Bridging the gap
Research

Research

Intravacc develops innovative platforms and methods to improve the effectiveness, stability and safety of vaccines.

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Intravacc is continuously investing in R&D platforms to facilitate vaccine development. Early development includes vaccine strain design to generate bacterial, viral and cellular seeds for efficient vaccine production.

We also carry out studies on adjuvants and delivery systems, resulting in safe products that are efficacious.

Our successful R&D efforts are then further developed into services we offer to clients.

To investigate the efficacy of vaccines, Intravacc performs immunological research to unravel the mechanisms of action of vaccine concepts. These immunological assays are used during preclinical and clinical stages.    

 

Our expertise includes

  • Immunology
  • Molecular biology
  • Animal models
  • Systems vaccinology
  • Adjuvants
  • Vaccine delivery

 

 

 

 

Want to know more? Contact us at businessdevelopment@intravacc.nl

 

Process Development

Process Development

Intravacc develops bacterial and viral vaccines from discovery to phase II clinical trials. We use our own advanced technologies, such as Vero cell line and the OMV platform.

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We can apply our long-standing and extensive experience in vaccine development to design rational and modelled processes together with our clients.

Using mathematical models we can safely scale from lab to commercial scale bioreactors.

 

Viral vaccine R&D

Focusing on the treatment or prevention of viral diseases such as Polio, Respiratory Syncytial Virus, Enterovirus, Influenza, Rabies and Rotavirus. We have access to a qualified Vero cell line and specialized equipment to perform research for WHO, the Dutch Ministry of Health and collaborate with other parties.

 

Bacterial Vaccine R&D

Focusing on Conjugate vaccine technology (for vaccines for Hib and Shigella) and Outer Membrane Vescicles (OMV) technology (Pertussis, Meningococcal B, Lyme disease and Tuberculosis research)

 

 

Main features

  • Established cGMP Vero cell line
  • Technology platform suitable for highly purified inactivated and live-attenuated vaccines
  • OMV-based vaccine technology platform suitable for heterologous antigen expression
  • State-of-the-art production technologies (including single-use and re-usable equipment)
  • Highly qualified BSL-2 and GxP trained personnel
  • Experience in Design of Experiments (DoE), and multiparametric data analysis
  • High-throughput methods for both Up-stream and Down-stream processing
  • Animal Component Free and Chemically Defined processing as standard methods
  • Tested processes to assure process robustness and reproducibility
  • Full panel of analytical capabilities for in-process controls
  • Scalable processes from 2 mL to pilot-scale and commercial manufacturing scale
  • Experience in Technology Transfer of vaccine production processes
  • CMC consulting capacities

 

Check out our factsheets:

Hand Foot Mouth Disease

Hib

Nonamen

OMVs

OMV Pertussis

RSV

Sabin IPV

Vero cells

 

Want to know more? Contact us at: businessdevelopment@intravacc.nl

Assays

Assays

Intravacc offers assay development and vaccine characterization services. We specialise in immunoassays, molecular biology methods, physicochemical analyses, and biological assays.

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Assays to prove the quality of a new vaccine

The quality is a decisive factor in the development of new vaccines. Intravacc uses multiple instructive assays and innovative techniques to guarantee the quality of intermediates and finished product. Our tests focus on the composition, concentration, efficacy, purity, safety, stability and identity of the new vaccine candidate.

 

Immunoassays

  • ELISA (direct and capture assays for antibody titres in sera and antigen concentrations in vaccine formulations)
  • Multiplex Immunoassay (cytokines, antibody titres against multiple antigens, antigen concentrations in combination vaccines)
  • Biosensor analysis (epitope integrity, epitope mapping, affinity measurements, calibration free concentration analysis)
  • Immunoproteomics (identification of immunogenic proteins, B-cell epitopes and naturally processed T-cell epitopes by mass spectrometry)

 

Molecular biology methods

  • qPCR (quantification of viruses and bacteria by real time Polymerase Chain Reaction)
  • Deep sequencing (identity, sequence and genetic changes of viruses)

 

Physicochemical analyses

  • Mass spectrometry (identity, quantity, purity and chemical modifications of antigens, host cell proteins)
  • 2-D electrophoresis (antigen composition )
  • Fluorescence spectroscopy (conformation and aggregation of antigens)
  • Circular dichroism (secondary and tertiary structure of antigens)
  • Differential scanning calorimetry (denaturation temperature of antigens)
  • particle analysis by Dynamic Light Scattering (DLS), Field Flow Fractionation - Multiangle Laser Light Scattering (FFF-MALLS) 

 

Analytical techniques

  • HPLC (amino acid determination, residual phenol, monosaccharides, oligosaccharides, excipients)
  • GC (LPS analysis, phospholipids)
  • NMR (medium composition, metabolite analysis, chemical composition, impurities, excipients)

 

Biological assays

  • CCID50 (active virus titre)
  • Vero cell assay (residual toxin activity)

 

Want to know more? Contact us at: businessdevelopment@intravacc.nl

Animal models

Animal models

Intravacc is one of the leading players in global 3R research (reduce, replace and refine animal experiments).

