A leading Australian contract manufacture, Luina Bio offers clients the technology, expertise and experience to manage their vaccine production needs
According to the World Health Organisation, the global vaccination rate is nearly 85%[1] and the demand for vaccines continues to grow. Meeting this demand is very challenging as producing vaccines is complicated, costly and requires state-of-the-art technologies and highly skilled personnel. Also, the equipment and processes used to manufacture vaccines are highly regulated.
Developing vaccines
There are several different types of vaccines with each type designed to help your immune system fight off different germs and the infections and diseases they cause.
Scientists take many approaches to designing vaccines against infectious agents. The particular approach is generally determined by the fundamental information about the microbe, such as how it infects cells and how the immune system responds to it. Practical considerations are also taken into account, such as regions of the world where the vaccine would be used.
The following presents some of the options available for developing different types of vaccines.
Live-attenuated vaccines
Live vaccines use a weakened (or attenuated) form of the germ that causes a disease and are very similar to the infection that they are helping to prevent. Because of this similarity, live vaccines elicit strong cellular and antibody responses and can often provide lifelong immunity with only one or two doses.
As they are living, live vaccines usually need to be refrigerated to retain their potency. Therefore, live vaccines may not be the most appropriate choice for developing countries that may lack adequate and widespread refrigeration.
Inactivated Vaccines
Inactivated vaccines are created by killing the disease-causing microbe with chemicals, heat or radiation. Inactivated vaccines are more stable and safer than live vaccines. However, most inactivated vaccines stimulate a weaker immune system response when compared with live vaccines.
Therefore, it usually takes several additional doses (or booster shots) to maintain a person’s immunity and so could be a drawback in areas of the world where people don’t have regular access to healthcare and are unable to receive booster shots on time.
Subunit Vaccines
Subunit vaccines contain only the components, or antigens, of the entire pathogen that best stimulate the immune system. Although this approach can make vaccines safer and easier to produce, it often requires the addition of adjuvants—substances formulated as part of a vaccine—to boost immune responses and enhance the vaccine’s effectiveness. Subunit vaccines can be made by:
- growing the microbe in the laboratory and then using chemicals to break it apart to gather the important antigens; or
- manufacturing the antigen molecules from the microbe using recombinant DNA technology.
Toxoid Vaccines
For bacteria that secrete toxins, the development of a toxoid vaccine might be possible. These vaccines are used when a bacterial toxin is the main cause of illness. By treating the toxins with formalin, they can be de-toxified, called “toxoids,” and then are safe for use in vaccines.
Conjugate Vaccines
The coating around many bacteria possess polysaccharide (a complex carbohydrate) that disguise a bacterium’s antigens so that the immature immune systems of infants and younger children can’t recognize or respond to the infectious agent.
Conjugate vaccines are a particular type of subunit vaccine. They link and position sugar molecules on highly immunogenic antigens or toxoids from the microbe so that the infant’s immune system can recognize the polysaccharides. These linkage helps the immature immune system react to polysaccharide coatings and defend against the disease-causing bacterium.
DNA Vaccines
Researchers have found that when the genes for a microbe’s antigens are introduced into the body, some cells will take up that DNA. This DNA then instructs the host’s cells to produce the antigen molecules. The cells secrete the antigens and display them on their surfaces. Essentially, the body’s own cells become vaccine-making factories, creating the antigens necessary to stimulate the immune system.
Recombinant Vector Vaccines
Recombinant vector vaccines are similar to DNA vaccines. However, instead of naked DNA, the DNA of the infectious agent is incorporated into a “vector” or larger loop of harmless or attenuated DNA, with the latter isolated from a different microbe. The carrier DNA then ferries the antigenic DNA from the infectious agent into the cells of the body, which then use the incorporated DNA to make and present antigens from the infectious agent.
Luina Bio and vaccine manufacturing
The high costs of developing vaccines combined with complex production protocols has driven small and medium-sized vaccine developers to outsource their manufacturing operations to third-party supplies, called contract development and manufacturing organisations (CDMOs). Even large pharmaceutical and biotech companies, with in-house manufacturing capabilities, are entering into long-term relationships with CDMOs to optimise their resources and manage costs.
A leading Australian CDMO, Luina Bio provides vaccine manufacturing services to the pharmaceutical, biotechnology and veterinary industries. Drawing on more than 20 years of contract manufacturing experience, Luina Bio’s scientists have the expertise, training and experience to ensure a successful outcome for the client’s human or veterinary vaccines projects.
Luina Bio’s TGA/APVMA licensed facilities operating to international cGMP standards can provide comprehensive manufacturing solutions for many types of vaccines. In the past, we have manufactured recombinant proteins, whole-cell vaccines, and viral vaccines for human and veterinary product for clients both within Australia and internationally in the United States, New Zealand and Asia.
Luina Bio also provides a dedicated project manager to help coordinate the client’s vaccine project and offers the following services:
- Dedicated containment area
- Flask or fermentation (recombinant vaccines)
- Attenuation or killed preparations
- Antigen capture and stabilization
- Documentation and support services
[1] https://www.who.int/news-room/fact-sheets/detail/immunization-coverage
