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.
Even the most promising vaccines don’t always make it out of the laboratory into large-scale production. We at Intravacc are fully aware of the challenges on the long road of vaccine R&D.
We substantially reduce the risks and costs involved with developing vaccines. How? By bridging the gap between your concept and late stage clinical studies.
Intravacc has all the state-of-the-art facilities available in-house to offer you a wide range of solutions. Our dedicated expert staff work tirelessly at optimizing and innovating not only the vaccines themselves – both viral and bacterial - but also the processes of producing them and technologies for transporting, storing and delivering.
With over 100 years of expertise in vaccines to build on, Intravacc is your partner in innovative translational vaccinology.
News | 14-05-2018
The Dutch Ministry of Health, Welfare and Sport has announced the start of the privatization process of the activities of Intravacc. Collegium Advisors is to act as lead advisor and co-ordinator of the privatization process.
News | 08-05-2018
Provention Bio, Inc. announced today that it has selected Intravacc to lead product development and manufacturing of clinical trial material for Provention’s Coxsackievirus B (CVB) vaccine (PRV-101).
News | 12-12-2017
Hørsholm, Denmark / Bilthoven, the Netherlands, December 11, 2017 – Today, ExpreS2ion Biotechnologies ApS (“ExpreS2ion”) and Intravacc (the Institute for Translational Vaccinology), announc...
The Dutch Ministry of Health, Welfare and Sport has announced the start of the privatization process of the activities of Intravacc. Collegium Advisors is to act as lead advisor and co-ordinator of the privatization process.
Bilthoven, May 8th, 2018 - The Dutch Ministry of Health, Welfare and Sport (Ministerie van Volkgezondheid, Welzijn en Sport or MoH) has announced the start of the privatization process of the activities of Intravacc.
Intravacc (Institute for Translational Vaccinology) has a wide range of relevant expertise in independently developing vaccines from lead concept to clinical phase I/II studies, and has its own product pipeline and patents. Moreover, it provides and contracts R&D services to a range of public and private customers. During the last several decades, Intravacc has positioned itself as a global leader in the development of vaccines aiding in the eradication of Polio and has engaged in the research and development of bacterial and viral vaccines against, amongst others, Respiratory Syncytial Virus (RSV), Shigella, Rotavirus, Hib and DTP.
Intravacc was originally formed to perform public tasks concerning research and development of new vaccines resulting from the ambitions and objectives set out by the Dutch State. The company’s aim is to develop safe, effective and affordable vaccine concepts in order to find sustainable solutions to improve public health worldwide. Intravacc is located in Bilthoven, the Netherlands, where it operates state-of-the-art R&D and Good Manufacturing Practice (GMP) facilities for conducting vaccine research.
As a result of the increasing commercial focus of the organization and its close collaboration with the (global) pharmaceutical industry and Global Health parties such as the World Health Organization and the Bill and Melinda Gates Foundation, MoH decided Intravacc would be better suited in a private setting. In June 2015, the Minster of MoH informed the Dutch House of Representatives on its intent to privatize Intravacc and, has now obtained all required political approval to commence the privatization process in order to secure a suitable prospective buyer.
Collegium Corporate Finance and Valuation Advisors has been appointed to act as lead advisor to the MoH during the privatization of Intravacc. Collegium will aim to inform potential prospective buyers about the timelines and structure of the privatization process. Any contact and all expressions of interest with regards to the privatization process should be expressed via Collegium (Intravacc@CollegiumAdvisors.com).
Contact details: Collegium Corporate Finance and Valuation Advisors,
Joachim Schulz, Managing Director, Tel: +31-10 203 7856.
Correspondence address: Westplein 11, 3016 BM Rotterdam, The Netherlands.
Provention Bio, Inc. announced today that it has selected Intravacc to lead product development and manufacturing of clinical trial material for Provention’s Coxsackievirus B (CVB) vaccine (PRV-101).
Lebanon, NJ, May 7, 2018 – Provention Bio, Inc. (Provention), a clinical stage biopharmaceutical company dedicated to sourcing, developing and commercializing novel therapeutics aimed at intercepting and preventing immune-mediated diseases, announced today that it has selected Netherlands-based Intravacc to lead product development and manufacturing of clinical trial material for Provention’s Coxsackievirus B (CVB) vaccine (PRV-101). France-based L2D Services SARL/Leads- To-Development (L2D) is providing expert development, regulatory and project management support to ensure rapid progress of PRV-101 into clinical development.
