shell as protective secondary packaging, safeguarding the frozen material for storage and transport.
Notably, the utilization of plate-freezing technology becomes instrumental in preserving the highest product viability. With freezing solutions available for various volumes, the adaptability and flexibility provided by vendor-agnostic single-use technologies allow for scalable applications according to specific needs. This integrated approach ensures that the vaccine manufacturing process remains not only efficient but also adaptable to varying scales and requirements.
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