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No vaccine exists to help doctors in African countries such as Sierra Leone in the struggle against EbolaStage Image

No vaccine exists to help doctors in African countries such as Sierra Leone in the struggle against Ebola

© Getty Images

Ebola epidemic

Researchers seek vaccine to beat Ebola

2016/3/16

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Ebola is an insidious and unpredictable virus. According to the World Health Organization (WHO), the last serious Ebola epidemic, which began in March 2014 and subsided in autumn 2015, caused 11,313 deaths — the highest death rate ever recorded for an Ebola outbreak. This shocking fact has accelerated researchers’ efforts to find a vaccine. Merck KGaA, Darmstadt, Germany, a highly specialized supplier of products for biotechnological research, is playing a major role in these efforts.

In the mid-1970s, 602 people living along the Ebola River in the Democratic Republic of Congo and in neighboring Sudan fell ill with a high fever and internal bleeding. Almost three quarters of these people died, because at that time there were no medicines or vaccines against this as yet unknown pathogen. In the following 40 years, 33 Ebola outbreaks took a total of 1,726 lives. But even in 2014, when a new epidemic broke out, doctors in West Africa were still no better armed to fight the virus than they had been before. Since the first outbreak there had been several attempts to develop a vaccine, but none had made it to market launch.
  • Professor Carlos Guzmán from the Helmholtz Centre for Infection Research
  • Professor Carlos Guzmán from the Helmholtz Centre for Infection Research
    © HZI

    Professor Carlos Guzmán from the Helmholtz Centre for Infection Research in Braunschweig, Germany explains that there are several reasons for this, “In the 1970s we were dealing with a highly infectious pathogen that had infected comparatively few people, in absolute terms, in a rural region of Africa that was difficult to access. Isolation measures kept the Ebola epidemic in check. The long and expensive process of developing a vaccine was therefore not pursued at that time.”

    Development of an Ebola vaccine picks up speed


    Various strains of the Ebola virus had always been latent in West Africa as well, but the outbreak in 2014 dramatically changed the situation in several West African countries. The number of cases grew rapidly. The virus reached the cities and crossed borders to neighboring countries. Every day there were new reports about the latest drastic increases in the number of people infected. Ebola suddenly had the potential to become a global threat. A vaccine had to be developed as soon as possible. At this point the Ebola research that had been continuing behind the scenes in previous decades began to pay off. And that’s why, according to WHO, four potential vaccines are already undergoing clinical studies today. This is a record time for a process that can normally take up to 12 years, as Professor Guzmán points out.

  • Novavax is working to develop a vaccine for the Ebola virus using two products from Merck KGaA, Darmstadt, GermanyEnlarge
  • Novavax is working to develop a vaccine for the Ebola virus using two products from Merck KGaA, Darmstadt, Germany
    © Getty Images

    Another aspect also plays a role. “The companies have set themselves a fast pace,” reports Rolf Hömke from the Association of Research-Based Pharmaceutical Companies. “If the epidemic peters out before enough participants have been involved in the studies, the companies won’t be able to collect enough data for the applications for approval.” In other words, time is running out. “In the development phase, you can only gain time through forward-looking, smooth organization. For the clinical studies themselves, everything has been precisely specified,” Hömke adds.

    Partners for facing global competition


    In the fall of 2014, Novavax, Inc., headquartered in Gaithersburg, Maryland (USA), was also ready to go. The timeframe was extremely ambitious: Within just three months, it aimed to develop and produce a vaccine and have it authorized for Phase I studies. Under these conditions every day counts, and so does every effort to accelerate the work processes. It’s also important to have partners who can assist you quickly and expertly by providing innovative laboratory solutions and professional know-how — partners like the experts from Merck KGaA, Darmstadt, Germany.
  • During the vaccine production process, proteins are purified using the Chromabolt® chromatography column
  • During the vaccine production process, proteins are purified using the Chromabolt® chromatography column
    © Merck KGaA, Darmstadt, Germany

    At Novavax, vaccines are produced by taking insect viruses that are not dangerous for human beings and using genetic engineering to provide them with a surface marker of the Ebola virus, called EBOV GP (Ebola virus glycoprotein). After the insect cells have been infected, they are lysed and solubilized proteins are extracted. Then a series of purification steps follows, with the EBOV GP nanoparticle vaccine as a result. The Chromabolt® prepacked column from Merck KGaA, Darmstadt, Germany, which is used for protein purification, played an important role in the development of this process.

    Innovative equipment and five weeks gained


    Chromabolt® is a chromatography column that can free up time and resources by as much as 85% for the user after it has been adapted to the process workflow. The column used in the Ebola process has a diameter of 32 centimeters and a fixed bed height of 20 centimeters. It is delivered to customers in a ready-to-use format. The column works as follows: It is filled with a special resin called Fractogel®. If the protein solution is made to run through this resin, various proteins adhere to the resin at different places, depending on their structure. This is how they are separated. Packing such a column can normally take four to six hours, depending on the equipment and other factors.

    “We delivered the ready-to-use column within just three weeks!“

    Ling Bei
    Merck KGaA, Darmstadt, Germany

    If the column does not pass the packing quality control, a repack must be carried out, which requires additional time and labor. Using a prepacked column can significantly speed up this process. This is valuable time, but for Novavax even this pace was not fast enough. “Novavax needed the prepacked Chromabolt® column within three weeks,” says Ling Bei, Sales Development Specialist, who was responsible for smooth communication during this tightly scheduled process. “Normally it takes between six and eight weeks for these columns to be delivered, including all the preliminary checks — but we were able to pull it off in just three weeks!”
  • Dr. Ling Bei is a sales development specialist at Merck KGaA, Darmstadt, Germany
  • Dr. Ling Bei is a sales development specialist at Merck KGaA, Darmstadt, Germany
    © Merck KGaA, Darmstadt, Germany

    2016/3/16

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    The five weeks that Novavax was able to shave off the time for developing its Ebola vaccine played a big role in the company’s success. The Phase I study of the vaccine was conducted in Australia as early as February 2015. In the February 10, 2015 issue of BioProcessing Journal, Timothy Hahn, Senior Vice President for Global Manufacturing Operations at Novavax, described the development of the vaccine and praised everyone who had contributed to this success: “We also wish to thank Merck KGaA, Darmstadt, Germany, for its rapid response and its timely delivery of a prepacked chromatography column.”
     
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