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We have developed several new methods, some of which were accepted 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 an IMI-funded European consortium on consistency testing.

 

Research focus:

  • Cell-based in vitro models, pysico-chemical techniques and immunochemical assays
  • Development of in-vitro assays
  • Transgenic mouse model for neurovirulence testing of OPV or Sabin-IPV lots

 

Achievements include:

  • Vero cell tests replacing the specific toxicity test in guinea pigs (diphtheria vaccine)
  • Serological tests replacing challenge procedures in potency testing (diphtheria and tetanus vaccine)
  • The use of human endpoints replacing lethal/severe clinical endpoints 

 

Check out our factsheet on our 3R research

 

Want to know more? Contact us at: businessdevelopment@intravacc.nl

Pilot-scale production

Pilot-scale production

Intravacc is home to a GMP facility for production of vaccines on pilot scale. This includes a state-of-the-art 100 m2 C/BSL-2 cleanroom.

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Intravacc has years of experience in producing GMP batches for phase I and II clinical studies of viral and bacterial vaccines.

We have all the required equipment at our disposal for Upstream and Downstream Processing, including bioreactors of up to 100 liter.

This means we can offer a complete CTM production trajectory from seed lot production till released clinical batches.

 

Facilities

  • Fully adaptable cleanrooms
  • 100m2 class C/BSL-2 cleanroom for active processes
  • 25m2 class C cleanroom for inactive processes
  • Dedicated cleaning & sterilization department

 

Want to know more? Contact us at: businessdevelopment@intravacc.nl

Clinical & Regulatory

Clinical & Regulatory

Our inhouse clinical and regulatory scientists form part of each project team that develops a new vaccine. They offer regulatory support right from the start.

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Innovative vaccines are mostly complex products for which there is often no clear regulatory guidance available. That is why our Regulatory and Clinical Affairs (RCA) team is involved in the development of these products right from the start.

By taking into consideration the regulatory restraints and requirements in an early phase of development, a lean transition to the next phase towards a marketed product can be made. 

Our team provides regulatory support in vaccine development projects through early involvement, assessment of potential regulatory requirements, preparation of risk assessments and by seeking informal or formal scientific advice with national competent authorities.

Support varies from the preparation of pharmaceutical, preclinical, and clinical development plans and reports, to the submission of relevant regulatory dossiers (IMPD/IND, CTA) to health authorities.

 

CMC activities

  • Raw materials assessment
  • Quality Target Product Profile-design, define product specifications
  • Gap analyses and risk assessments (e.g. Viral safety/TSE/Impurities/GMOs)
  • Design of program for stability testing
  • Comparability studies

Nonclinical

  • Pre-clinical evaluation of vaccine immunogenicity, efficacy
  • Coordination of non-clinical toxicology and safety studies
  • Non-clinical development plan

Clinical

  • Product Profile design
  • Clinical Development Pathway advise
  • Clinical study design
  • CRO selection and management

 

Want to know more? Contact us at: businessdevelopment@intravacc.nl

Co-Development with partners

Co-Development with partners

We are always open to work closely together with academia, public health organizations (WHO, BMGF), and biotech and pharmaceutical companies. This way, we benefit from each other's strengths in developing and innovating vaccines.

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Are you looking for an experienced partner who can take your discovery to the next level of preclinical research?

Are you looking for a partner with GMP facilities, who can produce clinical lot material for your toxicity studies and phase I/II clinical trials?

Are you looking for a partner with a patent portfolio covering a variety of vaccine leads, novel vaccine technologies and adjuvants?

We are happy to discuss these and other possibilities for collaboration and co-development.

 

Vaccine concepts/technologies available for licensing

  • RSV
  • EV71
  • Pertussis
  • Alzheimer
  • LPS-mutants
  • Vero cells
  • MenB
  • Hib-conjugate vaccine

 

Want to know more? Contact us at businessdevelopment@intravacc.nl

About Intravacc

Intravacc is an experienced R&D organization with a proven track record in vaccinology of over 100 years. We have a wide range of expertise to independently develop vaccines from lead concept to clinical phase I/II studies as wel as our own product pipeline and patents.     

