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Ziccum AB (publ) releases Q2 Report 2021

(Lund, Sweden, 26 August 2021) Ziccum AB today releases its Q2 Report for 2021. For the first time the Report will also be released in a digital online format allowing subscribers and readers to more easily interact with and navigate every aspect of the Report.

Read the Q2 Report in its new digital format here: https://reports.ziccum.com/delarsrapport-q2-2021/start/

The PDF of the Report is attached to this Press Release, and is available on the company’s website on: https://ziccum.com/investors/financial-reports/

Ziccum Q2 2021

ZICCUM AB: Andreas Pettersson, Senior Director of Corporate Finance at Northvolt, on being Ziccum’s new Board member

As Senior Director of Corporate Finance at Northvolt AB, a leading innovator in sustainable lithium ion battery production, Andreas Pettersson, Ziccum’s new Board member, is no stranger to disruptive technologies: “Disruption always meet resistance at first, but no incumbent is bigger than history – or global megatrends. Right now, we’re seeing serious and substantial investment in technologies that can genuinely drive sustainable development.”

What first drew you to Ziccum?
I thought Ziccum was an attractive equity story. It has a strong societal mission – backed up by proven, powerful megatrends. From the IMF to the WTO to the World Bank and more – we’re seeing enormous urgency and willingness to invest in solving the global vaccine supply problem now, in both developing and developed countries. Given the amount of vaccine wastage the current Cold Chain contributes to, and the strong likelihood of further pandemics, governments, developments banks, NGOs and INGOs are all re-examining today’s vaccine supply chains – and whether they are really fit for purpose. I believe thermostable vaccines will, and must, happen. The need for a solution to global vaccine supply is immense – the current supply structures alone don’t seem able to fully meet the need.

What convinces you that LaminarPace can be the solution?
LaminarPace’s ambient air-drying technique is a proven, well-functioning technology that can be scaled. And when it comes to scaling execution is key especially when you’re developing a disruptive technology as you will face resistance. So, you need the right team with the right drive and values. The Ziccum team is passionate and determined.

Do you recognize similarities between Ziccum and Northvolt?
Yes, there are some clear resemblances! Even before Covid19 the WHO estimated that up to 50% of vaccines were wasted globally every year because of temperature control and supply chain issues, which simply isn’t acceptable or sustainable. So firstly there is the scale and urgency of the societal problem. I also see growing regulatory and governmental interest in solving the problem, as with Northvolt. There’s the fact that Ziccum is a disruptive technology in a marketplace largely controlled by a few incumbent OEMs – so materially impacting the supply chain and with that the profit pool in the value chain will meet resistance. But again, we come back to the scale of the need and megatrends. New models are needed and will be adopted.

Right now, the technology change in the supply chains and Ziccum are in an early phase, but as awareness develops you could see a rapid acceleration, like you are seeing in the electrical vehicle space for Northvolt. Only a few years ago the electrification of the car industry was an early interesting idea, but then as the snowball kept rolling and market adoption accelerated, everyone now agrees that this is happening and the car manufactures, regulators and investors are putting significant resources into being at the forefront of that development. With disruptive technologies you can reach a tipping point quite suddenly, when things start moving really fast. The question is – when will it come?

Like Ziccum, Northvolt stresses the role its technology can play in reaching the UN’s Sustainable Development Goals (SDGs). Do you think the market see SDGs differently now?
Absolutely. Even five years ago SDGs were tucked away on the back pages of an Annual Report as part of a small CSR section but now it is a very critical part of many companies’ DNA. That’s an enormous change. I know it’s the same with Ziccum. We also find doors opening to us exactly because sustainability is such a core value for us. Right now the market is being really proactive, and actively looking for technologies that can genuinely drive sustainability and sustainable development, and we know vaccines and vaccine access are key metrics in sustainable development – so here too Ziccum’s offering has great potential.

What will your particular skillset contribute to Ziccum?
Through my four years at Goldman Sachs in London and nine years at EQT in Stockholm in the buyout industry, I think I can add a lot from an investor perspective I also think I can bring a broad palette of commercial, strategic and investment perspectives and can help the company focus on the right things. Right now, I’m really looking forward to working closer to the Ziccum team on this journey.

