Based on a long-standing historic track-record, we have state-of-the-art and readily available vaccine platform technologies and development capabilities. In recent years, we further developed these scale-able platform technologies that can be applied to quickly develop vaccines.
In our state-of-the-art facilities, our experienced R&D institute takes your discovery up to Phase I/II clinical trials. Furthermore, we share and transfer our knowledge and technologies to public and private partners worldwide and work on collaborative R&D.
Our aim is worldwide equity in access to affordable vaccines. Achieving our aim requires a wide range of expertises in the field of vaccinology and intense interdisciplinary collaboration.
Intravacc provides the know-how and tools to support the development of innovative ideas from universities and start-ups into concept products that are interesting for pharmaceutical companies who are able to bring vaccines to the market. These crucial development phases from research up to clinical phase I/II studies ask for highly professional expertise and infrastructure.
Through co-development and by transferring vaccine technologies and knowledge, we partner with vaccine manufacturers worldwide to develop or improve their vaccine production processes and analytical assays, thereby enhancing both the quality and the quantity of global vaccine manufacturing.
Our programs and projects are supported by the Netherlands Government, the European Union, the World Health organization (WHO) and the Bill and Melinda Gates Foundation.
With our Polio Expertise Center, we contribute to the eradication of polio worldwide. We use our proven platform technologies to swiftly develop an affordable, high quality polio vaccine in accordance with EMA and WHO requirements.
Polio is a severe disease and once infected, there is no cure. Prevention is the key word, and fortunately there are effective vaccines against polio. To prevent future outbreaks, vaccination will remain necessary, even after eradication. To increase polio vaccine availability and accessibility, on assignment by the World Health Organization, we developed a new inactivated polio vaccine.
Intravacc serves as an expert center to improve your polio vaccine by:
We use a science-based quality by design (QbD) approach following ICH Q8 and ICH Q11 guidelines for low cost-of-goods virus vaccines based on an available scale-down process for inactivated polio vaccines.
By using the weakened and less transmissible Sabin polioviruses in production, the risk of facility related outbreaks can be reduced significantly. Therefore, our technology allows manufacturers to securely produce Sabin-IPV (Inactivated Polio Vaccine), and in this way also actively contribute to the GPEI goals for polio eradication.
In recent clinical studies the new Sabin-IPV was successfully shown to be safe and immunogenic in both adults and infants.
The implementation of post-eradication containment requirements (GAPIII) may influence the activities in future polio virus vaccine research, and in production facilities. Therefore, alternative poliovirus strains and methods are actively being developed that could reduce the risk of facility-associated transmission and may require lower levels of containment. For example, new Oral Polio Vaccine type 2 (nOPV2) strains are being developed as commissioned by the Bill and Melinda Gates Foundation. Currently, based on our established platform technologies, Intravacc is producing the polio virus nOPV2 Master- and Working seed lots in this project under cGMP.
We have longstanding historic track record in transferring knowledge and technology, for example regarding Hib conjugate vaccine, and influenza vaccine (WHO program). Currently, our Sabin-IPV production technology, including the product specific assays, is actively being transferred by hands-on training to local vaccine manufacturers in emerging economies. For example, in this way China, South Korea and India are enabled to safely produce the Sabin-IPV vaccine to vaccinate their local population and for international supply to UNICEF. We are open for new collaborations, and licensure of our unique Sabin-IPV technology.
In parallel, continued process optimization and modernization is ongoing. This will contribute to increase the affordable Sabin-IPV quantities available for the post-eradication era.
The Sabin-IPV vaccine is developed on our proven Vero cell platform technology. These platform technologies can also be applied to quickly develop several other viral vaccines to control emergency outbreaks.
The use of laboratory animals often remains a necessity in biomedical research. Intravacc acknowledges that laboratory animals are sentient beings and as such, have an intrinsic value. Therefore we have an active research program on Replacing, Reducing and Refining animal use; the so-called 3Rs.
It is our ambition to replace the use of animals for routine lot release testing of (classical) vaccines by innovative animal-free techniques and to improve the scientific substantiation of these methods.
To achieve this, Intravacc is developing several methods based on the 3R’s (reduction, refinement & replacement) of which some have already been adopted by the European Pharmacopoeia. In addition, we are a front runner 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, we participate in a IMI-funded European consortium on consistency testing.
We have a profound interest to cooperate within both public and industrial partnerships to improve the 3R research, that currently focusses on:
Intravacc acknowledges that laboratory animals are sentient beings and as such, have an intrinsic value. Therefore, we use use high quality and welfare standards for animal experimentation.
We have a long standing track record in the performance of animal experiments. We are specialized in animal model infectiology and vaccinology. Our Animal Research Center has three state-of-the-art animal laboratory facilities for housing different species of experimental animals, e.g. (transgenic) mice, rats, cotton rats, ferrets, guinea pigs, rabbits etc.
All species can be housed in accommodations with different containment restrictions and biosafety levels. The flexibility of the animal facilities (i.e various closed compartments and 65 stainless steel isolators) offers the possibility to create tailor-made conditions for each animal species under the optimal housing restrictions and biosafety level BSL-2/DM-II and BSL-3/DM-III.