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  • a wide range of science-based, one-stop-shop solutions
  • state-of-the-art facilities on site
  • Bacterial and Viral vaccines
  • OMV technology
  • Vero cell platforms
  • Innovative vaccine design
  • 3R research

Check out our factsheet on Intravacc 

Want to know more? Contact us at: businessdevelopment@intravacc.nl

 

 

 

 

 

FActsheet vaccine

Factsheets

News

Intravacc and CDBIO sign a research and license agreement to further develop and commercialize a Meningococcal B vaccine

News | 28-12-2018

Intravacc and CDBIO today announced that they have signed a research and license agreement to further develop a vaccine against Meningococcal type B based on Intravacc’s proprietary Nonamen® vaccine technology.

Both parties will collaborate to tailor the Nonamen® concept for the Chinese market. Following the successful completion of this phase, CDBIO will receive a license to further develop and commercialize the vaccine.

Intravacc’s unique Nonamen® technology offers a broad panel of PorA proteins inserted in so called Outer membrane vesicles (OMV) expected to induce protection against the Meningococcal B (MenB) disease. Furthermore, the Nonamen® technology can be included in a Meningitis combination vaccine.

Under the agreement, both parties will collaborate to establish the development of an efficacious vaccine against prevalent Men B serotypes in China.

“We are very happy to partner with CDBIO and to be able to expand the global reach of our Nonamen technology. We trust this will help to prevent the occurrence of Men B in China considerably”, said Mr Nico Oudendijk, General Director of Intravacc.

 

Intravacc and BCHT enter into license agreement for production of a Hib conjugate vaccine

News | 12-11-2018

Intravacc and BCHT have entered into a non-exclusive license agreement for the development of a Hib conjugate vaccine within the People’s Republic of China.

Intravacc and Changchun BCHT Biotechnology Co today announced that they have entered into a non-exclusive license agreement towards the development ofa Haemophilus influenzae Type B (Hib) Conjugate Vaccine within the People’s Republic of China. By combining their strengths, the two parties can together lower the incidence of this vaccine preventable disease in China.

Through this agreement, BCHT obtained Intravacc’s unique Hib conjugate technology to further develop, produce and sell the vaccine. The vaccine consists of a Hib polysaccharide (poly-ribosylribitol phosphate, PRP) coupled to tetanus toxoid that has shown to be effective in preventing the disease. The Intravacc Hib vaccine technology has already been used for the vaccination of 100s of millions of children.The license agreement between Intravacc and BCHT will now help to reduce the incidence of Hib in Chinese children.

Of the 6 types of H influenzae, type B is responsible for more than 90% of systemic infections. Hib can cause serious illness like acute lower respiratory tract infection and bacterial meningitis. In China, for children under age of 5 years old, the incidence of meningitis caused by Hib was reported in a survey about 10.7/100 000 annually; 9.7% of these cases were fatal, and 21.4% of survivors suffered from neurological or psychological problems. The agreement between Intravacc and BCHT will help to bring this number down considerably.

‘’It’s great to hear that the innovative work of our researchers at Intravacc will contribute to the prevention of Hib in China. We are proud to partner with BCHT to prevent this disease.” said Mr Nico Oudendijk, General Director of Intravacc.

Intravacc and TherapyX partner to develop world’s first prophylactic vaccine against Gonorrhea

News | 15-10-2018

Intravacc has entered into a strategic partnership with TherapyX for the co-development of the world’s first prophylactic vaccine to provide lasting, protective immunity against Neisseria gonorrhoeae.

Intravacc is pleased to announce that it has entered into a strategic partnership with TherapyX for the co-development of NGoXIMTM, the world’s first prophylactic vaccine against infection with Neisseria gonorrhoeae. This new vaccine is intended to enhance specific adaptive immune responses that provide lasting, protective immunity against N. gonorrhoeae. NGoXIMTM is a combination of a sustained-release formulation of interleukin 12 (GneX12TM) and bacterial outer membrane vesicles (OMV) formulated for mucosal delivery.

No effective gonorrhea vaccine is currently available and the disease is known to be acquired repeatedly with apparently no development of protective immunity from previous infection. The American Centers for Disease Control and Prevention (CDC) has listed antibiotic-resistant N. gonorrhoeae as one of the top three pathogens presenting “an immediate public health threat that requires urgent and aggressive action.” A recent WHO technical consultation on vaccines against sexually transmitted infections (2017) called for renewed efforts to develop a vaccine against gonorrhea. This partnership effort is a direct response to that call.

Under the terms of the partnership agreement, TherapyX will focus efforts on IND-enabling efficacy and toxicology studies in primates while Intravacc will be responsible for the discovery and development of OMVs with improved immunogenic properties and reduced toxicity. Financial terms were not disclosed.