ZICCUM AB: Andreas Pettersson, Senior Director of Corporate Finance at Northvolt, on being Ziccum's new Board member

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ZICCUM AB welcomes urgent calls to ramp up vaccine manufacturing across the globe to address inequity in vaccine access and prevent future pandemics

Last week saw repeated calls from influential global stakeholders to establish or upgrade vaccine manufacturing facilities, particularly those in low- and middle- income countries (LMICs). Ziccum CEO: “We welcome these important developments and share the commitment to scale up vaccine manufacturing and improve Fill and Finish capacity globally. These urgent calls, from multiple groups, show that increasing regional vaccine manufacture is now a question of when, not if. Let’s act now – together.”

Major announcements and reports emphasizing regional manufacture:

The Coalition for Epidemic Preparedness Innovations (CEPI) announced the formation of the COVAX Manufacturing Task Force – an initiative that will be spearheaded by the co-leads of COVAX to urgently address the shortages in vaccine production through improvements in vaccine manufacturing infrastructure.
The Independent Panel for Pandemic Preparedness and Response presented a report that called for urgent action to prevent future pandemics, boosting vaccine production takes time so enabling it must begin now.
The Partnership for Evidence-Based COVID-19 Response (PERC) published a report on the COVID-19 response in Africa, highlighting the urgent need to facilitate local vaccine manufacturing in the African region.

The COVAX Manufacturing Task Force, announced by CEPI has laid out a 3-stage plan to enhance existing vaccine production capacity, as well as expanding long-term production. The Task Force aims to address immediate manufacturing bottlenecks by increasing existing capacity and overcoming workforce limitations, through identifying and matching “Fill and Finish” manufacturers with producers of active ingredients, accelerating approvals of exports permits/ customs clearances and facilitating partnerships for supply of vital vaccine inputs. The long-term goal in Dr Seth Berkley’s (CEO at Gavi, the Vaccine Alliance) vision is for COVAX to expand local production capacity through novel efforts, such as a mRNA vaccine technology, particularly in LMICs.

The need to improve vaccine manufacturing capacity in LMICs is strongly echoed in the recent reports “COVID-19: Make it the Last Pandemic”, published by the Independent Panel for Pandemic Preparedness and Response and “Responding to COVID-19 In Africa” released by PERC, which further cemented the urgency required from the global community to increase vaccine production and share technological expertise to facilitate local vaccine manufacturing, particularly in Africa, and other LMICs.

Ziccum is looking forward to engaging with the global community on these critical matters. In particular, it is essential that all the capabilities of the global vaccine community are leveraged —from vaccine R&D stakeholders through to those working in the clinical development, manufacturing, and regulatory sectors—to address short-term, medium-term, and long-term COVID-19 vaccine manufacturing challenges and bottlenecks.
To address the repeated calls for increased local vaccine production, Ziccum offers its novel ambient air-drying method.

Ziccum is currently planning to develop a series of aseptic modular Fill and Finish plants enabling individual countries to produce up to 30 million vials of thermostable dry-powder vaccines using Ziccum’s patented LaminarPace air-drying technology. This would equate to 300 million doses. Ziccum’s Fill and Finish plants will drive self-sufficiency and security of vaccine supplies across the globe to enable countries to better respond to COVID-19, prepare for inevitable future pandemics and continue routine immunization.

Ziccum CEO Göran Conradson: “We’re pleased to see this strong consensus emerging around the need for increased regional manufacturing of vaccines. As WHO Director General Dr Tedros recently said “the pandemic won’t be over anywhere until it’s over everywhere”.

“We need to manufacture more vaccines where they are needed most – formulated in the best possible way for that region. And we have the technology to do that! When a continent the size of Africa still has to rely on imports for 99% of its vaccine supply – even in the grip of a global pandemic – then we know the system needs improving. And pandemics are speeding up. The next may be right around the corner. The clock is ticking. Now is the time for innovation in vaccine formulation. We need to set vaccines free so that everyone can access, manufacture and formulate them in the best possible way for their people. There’s no time to waste. It’s time to work together.”