We pay specific attention to guarantee the microbiological status of the animals during the study. With ISO 9002 and ISO 14001, GMP and GLP quality requirements we can ensure that animal experiments are carried out at a very high quality level. All animal experiments are performed in accordance with the Dutch Law of animal experiments (Wod) and the European Directive 2010/63/EU. The ethical permissibility of the experiment is assessed before the start of each study and during the experiments the animal welfare is monitored by experts according the Wod.
To ensure state of the art expertise and knowledge, we offer innovative research and have several development programs on vaccine delivery and formulation.
We are continuously working to optimize vaccine design and monitoring strategies. The pillars to support translational vaccinology comprise of:
KNOWLEDGE - What should a certain vaccine ideally look like and why?
TOOLS & ASSAYS - How to optimize and monitor vaccine development?
The way this is accomplished by Intravacc varies from collaboration with research institutes/universities/companies to a customer service, examples include:
The ideal vaccine is highly efficacious, easy to administer, thermostable and capable of providing life-long immunity against a given pathogen. Unfortunately, not all vaccines are ideal.
We aim to optimize the efficacy of existing and future vaccines. In addition, optimization of the administration of vaccines can lead to thermostable, pain free and affordable vaccination. Using its proven track record, Intravacc focuses amongst others on improved and innovative techniques for subcutaneous, intramuscular, dermal and mucosal vaccination. By combining innovation and knowledge into a product-oriented approach Intravacc contributes to improved vaccine delivery worldwide.
The Intravacc Vaccine Delivery Platform focuses with its partners on
Our experienced team is working on the stabilization of vaccines and diagnostics by delivering an appropriate formulation suitable for storage in either a liquid or a dried presentation. We offer various drying methods such as spray-drying, freeze-drying, vacuum-drying or foam-drying depending on your needs. We will execute the work in an ML-II environment and are experienced in formulating and drying of genetically modified microorganisms.
We have a broad arrange of equipment, amongst which are:
Intravacc strives for an efficient optimization of drying processes with a minimal risk for failure to guarantee product excellence. Therefore, we offer the following services:
Intravacc is an experienced, not-for-profit R&D organization. We optimize vaccines, vaccine processes and vaccine technologies. Our aim is to substantially reduce development risks and costs of new vaccines in order to contribute to global health and equity in access to vaccines worldwide.
We achieve our aim by developing and improving vaccine design, production processes, analytics and technologies. In our state-of-the-art facilities, our experienced R&D institute takes your discovery up to Phase I/II clinical trials. Furthermore, we share and transfer our knowledge and technologies to public and private partners worldwide and work on collaborative R&D.
Our client base:
Our institute in short:
Intravacc is een toegepast wetenschappelijk onderzoekinstituut dat onderzoek doet naar nieuwe vaccins. Door Intravacc worden enerzijds veelbelovende ideeën uit de wetenschap beschermd en verder geholpen op het pad naar vaccins die waardevol zijn voor zowel de volksgezondheid als het bedrijfsleven. Anderzijds wordt door Intravacc de beschikbare kennis op het gebied van vaccinontwikkeling en -productie ingezet om R&D opdrachten voor klanten uit te voeren. Het instituut rekent zowel de (inter)nationale overheid als bedrijven, onder andere binnen de innovatieve farmaceutische industrie, tot haar klanten. In het komend jaar zal het instituut worden verzelfstandigd, dus volop in beweging.
De afdeling Analytical Development and Formulation zoekt een
36 uur per week
Vacaturenummer: INT054
De functie bestaat uit twee taken, nl. coördinatie van QC activiteiten en Technology Transfer van QC activiteiten.
Coördinatie QC activiteiten
Intravacc werkt op basis van projecten en kent derhalve geen routine productie. De QC activiteiten zijn ondergebracht bij de afdeling ADF (Analysis, Delivery & Formulation). Bij de bereiding van producten die gebruikt worden in een humane klinische studie dienen de testen uitgevoerd te worden volgens de vigerende GMP/GLP eisen. In het algemeen worden product specifieke testen door Intravacc ontwikkeld en uitgevoerd, terwijl generieke testen veelal worden uitbesteed aan een contract lab.
Binnen de afdeling ADF ben je verantwoordelijk voor de kwaliteitscontrole (vanuit GMP perspectief: ‘hoofd QC’) en de kwaliteitsborging van het analytische deel van projecten met (pre-)GMP status. Omdat de producten die Intravacc onder GMP maakt altijd experimenteel zijn (maar wel voor humaan gebruik) is het analytisch arsenaal breed en zijn de QC-teams wisselend van samenstelling, waarbij je wel beschikking hebt over een drietal dedicated QC-medewerkers.
QC Technologie Transfer (TT)
Intravacc heeft Technology Transfer (TT) programma’s, waaruit kennis over processen en testen wordt overgedragen aan partners. Vaak zijn dit lokale vaccinproducenten. Je ondersteunt de doelstellingen van de TT programma’s door een bijdrage te leveren bij het overbrengen van test gerelateerde kennis Je fungeert op QC gebied als intermediair tussen testontwikkelaars bij Intravacc en klanten. Hoewel de functie zich richt op assays is enige kennis over de productieprocessen belangrijk
Functie-eisen
• Een relevante WO vooropleiding aangevuld met werkervaring en/of deskundigheid.