“We are thrilled to partner with Intravacc” said Dr. Dominick L. Auci, Vice President for Research and Development at TherapyX. “They bring over 100 years of expertise in vaccines including novel OMV technology to this important project. We couldn’t be working with a more experienced, innovative and dedicated team”.

“We are delighted to be working with TherapyX” said Mr. Nico Oudendijk, General Director of Intravacc. “The IL-12 technology they bring into the project is key to develop an efficacious vaccine against this disease.”

 

Serum Institute of India and Intravacc to develop Bioneedles

News | 04-06-2018

  

New Delhi/Bilthoven, 29th May 2018: Life Sciences and Healthcare is a vital area of collaboration for India and the Netherlands.  Growing market opportunities in India, combined with the Netherlands’ strengths in Healthcare, create excellent opportunities for Indo-Dutch partnerships that address shared societal challenges with smart solutions. One of the key healthcare challenges that are being turned into Indo-Dutch collaborative solutions is vaccine delivery.

Serum Institute of India and Intravacc (part of the Netherlands Ministry of Health, Welfare and Sports) will jointly develop a novel delivery system for vaccines: Bioneedles. The Bioneedle, a tiny biodegradable mini implant, is a unique approach with ground breaking potential to transform vaccination campaigns, especially in low and middle income countries. The parties will develop Bioneedles for vaccines against measles and rubella. The Memorandum of Understanding confirming their collaboration was signed in the presence of Mark Rutte, Prime Minister of the Netherlands, Sigrid Kaag, Dutch Minister for Foreign Trade and Development Cooperation, Bruno Bruins, Dutch Minister for Medical Care and Sports, Hans de Boer, CEO, Confederation of Netherlands Industry and Employers VNO-NCW, and H.E Alphonsus Stoelinga, Ambassador of the Netherlands to India, during the Netherlands Trade Mission to India last week. The signatories were Dr Suresh Jadhav, Executive Director, Serum Institute of India and Thijs Veerman, CEO, Intravacc.

“I am happy that this MoU was signed during The Netherlands Trade mission to India. The collaboration between SII and Intravacc is a good example of a cooperation in which companies from India and The Netherlands join forces to help improve health worldwide,” Bruno Bruins, Minister for Medical Care of The Netherlands was quoted as saying. 

 

Currently, vaccines are mostly administered through intramuscular or subcutaneous injection by needle and syringe. The use of needles however may cause pain and fear in vaccinated people, and  requires trained personnel, which is not always readily available in low and middle income countries.  Moreover, needle waste can be hazardous due to reuse and needle-stick injuries and, as a result, transmission of infectious diseases like hepatitis or HIV. To overcome these issues, numerous alternative vaccine administration devices and methods are currently being developed.

One of the most promising technologies in alternative vaccine delivery is a Bioneedle-based delivery device. “Vaccines play a critical role in public health globally- and for Intravacc, India is a vital market for partnerships in vaccine development. This project could potentially mark a major step towards vastly improved access to vaccines especially in low and middle income countries. We are very happy to be involved in such an innovative project with our Indian partner,” Thijs Veerman, CEO, Intravacc says.

Bioneedles are composed of a starch-like polymer, a product that is naturally degraded by the human body. The Bioneedle is administered by an implantation under the skin with an applicator. The Bioneedle matrix will degrade after implantation, which enables the release of the freeze dried vaccine. This reduces hazardous needle waste and results in a quick and pain-free delivery of the vaccine; it may even abolish the need for trained professionals to perform vaccinations – a huge benefit in developing countries where trained medical personnel is scarce. In addition, vaccines in Bioneedles are both freeze and heat stable and can be stored, transported and distributed outside any cold chain. Preclinical concepts of Bioneedles have been established with numerous vaccines, including tetanus, polio, influenza and hepatitis B. In all cases, Bioneedles filled with vaccine were able to induce potent systemic humoral immune responses against the respective antigen. Serum Institute of India and Intravacc will jointly develop Bioneedles for vaccines against Measles and Rubella. Intravacc will optimize the formulation of the vaccine and preparation of the Bioneedles and freeze drying process; Serum Institute of India will supply the MR vaccine. Both parties will search for a partner, preferably from India, for developing a suitable applicator device to administer the Bioneedles.
 

“We are now the world's largest vaccine manufacturer by number of doses produced. It is estimated that about 65% of the children in the world receive at least one vaccine manufactured by Serum Institute, saving millions of lives throughout the world,” says Dr Suresh Jadhav, Executive Director, Serum Institute of India. With this project we continue to build a sustainable, long-term partnership with Intravacc in our effort to manufacture affordable life-saving vaccines .”