CVB, an enterovirus, has been identified as a possible common trigger for type 1 diabetes (T1D) onset. Vaccination of at-risk populations against CVB infection may lead to the prevention or delay in onset of T1D. The CVB vaccine was developed initially by Vactech Ltd. of Finland and licensed to Provention in April, 2017. Provention is planning to initiate first in-human clinical trials in 2020.
Enteroviruses are responsible for an estimated 30 million infections annually in the US. CVB contributes significantly to enteroviral healthcare costs, since it can result in hospitalization and severe morbidity. Usually asymptomatic or presenting as cold-like symptoms, fever, rash, hand-foot-mouth disease, and/or mild gastrointestinal distress, CVB infections can occasionally cause more serious and sometimes lifethreatening illnesses including pericarditis, myocarditis, meningitis and pancreatitis.
Provention, in partnership with Intravacc, Vactech and L2D is now developing its CVB vaccine for large scale manufacture of clinical trial material in accordance with current Good Manufacturing Practices (cGMP). Intravacc was chosen as Provention’s manufacturing partner based on its expertise and excellent track in enterovirus vaccine development, including IPV, sIPV, EV-71, and CV-A16, as well as Intravacc’s state-of-the-art vaccine cGMP production facilities. PRV-101 will be developed using Intravacc’s proven and well-established platform technology, including certain proprietary cell lines and production processes.
Ashleigh Palmer, co-founder and CEO of Provention Bio, stated, “Selecting Intravacc for PRV-101’s cGMP production is an important next step in our plan to initiate a potentially transformative clinical program to develop a vaccine to prevent acute coxsackievirus B infection and, ultimately, prevent or delay the onset of as much as half of the world’s cases of T1D. We welcome this opportunity to work alongside Intravacc, Vactech and L2D to advance our PRV-101 program to the clinic.”
Intravacc’s CEO Thijs Veerman, MSc, commented, “We are very excited to be involved in this project. Intravacc is uniquely positioned to develop cGMP clinical material for this vaccine and ensure its specifications, quality and patient-readiness. We have the necessary knowledge, expertise and experience to advance Provention’s PRV-101 program to the next stage and beyond.”
T1D is a life-impacting chronic disease caused by immune destruction of the insulinproducing cells in the pancreas. Today, there is no cure. The only means for managing this devastating disease is life-long blood glucose monitoring and insulin replacement by way of injection, infusion or, potentially, pancreatic cell transplantation. Global longitudinal studies of more than 200,000 children screened, and more than 17,000 followed, over two decades in Finland by Vactech’s scientific founders and collaborators have identified CVB infection as a likely trigger for T1D onset. From this research, it was discovered that the diabetes process often starts after CVB infection. Insulin-producing cells in the pancreas express specialized receptors used for cellular infection by CVB. As a result, an exacerbated immune reaction against the virus may be involved in triggering the autoimmunity targeting the pancreas and gut, which appears to precede the onset of T1D and associated celiac disease. Importantly, the CVB-related risk of T1D autoimmunity was significantly reduced in children whose mothers previously had a CVB infection, thereby suggesting a transfer of protective CVB antibodies to their offspring via placenta and breast milk. This observation suggests the potential benefit of CVB vaccination for children.
Intravacc, based in Bilthoven, the Netherlands, is an established R&D organisation with more than 100 years’ experience in the optimisation of vaccines, vaccine processes and vaccine technologies. Intravacc has state-of-the-art production facilities and its 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. For more information on Intravacc, please visit www.intravacc.nl.
Provention Bio, Inc. is a clinical-stage biopharmaceutical company leveraging a transformational drug development strategy that is focused on the prevention or interception of immune-mediated disease. Our diverse portfolio was assembled with product candidates that have undergone clinical testing but may have been underdeveloped or deprioritized assets at other companies. Provention’s mission is to in-license, transform and develop clinical-stage, or nearly clinical-stage, therapeutic candidates targeting the high morbidity, mortality and escalating costs of autoimmune and inflammatory diseases including: type 1 diabetes (T1D), Crohn’s disease, ulcerative colitis, lupus, and certain life-threating viral diseases. For more information on Provention Bio, please visit www.proventionbio.com.
Vactech develops and licenses vaccines and novel technologies for vaccines and diagnostics with a pipeline of early stage product candidates focused on Type 1 Diabetes, Celiac Disease, Asthma & Allergy and diagnostics. Vactech is a privately owned company having a track record of collaboration with both industrial and academic partners. Vactech has engaged in strategic partnership with Provention Bio, Inc. especially in the field of preventive Type 1 Diabetes vaccine and related applications. Please see the company's website at www.vactech.fi for additional information.