• Ervaring met analyses van complexe biologicals zoals vaccins.
• Ervaring met QC en GMP werkwijze en regelgeving.
• In staat het brede arsenaal van testen te overzien, de essentie van assays te begrijpen en te relateren aan GMP-regelgeving.
• Beschikt over kwaliteiten om een (kleine) groep aan te sturen.
• Weet op klantgerichte wijze doelen te bereiken binnen een multiculturele context.
• Planmatig, resultaatgericht, accuraat en kostenbewust kunnen werken.
• Communicatief vaardig.
• Je kunt zowel zelfstandig als goed in een team werken.
• Goede taalbeheersing van het Nederlands en het Engels in woord en geschrift.
Ons aanbod
Het salaris is afhankelijk van opleiding en relevante ervaring tot maximaal schaal 12.
Het betreft een nieuwe functie in onze organisatie welke gezien kan worden als groeifunctie.
Je wordt aangesteld in tijdelijke dienst voor een periode van 12 maanden met de mogelijkheid tot verlenging.
Informatie
Nadere inlichtingen kun je ontvangen bij Prof.dr. G. Kersten, wetenschappelijk directeur,
telefoon: 030 7920460
Solliciteren
Je sollicitatie kun je tot 27 augustus sturen naar personeelszaken@Intravacc.nl
News | 04-05-2017
We are glad to welcome Thijs Veerman as CEO a.i. for Intravacc.
From 2001 until 2007, Thijs was General Director of the Netherlands Vaccine Institute (NVI), the predecessor of Intravacc. Betw...
News | 13-04-2017
Jan Hendriks, one of Intravaccs senior scientists, recently successfully defended a PhD thesis in the social sciences on the global impact of public sector vaccine manufacturing in The Netherlands.
News | 24-01-2017
Intravacc congratulates CEPI (Coalition for Epidemic Preparedness Innovations) with its launch on 18 January 2017.
With the launch of CEPI during the World Economic Forum in Davos a new glo...
We are glad to welcome Thijs Veerman as CEO a.i. for Intravacc.
From 2001 until 2007, Thijs was General Director of the Netherlands Vaccine Institute (NVI), the predecessor of Intravacc. Between 2007 and 2016 Thijs held the position as CEO for the medical diagnostic laboratory Star-MDC, after which he choose for self-employment for interim CEO functions. When approached for the CEO function at Intravacc he gladly accepted.
Thijs Veerman: “I feel privileged to be at Intravacc in this phase of the organization. On our road to privatization due in 2018, we have a multitude of opportunities. Intravacc is an institute with great potential. Our capacity for translational research, our multi-disciplinary approach and our proven R&D platforms in combination with our excellent scientific staff make us an attractive partner. We bridge fundamental research in vaccines into a “proof of concept”. With our extensive track record in vaccine development, we are committed to contribute, together with our (future) partners, to global health”.
Intravacc offers a wide and in- depth range of vaccine related R&D-programs. Over 130 professionals cover more than one hundred years of know-how in vaccine development and technology transfer. With a proven track record in R&D, Intravacc transfers vaccine technology - including polio, DTP, Influenza, and Hib vaccines - worldwide since the seventies. Intravacc has an extensive network of researchers, vaccine manufacturers and control authorities worldwide. In Bilthoven, the Netherlands, we have a small scale, state-of-the art production infrastructure that covers the entire vaccine value chain under GMP conditions.
tel: +31 (0) 30 7920 300
thijs.veerman@intravacc.nl
European Immunization Week 2017
24–30 April 2017
European Immunization Week (EIW) is celebrated across the European Region every April to raise awareness of the importance of immunization for people’s health and well-being. Under the slogan "Vaccines work" EIW 2017 will focus on the need for and benefits of immunization at every stage in life.
Jan Hendriks, one of Intravaccs senior scientists, recently successfully defended a PhD thesis in the social sciences on the global impact of public sector vaccine manufacturing in The Netherlands.
After documenting several historical cases of vaccine development, and technology transfer programs , Jan Hendriks concludes that the Dutch public sector vaccinology had a hitherto hardly acknowledged but profoundly positive impact on the global vaccine system that aims to increase access to vaccines in low and middle income countries. From a societal perspective this study suggests that a divergence between national policies and practices among different ministries leads to missed opportunities for global health.
Here is the link to the thesis
Intravacc congratulates CEPI (Coalition for Epidemic Preparedness Innovations) with its launch on 18 January 2017.
With the launch of CEPI during the World Economic Forum in Davos a new global partnership is born CEPI aims to prevent epidemics with emerging infectious diseases by developing new vaccines that could be deployed rapidly during outbreaks. Intravacc fully embraces this new initiative and aims to apply its adaptable vaccine technologies to enable a quick response to previously unknown pathogens. Full press release.