All together this is a unique approach with ground breaking potential to transform vaccination campaigns, especially in the low and middle income countries.

Dutch Ministry of Health announces privatization of Intravacc

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.

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 Selects Intravacc as Product Development and Manufacturing Partner for Coxsackievirus B Vaccine

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).

  • Coxsackievirus B appears to be an important trigger for type 1 diabetes

  • Acute Coxsackievirus B infection and its complications present a serious unmet need in pediatrics

  • L2D Services providing product development, regulatory and project management support

 

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.”

 

About Type 1 Diabetes and Coxsackievirus B Infection

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.

 

About Intravacc

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.

About Provention Bio, Inc.

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.

About Vactech Ltd.

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.

About L2D

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.

 

Forward Looking Statements

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

 

Career

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Career

Onderzoeksmedewerker / chemicus

Close Binnen Intravacc zoeken we voor de afdeling ADF een

Onderzoeksmedewerker / chemicus

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.

Onderzoeksmedewerker / chemicus

36 uur per week

Vacaturenummer INT081

 

Afdeling

De afdeling Analysis, Delivery & Formulation (ADF) wordt gewerkt aan biologische en chemische methoden om vaccins te maken en te karakteriseren.

 

Functie

We zoeken een gedreven persoon die een belangrijke bijdrage kan leveren aan het ontwikkelen van nieuwe vaccins. Je voert werkzaamheden uit op het gebied van conjugaatvaccins waarbij vaccincomponenten zoals peptiden, eiwitten of oligosacchariden worden gekoppeld aan biologische zo wel als synthetische dragers.

 

Jouw kennis en expertise zul je zelfstandig inzetten op het uitvoeren op chemische conjugaties, zuivering en karakterisering van tussen- en eindproducten. Hierbij worden spectroscopische technieken, zoals NMR, UV-Vis en DLS, en chromatografische apparatuur, zoals size-exclusion chromatografie (SEC) en field-flow fractionation (FFF) toegepast om vaccinproducten te karakteriseren. Je voert de activiteiten zelfstandig uit onder begeleiding van een (deel)projectleider.

 

Functie-eisen

  • Afgeronde opleiding (BSc) in de richting van chemie of biochemie
  • Relevante werkervaring van minimaal 1 - 3 jaar
  • Ruime ervaring met het ontwikkelen en uitvoeren van conjugatie reacties (bijv. fluorescente labeling, chemische modificaties van eiwitten en oligosacchariden)
  • Kennis van chemische en biochemische methoden, zoals NMR, chromatografie (HPLC, SEC), DLS en FFF-MALS
  • Kennis van small molecule en polymeersynthese en karakterisering is een pré
  • Flexibele werkhouding en goed in staat om zowel in teamverband als zelfstandig te kunnen werken
  • Goede beheersing van de Nederlandse en Engelse taal in woord en geschrift

 

Keywords

Chemistry, conjugatie, vaccinontwikkeling, synthese, organische chemie, polymeer, MS Office, Graphpad Prism, ChemDraw.

 

Aanbod

Het salaris is, afhankelijk van opleiding en ervaring, maximaal € 3.384,77 (BBRA-schaal 8) op basis van een volledig dienstverband (36-urige werkweek), exclusief 8% vakantietoelage en 8,3% eindejaarsuitkering.

Je wordt aangesteld in tijdelijke dienst voor een periode van 12 maanden.

 

Informatie

Voor meer informatie kun je contact opnemen met dr. B. (Bernard) Metz, afdelingshoofd ADF (T: 030 7920 485) of M. (Maarten) Danial (T: 030 7920 481).

 

Solliciteren

Wij ontvangen je sollicitatie, bij voorkeur digitaal, uiterlijk 28 januari 2019 via personeelszaken@intravacc.nl  

 

Bij Intravacc is een vaccinatiebeleid van toepassing.

 

Download de vacaturetekst

Onderzoeksmedewerker / Analytisch chemicus

Close Intravacc is op zoek naar een

Onderzoeksmedewerker / Analytisch chemicus

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.

Onderzoeksmedewerker / Analytisch chemicus

36 uur per week

Vacaturenummer INT082

Afdeling

Binnen de afdeling Analysis, Delivery & Formulation (ADF) wordt gewerkt aan de ontwikkeling van biologische, immunologische en chemische methoden ter ondersteuning van de vaccinontwikkeling om tussen- en eindproducten te karakteriseren.

