[Whitepaper]: Intravacc: bridging the vaccine development gap

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Intravacc is a renowned, not-for-profit R&D organization with 100+
years’ experience in vaccine
development. We develop vaccines, vaccine processes and vaccine technologies and substantially
reduce the risks and costs involved with developing new vaccines. How? By bridging the gap between
concept and late-stage clinical studies (see figure below). We have all the state-of-the-art facilities in
house to offer you a wide range of solutions. Our latest achievements include the technology transfer of
our Hib conjugate vaccine to four companies in Asia and the technology transfer of our Sabin Inactivated
Polio Virus vaccine to five members of the Developing Countries Vaccine Manufacturers Network.


Intravacc’s expertise is placed in four main programs:
1. Viral Vaccine Technology
2. Bacterial Vaccine Technology
3. Vaccine Design
4. Animal Models and 3Rs

1. Viral Vaccine Technology
For new viral vaccine development, we use established blue-prints and scalable platform production
processes, for example those based on an available scale-down process for IPV. Our proven technologies
are based on Intravacc’s long-standing experience with oral and inactivated poliovirus vaccines and
includes virus seed strains recovery from synthetic viral genome, cell and virus culture technology, virus
harvest and clarification, purification, formulation and freeze-drying, with all analytical assays required
for in-process controls and product release. Our viral vaccine platform makes use of Intravacc’s
established and well characterized WHO pre-qualified Vero cell line. In this way, we can demonstrate
fast-track proof-of-principle of a pilot process for various viral vaccines, as recently shown for Sabin-IPV,
OPV, RSV, EV71, CVA16, and Rota vaccine concepts using a science-based quality by design approach.
This includes manufacturing at cGMP quality level for clinical studies.

2. Bacterial Vaccine Technology
For the development of vaccines against bacterial pathogens, Intravacc has, alongside conjugate vaccine
technologies, designed and developed a unqiue platform based on outer membrane vesicles (OMVs) –
spherical particles with natural adjuvant properties that harbor many antigens. Using genetic
engineering, these OMVs can be decorated with the desired antigen(s) in the required amounts that
maintain their native conformation. Heterologous OMVs are a suitable alternative for pathogens that
require a high containment, that are difficult to cultivate, or contain viral and/or parasitic proteins. The
antigens of choice are placed in an ‘empty’ OMV. We have developed genetic tools to increase yield,
reduce toxicity and to achieve the desired antigenic composition. For this, we use a robust, scalable
GMP production process.

3. Vaccine design
Our broad technological capabilities, including (physico)chemical analyses, molecular biology,
proteomics, immunological read-out and mass spectrometry, allow us to guide innovative vaccine
concepts through the development chain. Advanced LC-MS analysis allows us to provide state-of-theart
knowledge and know-how in protein characterization. Special focus points are vaccine delivery and
vaccine formulation.
As a front runner in applied research on mucosal and intradermal delivery we can create value for
promising delivery technologies. Our formulation team can help to produce safe, affordable vaccines by
using the right excipients. The production of combination vaccines, lyophilization and spray-drying,
stabilization and the use of proprietary adjuvants (like modified aluminum and our detoxified LPS
mutants) can serve to complement your concept.

4. Animal Models and 3Rs
Intravacc follows an active and overall 3R-policy (reduce, refine and replace animal experiments). In
particular, we have been instrumental in the development and distribution of a new paradigm in vaccine
lot release testing, known as the Consistency Approach. To promote the implementation of this
strategy, Intravacc participates in an IMI-funded European consortium on consistency testing.
With more than 100 years of experience and a global network to build on, Intravacc is your partner in
innovative translational vaccinology. You can find more information on www.intravacc.nl.
Or contact us at: businessdevelopment@intravacc.nl.

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