What are novel methods in vaccine manufacturing?

Vaccine manufacturing is constantly evolving: Advancements like mRNA vaccines, recombinant proteins, and innovative delivery systems help to do battle with all kinds of pathogens and play an integral part in disease prevention. These methods offer improved efficacy, swift response, and scalability.

Discover how novel vaccines reshape immunology, fortifying defenses against health threats. In this article, we will examine the potential impact of these advancements on the future of preventive medicine.

Current types of vaccines on the market

In the course of time, there have been tremendous changes in the way vaccines are developed, manufactured, stored and shipped. This is also due to the rise of new technologies on which vaccines are based – highly sensitive DNA molecules and other biologics as well as today’s demands on vaccine manufacturing and safety make it necessary to employ new technologies and procedures that can cope with these requirements.

But what are the types of vaccines that require such efforts in their processing? In the following chapters, we will explore some of the most important types of vaccines currently on the market.

Live-attenuated vaccines

Live-attenuated vaccines employ weakened, yet live, forms of pathogens to induce immune responses. Production involves reducing pathogen virulence, typically through genetic modifications or prolonged culturing. Upon vaccination, these weakened pathogens replicate in the body, mimicking natural infections, and prompting robust immune reactions. Examples include measles, mumps, rubella, and oral polio vaccines.

Their effectiveness stems from mimicking natural infections, conferring long-lasting immunity. However, their application might pose risks for immunocompromised individuals. Live-attenuated vaccines remain crucial in preventing diseases like measles and polio but require careful consideration due to their live nature.

Read more: How were vaccines developed in the past?

Recombinant protein vaccines

Recombinant protein vaccines function through genetically engineered proteins that trigger immune responses. Production involves inserting target antigen genes into host cells to generate these proteins. Devoid of infectious elements, they stimulate immune responses post-vaccination.

Their applications range widely, from Hepatitis B surface antigen used in Hepatitis B vaccines to the HPV virus-like particles employed in HPV vaccines.

mRNA vaccines – major breakthrough in immunology

mRNA vaccines epitomize a revolutionary shift in immunological strategies. Their core mechanism involves utilizing messenger RNA to incite immune responses, a departure from traditional vaccine methodologies. In their development, precise genetic instructions are encapsulated within specialized vector systems, facilitating their delivery into cells.

Upon administration, these mRNA instructions prompt cells to produce harmless snippets of the target pathogen's proteins, initiating an immune response. Notably, this approach doesn't involve the live virus and doesn't integrate into the cell's DNA. This adaptability allows for swift modification, crucial in combating emerging variants.

In application, the versatility of mRNA technology shines. The potential of mRNA vaccines spans a spectrum of infectious diseases, offering a platform for rapid response vaccine development. This adaptability, combined with their ability to elicit robust immune reactions, positions mRNA vaccines as a transformative tool in preventive medicine, poised to address evolving health challenges.

Novel approaches and ongoing developments in vaccine manufacturing

Exemplified by the vaccine types mentioned above, the need for precise and reliable manufacturing solutions is an integral part of today’s vaccine manufacturing market. Novel methods in vaccine manufacturing are being continuously improved and adopted by vaccine manufacturing companies in order to meet these demands and to make vaccine production as safe and efficient as possible.

Novel delivery systems: viral and non-viral vectors

One aspect of modern vaccine manufacturing is the choice of the delivery system that is used to transport vaccine components into the body.

Novel delivery systems encompass viral and non-viral vectors. Viral vectors utilize modified viruses to transport genetic material into cells, leveraging their natural ability to invade. Non-viral vectors, like liposomes or lipid nanoparticles (LNPs), encapsulate genetic material, facilitating its entry into cells without using viruses.

In mRNA vaccines, these delivery systems are crucial. Viral vectors, such as adenoviruses, deliver mRNA into cells, while lipid nanoparticles serve in non-viral approaches, encapsulating mRNA to ensure its safe passage into cells. Their role lies in facilitating efficient mRNA delivery, ensuring its stability and protection until it reaches the target cells, thereby enhancing vaccine effectiveness and immune response.

While these particles are fit to carry genetic information to target cells when administered, they are neither able nor designed to sufficiently protect DNA or RNA ex vivo, e.g. during storage and shipping. Therefore, they do not substitute advanced vaccine processing solutions.

Controlled freezing of valuable biologicals

Temperature is a main consideration to be made when producing, storing and shipping vaccines. Although there are several examples that do not require special attention to temperature control – when a refrigerator is sufficient to satisfy their temperature requirements –, many modern vaccines are kept at ultra-low temperatures in order to keep them safe and effective.

However, extreme temperatures as low as -80 °C pose significant stress to both the drug substances and the bioprocess containers subjected to such freezing process: It is vital to control the decrease in temperature in order to prevent damages that might affect on the usability of a vaccine.

Although ultra-low temperature storage freezers are at the heart of vaccine storage at extremely low temperatures, it is not sufficient to simply place vaccine containers in such a device and subject them to an uncontrolled freezing process. Instead, there are different methods available that are suitable for vaccine freezing.

In contrast to traditional approaches like blast freezing, methods based on plate freezing offer the possibility to perform fast and controlled freezing processes on different levels. These fast and controlled freezing rates can be applied on different volumes, thus making it not only a safe, but also a scalable freezing method. And although this approach is not entirely new, its latest adoption in large-scale mRNA vaccine manufacturing in the face of the COVID-19 pandemic illustrated it as a future-proof freezing method.

Automation for reduced manual interventions

One aspect that becomes more and more dominant in biopharmaceutical processes in general, thus also in vaccine manufacturing, is automation. Rather than being an independent manufacturing method on its own, it has an enormous impact on every vaccine manufacturing steps and therefore shapes various production methods.

This, for instance, is true for fluid management in vaccine manufacturing: Both the individual components and the finished product need to be processed not only with great precision, but also reproducibly and with as little risks for contamination as possible.

But also other tasks profit from the reduced need for manual intervention: Steps like sample preparation, freezing, packaging and labelling can be automated in order to allocate specialized human resources to the areas they are indispensable at.

Biomanufacturing for vaccine production – with single-use technologies

Along the most crucial stages in vaccine development, Single Use Support's innovative solutions help manufacturers in improving vaccine production with single-use technologies.

The RoSS.FILL platform automates fluid management, streamlining processes by precisely filling vaccine components into single-use bags. This automated fluid management solution for vaccine manufacturers ensures accuracy, reducing human error and contamination risks.

Additionally, the RoSS.pFTU platform solution for plate freezing optimizes complex freezing processes. It employs single-use plate freezing technology, enhancing efficiency and maintaining vaccine integrity during freezing by reducing damaging effects like cryoconcentration.

Single Use Support's solutions enhance reliability, product quality and sterility, essential in vaccine manufacturing, empowering streamlined, efficient, and sterile production processes for crucial vaccines.