 

Functie

Vaccinontwikkelingsprojecten en immunologisch onderzoek zijn in hoge mate afhankelijk van de beschikbaarheid van kwalitatieve en kwantitatieve analysetechnieken zoals massaspectrometrie (MS), veelal gecombineerd met vloeistofchromatografie (LC). Als onderzoeksmedewerker/analytisch chemicus zul je je met deze technieken richten op de identificatie, karakterisering en kwantificering van (antigene) eiwitten. Hiertoe beschikt het laboratorium over een aantal moderne massaspectrometers gekoppeld aan geminiaturiseerde chromatografische systemen.

Je zult primair gaan werken in een klein team dat gespecialiseerd is in MS-gerelateerd proteomics onderzoek. Vanwege het multidisciplinaire karakter van je werkzaamheden, zul je ook nauwe contacten onderhouden met immunologen, microbiologen, procesontwikkelaars en formuleringsexperts.

 

Functie-eisen

  • Afgeronde opleiding (BSc of MSc) in de richting van analytische chemie of biochemie
  • Relevante werkervaring van minimaal 3 jaar met name op het gebied van (Immuno)proteomics gerelateerd LC-MS onderzoek
  • Algemene kennis op het gebied van eiwitten en peptiden en de karakterisering/identificatie hiervan. Immunologische kennis is een pré
  • Nauwgezet en goed in staat om je werkzaamheden volgens de principes van Good Laboratory Practice uit te voeren, zowel in teamverband alsook zelfstandig
  • Flexibele werkhouding
  • Goed kunnen presenteren van onderzoeksresultaten in woord en geschrift in de Nederlandse taal en bij voorkeur ook in de Engelse taal

 

Trefwoorden

(Immuno)Proteomics, System Vaccinology, vloeistofchromatografie, massaspectrometrie

 

Aanbod

Het salaris is, afhankelijk van opleiding en ervaring, maximaal € 3.809,29 (BBRA-schaal 9) op basis van een volledig dienstverband (36-urige werkweek), exclusief 8% vakantietoelage en 8,3% eindejaarsuitkering. Je wordt aangesteld in tijdelijke dienst voor een periode van 12 maanden. Bij goede en volledige functievervulling behoort daarna een vaste aanstelling tot de mogelijkheden.

 

Informatie

Voor meer informatie kun je contact opnemen met dr. B. Metz, afdelingshoofd ADF (T: 030 7920 485) of dr. H.D. Meiring (T: 030 7920 484).

 

Solliciteren

Wij ontvangen je sollicitatie bij voorkeur digitaal via personeelszaken@intravacc.nl.

 

Download de vacaturetekst

Managementassistent

Close Intravacc is op zoek naar een

Managementassistent

Het Instituut voor Translationele Vaccinologie (Intravacc) is dé plek in Nederland met een breed toegankelijke en complete infrastructuur voor translationele vaccinonderzoek en -ontwikkeling. Op het instituut worden goede ideeën uit de wetenschap verder geholpen op het pad naar vaccins die waardevol zijn voor zowel de volksgezondheid als het bedrijfsleven. Het instituut rekent zowel de (inter)nationale overheden als diverse farmaceutische en biotech bedrijven tot haar klanten. In het komend jaar zal het instituut worden verzelfstandigd tot een publiek-private onderneming.

Managementassistent m/v

(32 uur per week)

 

Vacaturenummer: INT079

 

Functieomschrijving

In de functie van Managementassistent ben je primair verantwoordelijk voor de secretariële ondersteuning van het managementteam (MT) van Intravacc. De organisatie is volop in ontwikkeling door de verzelfstandiging, waardoor er in sommige gevallen snel geanticipeerd moet worden.

 

Je zorgt dat de MT-leden hun werk goed kunnen uitvoeren, zonder zich druk te hoeven maken over randzaken. Je ondersteunt en adviseert het MT gevraagd en ongevraagd op tactisch en operationeel niveau. Je begrijpt waar de prioriteiten van het MT liggen, en beheert en bewaakt op basis daarvan de druk bezette agenda's.

 

Je bereidt de agenda van het MT-overleg voor, beoordeelt aangeleverde stukken op helderheid en compleetheid en notuleert de vergadering. Daarnaast faciliteer je de communicatie met de interne organisatie over de genomen MT-besluiten.

 

Ook verricht je algemene secretariële en administratieve werkzaamheden, zoals het boeken van reizen en aanvragen van visa. Tevens ben je het aanspreekpunt voor de medewerkers van Intravacc en zorg je voor informatieverstrekking, organisatorische werkzaamheden en facilitaire dienstverlening. Hierbij wordt voornamelijk gewerkt met Outlook, SAP, Skype voor Business en Sharepoint. Samen met een collega vorm je het secretariaat van Intravacc.

