Lonza ‘scaling up’ Moderna's promising Covid-19 vaccine process

Lonza believes that the first commercial volumes of the ingredients for the Moderna vaccine will be available by the end of December. Keystone / Dominic Steinmann

Swiss company Lonza has signed a major deal with US biotech Moderna Therapeutics to help produce a promising Covid-19 vaccine using new mRNA technology. Lonza CEO Albert Baehny says the firm can rise to the challenge of producing hundreds of millions of doses starting this year, if trials continue to prove successful.

This content was published on May 20, 2020 - 08:26

On Monday, Modern Therapeutics released results of the phase one trials of its mRNA vaccine – the first of its kind – in humans. They are giving Baehny reason to be optimistic, albeit cautiously.

“The results are excellent. We understand the technology and the manufacturing process. We now hope that phases two and three go well,” he says.

The were limited with only a small number of participants and some vaccine experts interviewed by health news site STATnewsExternal link say that based on the information available it is difficult to know how impressive the results are. But the vaccine did generate some immune response.

A biologist by training, Albert M. Baehny became Chairman of the Board of Lonza in 2018. Baehny took over as CEO on an ad interim basis after former Lonza CEO Marc Funk left the company at the end of 2019. Lonza

That’s good news for both Moderna and Lonza, since the established Swiss pharma and chemicals company signed a 10-year dealExternal link with the US biotech firm to help manufacture the new mRNA vaccine technology. Lonza answers a key question hovering over the smaller Moderna, which is how to produce enough vaccine to meet global demand, if the therapy proves effective.

Lonza chairman and ad interim CEO Baehny spoke with about what the deal with Moderna means and what it will take to bring the vaccine to the masses.

SWI What does Lonza bring to the deal with Moderna?

Albert Baehny (AB): We bring three things that are important and that is firstly, a broad range of manufacturing processes. We also have expertise in bringing lab processes to commercial, industrial scale processes and lastly, we offer Moderna access to manufacturing facilities in many different locations.

It is important to clarify that we will be producing the Active Pharmaceutical Ingredients (API) for the vaccine. We are not producing the final vaccine as some have reported.

When we will have produced the API, this will go to another company that will do the fill and finish, which means they will fill the final vaccine into vials.

SWI: Which company will produce the final vaccine?

AB: That remains confidential.

SWI: How are you preparing your manufacturing facilities for the vaccine?

AB: We are in the process of scaling up Moderna’s lab process into an industrial process. This is happening in Portsmouth, New Hampshire in the United States, which will be the first site where we are producing the ingredients.

In parallel, we are also starting a manufacturing line in Visp, Switzerland.

SWI: What is your timeline?

AB: From the Portsmouth facility, we expect to have a small batch for clinical use by July. The first batch of commercial volumes will be available by the end of December.

We anticipate that we will be able to produce the first volumes from the Visp facility by February 2021.

SWI: There have been a lot of questions about who will receive the first doses of the vaccine. Who ultimately owns the vaccine and can decide?

AB: We don’t own the vaccine. Moderna owns the intellectual property and we own the technology to manufacture the API. There is a whole supply chain as well.

What is an mRNA vaccine?

Messenger RNA (mRNA) vaccines work by introducing an mRNA sequence (the molecule which carries genetic code from DNA) which is coded for a disease specific antigen. Once produced within the body, the antigen is recognised by the immune system, enabling it to fight the disease.

This contrasts with conventional vaccines, which typically contain inactivated disease-causing organisms or proteins made by the antigens, which work by mimicking the infectious agent and stimulate the body’s immune response.

On May 12, the US Food and Drug Administration granted Fast Track designation to Moderna’s Covid-19 vaccine candidate that is based on mRNA technology. Following the phase 1 trial, the company has received the green light to go ahead with phase 2.

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SWI: How many doses can Lonza produce?

AB: There are expected to be many manufacturing lines. We estimate that one line will be able to produce 50-100 million doses a year but this depends on the final dosage, which we won’t know until the end of phase three clinical trials.  

The Visp facility could have as many as three manufacturing lines running in parallel, which would mean 100-300 million doses could be produced there.

SWI: What makes the mRNA vaccine production process different from traditional vaccines?

AB: If the vaccine proves effective, it will be the first time a vaccine is based on mRNA technology. This technology is easier and faster to produce and develop than other technology to produce vaccines such as using a dead virus or bacteria.

It is also cheaper to produce because the manufacturing footprint is smaller than at a biologics plant. That is why the race for a vaccine against Covid-19 is moving in the direction of mRNA.

SWI: What are some of the challenges of producing such a vaccine? Are there specific safety concerns?

AB: The manufacturing process is safe. The safety question is really that everything, such as the authorisation processes, is being accelerated because there is a need to help society and help us get back to a normal life. The regulatory authorities will authorise the vaccine when the benefits outweigh risks.

+ Swiss vaccine approval: as fast as possible, as slow as necessary

The main challenge for Lonza is the access to equipment. It is like the parts of a car. We are buying manufacturing parts externally so access to them is essential. This equipment comes from everywhere.

We also need people to work at the facilities. Once we have a line up and running, it will take another 60-70 people to operate it.

This is a view of the Lonza site in the town of Visp in canton Valais. Visp is the founding location for the company and an important manufacturing site for Active Pharmaceutical Ingredients. Lonza

SWI: How much will the vaccine cost?

AB: We are investing some CHF60-70 million ($61.7 million – $72 million) to produce 50-100 million doses. We don’t know the price of the final dose.

SWI: What does this deal mean for Lonza as an organisation?

AB: It is motivating for the whole organisation to be serving society. It is an ethical and moral responsibility and we are investing without knowing if it will work. The purpose is first and foremost to save lives. That is more important than the commercial success, which comes afterwards.

SWI: Isn’t this a risky venture?

AB: Even if the vaccine doesn’t work, we still have ten years of collaboration with Moderna to bring other mRNA medicines to market. There are really no risks. With a ten-year deal, we can only benefit because this gives us access to mRNA, which is a new technology. If it doesn’t work, there will be other opportunities.

SWI: How important is Swiss innovation in the development of the vaccine?

AB: It is Swiss technology and know-how that is being transferred to North America and maybe Singapore. We see Switzerland’s innovation capacity as playing an important part of this transformative process. Teams are highly motivated because they realise they are writing a bit of history.

Lonza: history and operations

Founded in 1897 as an electricity producer and then a fertilizer manufacturer, Lonza now works as the contract manufacturing arm for many large pharmaceutical companies. It operates manufacturing sites around the world, including in the southern Swiss canton of Valais where it was founded. It is headquartered in Basel and in Morristown, New Jersey in the US.

The company has more than 15,500 employees and operates 120 sites and offices in more than 35 different countries. 

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If the mRNA vaccine proves effective, Swiss manufacturing of it will happen at the company's new Ibex solutions facility that is expected to be operational in the beginning of 2021. Lonza

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