Marburg, Germany (AP) — Germany is pondering how to accelerate its subsequent sluggish coronavirus vaccination campaign Yet another issue involving AstraZeneca shotsMarburg’s historic pharmaceutical center production facility may retain some of the answers to a reliable supply months and years ahead.
BioNTech, the German company that developed the first widely used vaccine in collaboration with US partner Pfizer, is busy launching a production facility that can produce up to 1 billion doses this year alone. That estimate has been raised from the initial expectations of 700 million.
The company, which had never brought medicines to market, surprised the world last year when it was licensed to sell a whole new type of vaccine in the UK, US and Europe. This is three tightly regulated markets for medical products.
The active ingredient in Shot is messenger RNA, or mRNA, which contains instructions for human cells to build a harmless portion of the coronavirus called the spike protein. The human immune system recognizes peplomer as a foreign body and allows it to initiate a response to the virus upon infection.
Scientists have known for some time how to make mRNA, but not for commercial mass production.
“This is so large and inspiring to do it in such a short period of time, not only from a scientific point of view, but also from a manufacturing point of view,” said Valeska Skilling, the factory’s production manager. Says.
BioNTech was only approved by the European Medicines Agency on Friday for vaccine production at the Marburg site purchased from Novartis last year. The site is part of a cluster in the pharmaceutical industry that dates back more than a century to Nobel laureate Emil von Behring, who developed diphtheria and tetanus antitoxins.
Globally, BioNTech and Pfizer currently estimate that they will be able to produce 2.5 billion doses in 2021, 500 million more than February’s forecast.
To achieve that, about 400 employees face the challenges of large-scale production, including about 50,000 individual steps, some of which require months of training. A serious concern in the handling of mRNA, which is notorious for its fragility, is the strict avoidance of external contamination. Workers with a degree in areas such as biology or pharmacies usually need to wear two protective suits, boots, and a full head cover, which takes 20 minutes to wear.
Last week, the company introduced journalists to several manufacturing equipment, including bioreactors, metal drums where mRNA is produced from raw materials sourced from tubes and carefully monitored. One batch can contain enough mRNA to administer 8 million doses in a bag that is not much larger than a large bag of rice. It is then filtered and combined with lipid or fat molecules to encapsulate the mRNA and form small particles that protect it after injection into the human body. The final step is filling the vial performed by an external partner.
The German government has been hit hard domestically for entrusting the European Union to procure vaccines, resulting in far more restricted supplies than the United Kingdom and the United States.With safety Supply trouble with another vaccineCreated by AstraZeneca, a British and Swedish company, further emphasizes how dependent the EU is on off-block research and manufacturing.
Suffering from criticism and conscious of Germany’s next national election, Berlin cast its weight behind the Marburg plant and helped drive the necessary paperwork through the German bureaucracy.
The government’s vaccine-producing emperor, Christoph Krupp, said the company is increasing its capacity, buying new equipment and hiring more staff. Meanwhile, the government is trying to reassure them that their investment is not wasted.
“We don’t know how the pandemic is progressing, so we want to be prepared to maintain the production structure we are building in the medium term,” Krupp said. “I don’t know how the virus mutates … I don’t know if another pandemic will occur.”
In a daily interview with Frankfurter Allgemeinezeitung, Krupp needed some state assistance, and the government considered 500 million quarterly vaccine production reserves, or about 2 billion annually. Said that.
In practice, this means that another one or two plants, such as those in Marburg, will be needed in the European Union. These may prioritize block orders, but there is no complete export ban on vaccines from the EU and other regions may also benefit.
The government may want the investment to be rewarded. According to economists quoted by the Ifo Institute for Economic Research in Germany, short-term availability of vaccines could result in a net profit of up to $ 1,750 per German per year.
Jordan reported from Berlin.