 

Functie-eisen

Je bent een ervaren, proactieve en accurate Managementassistent. Je denkt vooruit, neemt zelfstandig actie en draagt hierdoor zorg dat de leidinggevenden ontzorgd worden. Je bent gewend aan een hoog tempo en kunt snel schakelen. Je bent organisatorisch sterk en kunt inspelen op ad hoc zaken. Je neemt initiatief waar mogelijk, en handelt tal van zaken zelfstandig af.

 

Je kunt goed in teamverband werken, bent integer en brengt professionaliteit, openheid en samenwerkingsgerichtheid in. Ook ben je klantgericht, organisatiesensitief, ondernemend en werk je nauwkeurig.

 

Tevens beschik je over uitstekende kennis van de Nederlandse en de Engelse taal in woord en geschrift. Je bent het gewend om te notuleren en dit gaat je gemakkelijk af.

 

Gevorderde kennis van kantoorapplicaties en –programma’s (Outlook, Excel, Word, Power Point). Kennis van SAP, Skype voor Business en Sharepoint is een pré.

 

Arbeidsvoorwaarden

Het salaris is, afhankelijk van opleiding en ervaring, maximaal € 3.013,89 bruto per maand (BBRA-schaal 7). Het salaris is gebaseerd op een volledig dienstverband (36-urige werkweek), exclusief 8% vakantietoelage en 8,3% eindejaarsuitkering.

 

Het betreft een tijdelijke aanstelling voor de duur van 1 jaar. Bij gebleken geschiktheid zal de tijdelijke aanstelling worden omgezet in een aanstelling voor onbepaalde tijd.

 

Aangezien Intravacc aan de vooravond van verzelfstandiging staat en het MT nog niet op volle sterkte is, kan de functie van Managementassistent als groeifunctie worden gezien. Dat wil zeggen dat mogelijk na verzelfstandiging – bij goede en volledige functievervulling – opnieuw naar het takenpakket en het daarbij behorende salarisniveau van de functie gekeken wordt.

 

Informatie

Voor meer informatie over de functie kun je terecht bij Daniëlle Lankveld, Chief Operating Officer, 030-7920476.

 

Solliciteren

Je sollicitatie kun je sturen naar personeelszaken@intravacc.nl

 

Download de vacaturetekst

 

Wetenschappelijk medewerker / (Bio) Procestechnoloog DSP

Close De afdeling Process Development Bacterial Vaccines (PDBV) zoekt een

Wetenschappelijk medewerker / (Bio) Procestechnoloog DSP

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.

Wetenschappelijk medewerker / (Bio) Procestechnoloog DSP

36 uur per week

Vacaturenummer: INT071

 

De afdeling

Binnen de afdeling PDBV worden processen ontwikkeld voor de productie van bacteriële vaccins. Voorbeelden hiervan zijn buitenmembraan blaasjes (OMV)- en polysacharide-conjugaatvaccins tegen verschillende pathogene micro-organismen. Bij de procesontwikkeling op labschaal wordt het kweken van bacteriën (USP) en de productisolatie en -zuivering (DSP) onderzocht en geoptimaliseerd. Na eventuele procesopschaling worden de vaccins onder GMP condities geproduceerd voor klinisch onderzoek. Binnen de afdeling wordt gewerkt met state-of-the-art apparatuur en samen met leveranciers worden innovatieve technologieën ontwikkeld en getest.  

 

De functie

Voor de afdeling PDBV zijn we op zoek naar een ervaren wetenschapper DSP. We zoeken een gedreven persoon met ervaring op het gebied van filtratie (TFF), kolomchromatografie en andere scheidingstechnieken voor biologicals alsmede karakterisatie van deze producten

Je hebt als taak het DSP proces van bacteriële vaccinontwikkelingsprojecten te ontwerpen en te optimaliseren op verschillende schalen (bench-tot pilot schaal). Naast het onderzoek lever je een bijdrage aan de bereiding van de vaccins onder GMP-condities voor klinisch onderzoek. Je bent in staat het team te helpen bij problemen en je bent een sparringpartner voor de DSP groep.

Naast de inhoudelijke taken kunnen het functioneel aansturen van een team als (deel)projectleider en het leveren van een inhoudelijke bijdrage bij de acquisitie van nieuwe projecten tot de taken behoren.