Links:

COVAX Manufacturing Task Force – More information available here [https://cepi.net/news_cepi/covax-manufacturing-task-force/]

The Independent Panel for Pandemic Preparedness and Response – “Covd-19: Make it the last Pandemic” [https://theindependentpanel.org/wp-content/uploads/2021/05/COVID-19-Make-it-the-Last-Pandemic_final.pdf]

Partnerships for Evidence-Based Response to COVID-19 (PERC) – “Responding to COVID-19 in Africa” [https://preventepidemics.org/wp-content/uploads/2021/05/PERC-Finding-the-Balance-Part-III-12-May-2021.pdf]

ZICCUM AB welcomes urgent calls to ramp up vaccine manufacturing across the globe to address inequity in vaccine access and prevent future pandemics

Ziccum AB: ‘Thermostable dry powder vaccines can play a key role in six UN Sustainable Development Goals’ – CFO

Ziccum AB is now integrating the UN’s Sustainable Development Goals (SDGs) into every aspect of its industrial and business strategy. CFO Frida Hjelmberg: “We have identified that our regional Fill and Finish plants formulating thermostable dry powder vaccines needing no Cold Chain could be a major engine for six key SDGs. The cost of rolling out such a new approach might seem high–but with the global economy standing to lose up to 9.2 trillion USD if we fail to ensure access to COVID-19 vaccines for LMI (low and middle income) economies, this makes great financial sense.”

“We have now placed sustainability at the heart of our strategic, business and operational focus” says Ziccum CFO Frida Hjelmberg. “Our commitment covers everything from our fast-moving product development work as we develop LaminarPace for industrial scale-up and GMP certification from the EMA – to the strategic collaborations we are working to progress with the UN, UNICEF, WHO, CEPI and more. We agree with GAVI that increased immunization is important in helping achieve almost all 17 of the UN’s Sustainable Development Goals, and we have identified six SDGs in particular that we believe our technology can play a significant role in.”

Breaking the vicious Cold Chain cycle

Ziccum aims to develop a series of Fill and Finish vaccine formulation plants worldwide, beginning in Sweden, built around its LaminarPace ambient air-drying system. Each plant would enable the local production of up to 30 million vials of thermostable dry powder vaccine, yielding up to 300 million doses. All could be transported in any climate, with no refrigerated Cold Chain. Significant reduction in carbon emissions in vaccine supply would directly help reduce many of the most important factors triggering pandemics Hjelmberg points out:

“Imbalances in the ecosystem, increased deforestation, habitat and species loss – all these directly fuel new pandemics” she says, “and yet the global Cold Chain we currently use to ship vaccines to treat these pandemics in itself is vast carbon-intense and thereby fuels more climate damage – in turn fueling more pandemics. It’s a vicious Cold Chain circle. Locally produced thermostable vaccines needing no Cold Chain would help remove vaccines from this vicious cycle. Economically it would be win-win-win-win, driving positive climate action, vaccine coverage and a sustainable development in LMI countries.”

The cost of unequal vaccine distribution

Hjelmberg argues strongly that regional vaccine manufacture and supply is crucial for global financial stability and prosperity. “According to studies (1) the global economy stands to lose as much as 9.2 trillion USD if the world fails to ensure access to COVID-19 vaccines for LMI economies” she says. “A global supply system that means some parts of the world get access to vaccines, but others don’t not only cause deaths – it spawns new virus mutations and leads to economic devastation. A new mechanism and new innovation is needed to ensure effective and sustainable ways to deploy vaccine access around the globe. Equal vaccine distribution will also minimize domestic economic damage due to interruptions in trading with unvaccinated regions. Ironically, significant parts of the economic cost in the absence of global vaccine coverage will be borne by the advanced economies, even if they manage to vaccinate their own citizens.”

Hjelmberg is optimistic about the growing agreement amongst vaccine players that new innovations and solutions for vaccine supply are urgently needed: “The cost of rolling out regional production and distribution of COVID-19 vaccines might seem high but it will be far cheaper than suffering the long-term economic effects of the pandemic. As John WH Denton, ICC Secretary General said – ‘This is not an act of charity – this is economic common sense’.

“By working together and innovating boldly we can defeat Covid-19 and improve vaccine coverage, climate action and sustainable development. Removing vaccines from the vicious cold chain cycle of global carbon-intensive supply chains could create a new virtuous cycle of sustainable growth and development, with vaccines at its heart.”