L2D is a Paris-based company that provides drug development and regulatory affairs support, with a particular emphasis on preclinical development and clinical trial applications. L2D can provide support in the generation and execution of preclinical development plans and has expertise in all aspects of production (CMC), toxicology and safety pharmacology. L2D also has expertise in early stage regulatory affairs including product classification, formal scientific advice with the FDA, EMA or national competent authorities, orphan drug designation requests and writing both EU and US clinical trial applications/INDs. For more information on L2D, please visit www.leadstodevelopment.com.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Provention’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA approvals or clearances and noncompliance with FDA regulations; uncertainties of patent protection and litigation; limited research and development efforts and dependence upon third parties; substantial competition; and our need for additional financing. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Provention does not undertake an obligation to update or revise any forward-looking statement. The information set forth herein speaks only as of the date hereof.
Hørsholm, Denmark / Bilthoven, the Netherlands, December 11, 2017 – Today, ExpreS2ion Biotechnologies ApS (“ExpreS2ion”) and Intravacc (the Institute for Translational Vaccinology), announce the signing of a collaboration agreement. This agreement strengthens ExpreS2ion’s ability to service customers and partners across the full value chain of vaccine development and expands the commercial opportunities for both organisations. Under the agreement, Intravacc will serve as a preferred GMP (Good Manufacturing Practice) partner for ExpreS2ion. The agreement contains no financial exchange between ExpreS2ion and Intravacc. However, it expands the commercial opportunities in the vaccine field for both organisations.
Memorandum of Understanding
ExpreS2ion, a fully owned subsidiary of ExpreS2ion Biotech Holding AB, and Intravacc, an experienced vaccine R&D institute, have signed a Memorandum of Understanding (MoU). The MoU enables ExpreS2ion to service customers and collaboration partners across the full value chain of development of vaccines, from discovery up till GMP production and clinical trials. Under the agreement, Intravacc will serve as a preferred GMP partner for ExpreS2ion. Serving as a reference for expanded customer outreach, the MoU contains no financial exchange between ExpreS2ion and Intravacc. However, it expands the commercial opportunities in the vaccine field for both organisations.
ExpreS2ion CEO Dr. Steen Klysner comments
“We are very satisfied to expand ExpreS2ion’s capabilities into the manufacturing of vaccines through the establishment of a preferred partnership with Intravacc. This strategic alliance increases ExpreS2ion’s service offerings and continues our repositioning into a one-stop solution provider for vaccine developing SMEs and Pharma companies.”
Intravacc CEO Thijs Veerman Msc comments
“We are proud to serve as a preferred GMP partner for ExpreS2ion and its clientele. Intravacc offers one-stop solutions for GMP production and clinical development and has a strong track record in the technology transfer of vaccine products and knowhow to our partners. Our experience with the development and successful technology transfer of vaccines such as Haemophilus influenzae b and Sabin inactivated Polio vaccine to vaccine manufacturers has paved the way for a fast and product oriented route to market.”
About Intravacc
Intravacc, based in Bilthoven, the Netherlands, is an established R&D organisation with more than 100 years’ experience in optimisation of vaccines, vaccine processes and vaccine technologies. Intravacc has state-of-the-art production facilities and its 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. More information at www.intravacc.nl.
For further information about Intravacc, please contact:
Thijs Veerman Msc, CEO
Telephone: +31 30 7920445
E-mail: thijs.veerman@intravacc.nl
Certified Adviser
Sedermera Fondkommission is appointed as Certified Adviser for ExpreS2ion.
For further information about ExpreS2ion Biotech Holding AB, please contact:
Dr. Steen Klysner, CEO
Telephone: +45 2062 9908
E-mail: sk@expres2ionbio.com
This press release contains information that ExpreS2ion is obligated to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication through the agency of the contact person set out above on December 11, 2017.
ExpreS2ion Biotechnologies ApS is a fully owned Danish subsidiary of ExpreS2ion Biotech Holding AB with company register number 559033-3729. ExpreS2ion’s unique proprietary platform technology, ExpreS2, is designed to enable accelerated, cost effective development and robust production of complex proteins for new vaccines and diagnostics. Since founded in 2010, more than 250 proteins involved in e.g. malaria and Zika were produced in collaborations with research institutions and companies with a superior efficiency and success rate. ExpreS2ion also develops competitive virus-like-particle based vaccines through its joint venture AdaptVac, which was founded in 2017.