 

Het profiel

  • Je bent een gepromoveerd bioprocestechnoloog of biotechnoloog met minimaal 3 jaar ervaring met downstream processing
  • Je hebt minimaal 3 jaar ervaring op het gebied van de procesontwikkeling van bacteriële vaccins of vergelijkbare producten
  • Je hebt kennis van complexe biologicals bijv. OMVs, VLP of recombinant eiwitten.
  • Je hebt kennis van procesontwikkeling volgens Quality by Design, Process Analytical Technology en/of Design of Experiments
  • Ervaring met het leiden van projecten en kennis van GMP is een pre
  • Je beschikt over overtuigingskracht en bent initiatiefrijk, efficiënt en kwaliteitsbewust
  • Je deelt kennis, informatie en ideeën en stimuleert wetenschappelijke discussies
  • Je bent een teamspeler
  • Je hebt uitstekende communicatieve vaardigheden en de vaardigheid om met zowel externe klanten als multidisciplinaire projectteams binnen de eigen organisatie te communiceren
  • Je hebt een goede mondelinge en schriftelijke beheersing van de (Nederlandse en) Engelse taal  

 

Ons aanbod

Het salaris is, afhankelijk van opleiding en ervaring, maximaal € 5.450,88 bruto per maand (BBRA-schaal 12). Het salaris is gebaseerd op een volledig dienstverband (36-urige werkweek), exclusief 8% vakantietoelage en 8,3% eindejaarsuitkering.

Je wordt geplaatst binnen de afdeling Process Development Bacterial Vaccines en aangesteld als Wetenschappelijk Medewerker volgens de indeling in het Functiegebouw Rijk.

De aanstelling is in eerste instantie tijdelijk voor de duur van 1 jaar, met uitzicht op verlenging.

 

Informatie

Voor meer informatie over de functie kun je terecht bij dr. Michiel Stork, Afdelingshoofd Process Development Bacterial Vaccines, telefoon: 030-7920 525.

 

Solliciteren

Je sollicitatie kun je  sturen naar personeelszaken@Intravacc.nl.

 

Download de vacaturetekst

Scientist (Bio)Process technology DSP

Close The department of Process Development for Bacterial Vaccines (PDBV) is looking for

Scientist (Bio)Process technology DSP

Intravacc is an applied scientific research institute that develops new vaccines. At Intravacc new promising ideas are carried further down the path to mature into vaccine product that are valuable for public health and industry. Next to this, Intravacc uses its vast knowledge on vaccine development in R&D project for our customers. Our customers are amongst others (international) governments and companies in the innovative pharmaceutical industry. Intravacc will be privatized in the coming year.

Scientist (Bio)Process technology DSP

36 hrs per week

Vacancy number: INT071

 

The department

The group focusses on the development of production processes for bacterial vaccines. The main areas of research are on outer membrane vesicles (OMV) and polysaccharide conjugate vaccines against different pathogenic microorganisms. During the process development at bench scale, the cultivation (USP) and the purification (DSP) is investigated and optimized. After upscaling, the experimental vaccines are produced under cGMP to be tested in clinical studies. The department has state of the art equipment and together with our suppliers we develop innovative technologies to be tested in our processes.

 

The position

We are looking for a scientist downstream processing who has experience with filtration, column chromatography and other separation and purification techniques for biologicals. As scientist DSP your tasks include the design and optimization of bacterial vaccine development at bench and pilot scale. With your input you have a great degree of influence on the design of the processes. Besides this you will contribute to the cGMP activities. You are a team player and are capable to solve complex topics.

Guiding a small research team and/or project leading activities can be part of the position.

 

The profile

  • You have a Ph.D. degree in bioprocess technology or biotechnology with at least 3 years working experience in downstream processing
  • You have at least 3 years experience in process development of bacterial vaccines or similar products.
  • You have knowledge of complex biologicals like OMVs and VLPs or recombinant proteins.
  • You have knowledge of Quality by Design, Process Analytical Technology and/or Design of Experiments
  • Experience with leading projects and with GMP is preferred.
  • You are pro-active and have a scientific drive to broaden the expertise
  • You are a team player
  • You have good communication skills in (Dutch and) English.

 

Our offer 

It is a long term position with initial employment for 1 year.

 

Information

For more information about this job offer you can contact Dr. Michiel Stork, Department head Process Development Bacterial Vaccines, phone number: 030-7920 525.

You will be placed within the department for Process Development Bacterial Vaccines as a scientist according to “Functiegebouw Rijk”.

The stipend is based on education and experience with a maximum of € 5.450,88 per month (BBRA-schaal 12) before taxes. The stipend is based on 36 hours per week excluding holiday pay (8%) and end of year pay (8.3%).

 

How to apply

You can send your motivation letter and CV to personeelszaken@Intravacc.nl .

 

Download vacancy text

 

Visiting address | Antonie van Leeuwenhoeklaan 9 | 3721 MA | Bilthoven | The Netherlands
Postal Address | P.O. Box 450 | 3720 AL | Bilthoven | The Netherlands
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