Read about Ziccum’s 6 target SDGs here

(1) https://iccwbo.org/publication/the-economic-case-for-global-vaccinations/

Ziccum AB: ‘Thermostable dry powder vaccines can play a key role in six UN Sustainable Development Goals’ – CFO

ZICCUM AB Interim Report January 1-March 31, 2021

Summary of interim report, first quarter 2021

Ziccum has announced its goals for 2021, the main goals are to enter into a first licensing agreement for one or more vaccines and to present a detailed plan to establish a production facility for filling and final packaging of dry powder, thermostable vaccines including necessary partnerships and financing plan.

During the first quarter, Ziccum extended the evaluation agreement that was concluded on October 3, 2019 with Janssen Vaccine & Prevention B.V., one of Janssen's pharmaceutical companies belonging to Johnson & Johnson. The purpose is to complete the analysis of Ziccum's air drying technology with Janssen's vaccine platforms.

During Q1, Ziccum was accepted as a member of NIIMBL, the National Institute for Innovation in Manufacturing Biopharmaceuticals. NIIMBL's mission is to accelerate the development of new biomedical manufacturing technologies in the United States.

Jan – Mar 2021
Net sales 0 KSEK (0)
Operating profit -4 387 KSEK (-3 980)
Earnings per share before and after dilution -0.46 SEK (-0.55)

Significant events during the first quarter 2021
On January 12, Ziccum announced its goals for 2021, the main goals being to enter into a first licensing agreement for one or more vaccines and to present a detailed plan to establish a production facility for filling and final packaging of dry powder, thermostable vaccines including necessary partnerships and financing plan. In the medium term (2-3 years), the goal is to establish a first facility in Sweden.

Ziccum announced on January 25 that the company has extended the evaluation agreement that was concluded on October 3, 2019 with Janssen Vaccine & Prevention B.V., one of Janssen's pharmaceutical companies belonging to Johnson & Johnson. The purpose is to complete the analysis of Ziccum's air drying technology with Janssen's vaccine platforms.

On March 17, Ziccum announced that the company had been accepted as a member of NIIMBL, the National Institute for Innovation in Manufacturing Biopharmaceuticals. NIIMBL's mission is to accelerate the development of new biomedical manufacturing technologies in the United States. Among others, the US National Institute of Standards and Technology (NIST) and the U.S. Department of Commerce founder, giving the organization opportunities to distribute federal grants to its members.

Significant events after the reporting period
No significant events occurred after the reporting period.

Summary Financial Highlights

	2021 Jan-Mar	2020 Jan-Mar	2020 Jan-Dec
Net sales	–	–	–
Operating profit, KSEK	-4 387	-3 980	-17 235
Profit after tax, KSEK	-4 416	-3 980	-17 289
Balance sheet total, KSEK	35 715	14 271	39 640
Cash flow during period, KSEK	-4 818	8 995	31 556
Cash flow per share, (SEK)	-3.00	1.25	3.75
Cash and cash equivalents, KSEK	28 802	11 058	33 620
Results per share before and after dilution (SEK)	-0.46	-0.55	-2.06
Equity per share, (SEK)	3.33	1.77	3.79
Equity ratio, %	90%	91%	92%

CEO Statement
Vaccinations are and have been one of the best ways to prevent pandemics and epidemics. Now, the need has never been greater. New travel habits, population growth, climate change and overcrowding all potentially increase the risk of epidemics and pandemics, and children are the most vulnerable; one child in five still does not receive adequate vaccination protection. Approximately 1.5 million children die each year from diseases for which vaccines are available. With the Covid-19 pandemic, many countries have come to realize the importance of taking responsibility for vaccine production, not least many countries on the African continent. Our solution described in a White Paper on our website, of a Fill & Finish production facility, may therefore be very suitable.

Ziccum has a unique and patented technology – LaminarPace ™ – which enables us to produce vaccines in dry powder form, which is not practically or economically possible with conventional technologies. The benefits are many. It increases the stability and thus the lifespan of the vaccine, it facilitates the entire transport chain from factory to patient and it enables the distribution of vaccines to new places where, for example, cold- and freezer storage is a major challenge. The result is greater vaccination coverage at a lower cost.

Ziccum's focus is described in three main areas: Development of thermostable formulations of vaccines, preparations for production on a commercial scale and external collaborations with industrial actors who develop vaccines and also, for the industry very importantly, NGOs, "non-governmental organizations".

