From the first inspiration in the late 18th century to gene-based DNA and RNA vaccines and novel cancer immunotherapies, vaccines teach the body’s natural defences to target unwanted bacterial, viral and cellular threats. The antigens that have been used to form the foundation of this instruction include whole bacteria or virus, and sub-units such as polysaccharides or proteins, and these may be conjugated to additional proteins or combined with other adjuvants to enhance the immune response.
This diversity in the type of vaccine antigen, along with the inherent variation in the targets, have created challenges for vaccine manufacturers when compared to a relatively small number of platform processes that exist for other biotherapeutic production processes. Smaller batches and facilities configured for multi-product manufacturing require responsive production systems to reduce lead times and production costs. Accelerating vaccine development and manufacturing by coupling research advances in vaccine technology with systems that support agility through a Quality by Design approach is critical to deliver life-saving immunizations to those in need globally.
Antigens can be generated ex-vivo, directly from the target cell or virus, or indirectly via recombinant expression systems. Increasingly, research looks to ways to generate antigens in-vivo via the genetic modification of cells. This genetic modification can be achieved using DNA or RNA, which are themselves generated via an expression process (pDNA production) or chemically-synthesized (mRNA).
Each class of vaccine presents specific process development and manufacturing challenges, and the scale of production varies depending upon the targeted disease. As a result, there is no single vaccine manufacturing approach. There are, however, flexible technologies that can meet each of the challenges during process development, and at GMP scale. These customizable technologies can be applied separately, but can also be combined to design robust, integrated, flexible platforms that support rapid process development and safeguard the quality of life-protecting vaccines, where closed-systems and aseptic processing are essential.
Our innovative process technologies have been an important contributor to the success of many vaccine production processes, and we are constantly working throughout the industry to enhance our solutions to meet your vaccine development and manufacturing challenges. Our Scientific and Laboratory Services (SLS) teams are available to work with you to create a platform configuration which meets your specific vaccine production needs.
Contact us today to discuss how we can help you to get up and running quickly or drive efficiencies in your vaccine production processes.
Vaccine Type |
Antigen |
Typical Process |
Nucleic Acid Vaccines |
Plasmid DNA (pDNA) Messenger RNA (mRNA) Recombinant vector vaccines |
Fermentation Chemical synthesis Cell culture |
Recombinant Vaccines |
Recombinant protein Recombinant virus |
Cell culture |
Sub-Unit Vaccines |
Recombinant protein Polysaccharides and Peptides Conjugates |
Cell culture (mammalian/ insect) Fermentation (bacterial/yeast) |
Bacterial Toxoid Vaccines |
Toxoid proteins |
Fermentation |
Whole Cell Vaccines |
Live attenuated virus Live attenuated bacteria |
Mammalian cell culture Microbial cell culture |
Inactivated bacteria Inactivated virus |
Microbial cell culture Egg-based/mammalian cell culture |
Literature Library
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Flexible Platform Solutions Overcome Vaccine Production Challenges
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