Despite Covid-19, our internal work continues to develop thermostable formulations of vaccines. In collaboration with our academic partner, the world-leading University of Marseilles’ virus and vaccine department, several interesting and important projects are now underway. The results are very promising and are in good agreement with what we have seen before. Our work on developing a system for an industrial production environment is progressing well, and we have also worked on mathematical simulated models of the process, which has given us a deeper insight into commercial production.

We have two main goals for 2021, partly to develop concrete plans to build and establish a Fill & Finish production facility for filling and final packaging of vaccines in Sweden, and partly to continue licensing our technology. The goal of concluding a license agreement remains from the previous year. License revenues continue to be a central part of Ziccum's business model. A license agreement would validate LaminarPace and be a clear acknowledgment of the commercial value of Ziccum's offering. We are of course pleased to have entered into an extension of our collaboration agreement with Janssen, which is owned by Johnsson & Johnsson, for further evaluation of our technology in combination with their vaccine program. We are expected to be able to come up with new updates about this project during the second half of the year. We have already presented a detailed proposal on what a Fill & Finish production facility based on our technology will look like. The response from industry players has been positive and we are constantly making new contacts with potential key players to be able to carry out the project. We have shown that a Fill & Finish production facility based on our LaminarPace technology has the potential to lead to significant cost savings compared to conventional freeze-drying technology, in addition to the fact that dry vaccines can be produced without dependence on the costly and complicated Cold Chain.

Vaccines are a low-cost product in large parts of the world, which is why these results are so important. Now that we can describe a production facility, we have expanded our business model and added additional revenue opportunities. We can now have another type of discussion with both bulk vaccine suppliers and International Vaccine Organizations. The ambition to establish a production facility for dry vaccines also means that we now focus a lot on ensuring that our technology can deliver an end product that is adapted to the industry's and not least the end users' wishes and requirements. Our ambition is to be one step ahead and be able to offer a unique complete solution for how a dry-formulated vaccine is to be produced, handled and administered.

We also continue to develop our commercial work by actively processing and engaging in dialogue with various companies, interest groups and even nation states that work for better vaccine coverage worldwide. We are building deeper and stronger relationships in these arenas, we have high hopes of being able to formalize one or more collaboration in the coming year.

It is also, of course, very gratifying that we have very recently been admitted as members of the American organization NIIMBL (The National Institute for Innovations in Manufacturing Biopharmaceuticals). One of NIIMBL's main purposes is to ultimately strengthen American competitiveness in the manufacture of biological drugs, and we now have direct contact with the heavy American biotech industry. To become a member, you must in principle have some form of business in the US, which we do not have, but sometimes they make exceptions for companies with particularly interesting technology. With membership, we also have the right to apply for US federal grants channelled through NIIMBL and we can be invited to participate directly in projects without having to make applications.

In summary, we are well positioned for a very exciting future in an industry that will remain a top priority for all of us for a long time to come.

Lund, 23 April 2021
Göran Conradson
CEO

Read the full report HERE.

This press release has been submitted for publication by the company's CEO at 08.45 (CET) on April 23, 2021.

Delårsrapport Q1 2021 2021 04 20 15 59 05

ZICCUM AB supports World Immunization Week with new initiatives highlighting regional Fill and Finish plants

Ziccum AB is actively supporting the WHO’s World Immunization Week 2021, this year with the theme ‘Vaccines Bring us Closer’. CEO Göran Conradson: “We’ll be attending meetings and policy events with vaccine bodies from around the world, sharing our vision of sustainable energy-efficient regional Fill and Finish plants able to produce dry powder thermostable vaccines onsite at volume. Ambient air-drying could play a profound role in enabling all countries to be more sustainable and self-sufficient in vaccine production, bringing us all closer to the essential value of vaccines.”

The WHO World Immunization Week takes place from April 24 – 30 2021. It is a global initiative, carried out in collaboration with countries worldwide, to drive immunization, promote vaccine use and ensure that governments get guidance and technical support in implementing high quality immunization programmes. This year’s WIW is organized around the theme ‘Vaccines Bring us Closer’

During the week, Ziccum will be attending global policy events as well as launching new accessible, educational content and a podcast sharing strategic and scientific information on new innovation in vaccine formulation.

CEO Göran Conradson: “Over the last year we have all come to understand the value of vaccines like never before – and the urgent need for better and fairer vaccine access worldwide.

Ziccum is planning to develop a series of small, modular Fill and Finish plants enabling regions to produce up to 30 million vials of dry powder vaccines, yielding up to 300 million doses, using its LaminarPace ambient air-drying technology. The first such plant is planned to be established in Lund, Sweden before being rolled out globally.

Each Fill and Finish plant would be highly energy-efficient, with a single site measuring just one sixth of the area of a soccer field. The plants will produce thermostable dry powder vaccines, which unlike today’s delicate glass-vial liquid vaccines can be stored and transported with no need for costly fridge and freezer supply chains.

“Thermostable dry powder vaccines don’t need the enormous plants, large teams or huge amounts of energy that conventional freeze-drying vaccine plants require” Conradson says. “We estimate that our new plant will use 80% less energy, 65% less OPEX and 50% less CAPEX costs than today's freeze-drying plants. We all know that reliable local vaccine access powers both sustainable development and pandemic preparedness. World Immunization Week is a great opportunity for us to get our story out there and meet with governments, international governmental organisations, non-governmental organisations and vaccine manufacturers across the globe who are also committed to new innovation in vaccine formulation.

“Only by working together can we optimise vaccine coverage – thereby saving lives, strengthening health systems and ensuring economic prosperity, in the face of pandemic and epidemic threats.”

Read more about WHO World Immunization Week here

#VaccinesWork to bring us closer

ZICCUM AB supports World Immunization Week with new initiatives highlighting regional Fill and Finish plants

ZICCUM AB supports historic new CEPI and African Union agreement to enhance vaccine manufacturing and R&D in Africa

A ground-breaking new memorandum of understanding between CEPI (The Coalition for Epidemic Preparedness Innovations) and the African Union was signed following a prestigious two-day virtual event, attended by Ziccum, hosted by the Africa Centres for Disease Control and Prevention (Africa CDC) and the Africa Union, on 12-13 April 2021. Ziccum CEO Göran Conradson: “The shared commitment at the event to speeding up vaccine manufacture and Fill and Finish capacity within Africa was inspiring. We warmly welcome the new aim of increasing local production of vaccines across Africa by up to 60% by 2040 and believe Ziccum technology could play a valuable role.”

The event, ‘Expanding Africa’s Vaccine Manufacturing’, was hosted by an eminent panel of high-profile heads of states, policy makers and stakeholders including the President of South Africa, HE Matamela Cyril Ramaphosa, the Director-General of the World Trade Organization, Dr Ngozi Okonjo-Iweala, and Director General of the World Health Organization Dr Tedros Adhanom Ghebreyesus.

Dr John Nkengasong, Director of the Africa CDC’s opening address highlighted Africa’s vision of ensuring that “Africa has timely access to vaccines to protect public health security, by establishing a sustainable vaccine development and manufacturing ecosystem in Africa.”

The two-day event aimed to highlight Africa CDC’s efforts to push for a clear programme for manufacturing and development of vaccines in Africa. The lack of vaccine manufacturing, Fill and Finish and Cold Chain capacity on the continent has led to huge barriers in their ability to access sufficient vaccine supplies across the region. Instead, Africa has relied mainly on overseas imports, which account for 99% of their vaccine supplies. This has resulted in less than 2% of the world’s vaccines being administered within the African Region.

All panellists expressed their commitment to speeding up vaccine manufacturing across the continent, as well as increasing regional Fill and Finish capacity, with the aim to reduce vaccine imports to the African continent by around 40%, and to be fully responsible for the manufacture of vaccines for three emerging diseases including Ebola, Lassa fever and Rift Valley disease by 2040.

Ziccum CEO Göran Conradson: “Let’s remember the Conference’s closing call to “act now, act collectively – and act differently” as we move forward! This new agreement is of profound strategic and social importance – for Africa and the entire global vaccine arena. We applaud CEPU, the Africa Union and Africa CDC. We embrace the aspiration to increase local vaccine production in the continent from today’s lamentable 1% up to 60% by 2040, and to create regional vaccine research and manufacture hubs in 5 key regions. The Conference ended with the words of Nelson Mandela – “We always think something is impossible until it is done” – this event showed the strength of will out there now for making new possibilities in vaccine manufacture and distribution. So let’s do it. Let‘s set vaccines free.”

To address the panels’ repeated calls for increased regional vaccine development capacity, Ziccum offers their novel method.

Ziccum is currently planning to develop a series of aseptic modular Fill and Finish plants enabling individual African Nations to produce up to 30 million vials of thermostable dry-powder vaccines using Ziccum’s patented LaminarPace air-drying technology. This would equate to 300 million doses. According to Dr Amadou Alpha Sall, Director of the Institut Pasteur de Dakar in Senegal, Africa needs to be able to produce 200 million doses of COVID-19 vaccine, thus Ziccum’s plants will produce greater vaccine supply than the expected demand which allows potential to greatly enhance export opportunities. Ziccum’s Fill and Finish plants will drive self-sufficiency and security of vaccine supplies across the African Nations to enable them to better respond to COVID-19, prepare for inevitable future pandemics and continue routine immunization.

The event led to a historic signing of a memorandum of understanding between CEPI and the African Union Commission. Ziccum can contribute towards the development of infrastructure and expertise to support technology transfer and develop national and regional manufacturing capacity, that will enable African countries to take full ownership of their national health security whilst eliminating the need for the cold chain, minimising vaccine wastage and greatly reducing energy usage.

Find out more information about the event here.

Event programme agenda here.

You may access recordings of the conference below:

Day 1 of conference recording | Access code: b8k#&Wj4

Day 2 of conference recording | Access code: 93k5t@Ub

For more information about Ziccum, please contact:

Göran Conradson: CEO Ziccum AB
Mail: conradson@ziccum.com
Mobile: +46 709 61 55 99

ZICCUM AB supports historic new CEPI and African Union agreement to enhance vaccine manufacturing and R&D in Africa

MAPPING THE FLOW: Industrial process specialist models Ziccum dry powder vaccine methodology

Dr Anton Löfgren is an industrial process engineer specialising in unit operations in pharma manufacturing. For four months he visited Ziccum to develop mathematical models of Ziccum’s LaminarPace vaccine air-drying methodology for future industrial application and design. What is his view of the viability of ambient air drying on an industrial scale, and – if the method is as simple and scalable as claimed – when can we expect to see uptake?

Dr Anton Löfgren is a graduate from the Faculty of Engineering at the University of Lund and the author of Downstream processes for next-generation biologics. He is now completing his project at Ziccum AB developing 2D and 3D mathematical models that set parameters of the system’s air flow for future industrial design and development. As a biotech engineer Löfgren has modelled a wide range of industrial pharmaceutical manufacturing processes before including chromatography and membrane processes. This is the first time he has worked with ambient air drying connected to pharmaceutical production. As a previous collaborator with scientists from Novo Nordisk, Swedish Orphan Biovitrum and others, how has he found the novel process and what did he expect?

“Ambient air drying could clearly be an efficient industrial process and I think it would be relatively easy to scale up” Dr Anton Löfgren, industrial process specialist pharmaceuticals.

“I had no preconceptions about air drying for pharmaceuticals. Obviously, I was interested because it is a new technology, but I’ve found it is a relatively simple concept and I think it is a smart, effective process. I think LaminarPace is definitely on its way to becoming a mature, stable system and as a potential industrial process it is energy-efficient, achievable and a good idea. We need to know the flow rate settings and optimal parameters, which is why I’m here, and in industrial pharma production validation, quality control and so on is a long process – but the basic principles are sound, and it is a strong idea.”

How do you expect the model you are developing now to be used? “The model is about helping us find the optimal running conditions and to start with it will be a big help for development purposes and in the industrial design area.”

What kind of timescale do we see for adoption of new production processes in pharma manufacturing? If, as has been said, the ambient air-drying process itself is comparatively simple, why is innovation and uptake of new process in production often slow?

“I covered that question in an entire section in my book” Löfgren says. “In large-scale pharma manufacturing the cost driver is not efficient production, it’s time to market. If a manufacturer has spent 10 – 15 years developing a new drug, they just want to get that drug to market as quickly as possible. So, freeze drying for example, may be expensive, it may not be fantastically efficient – but it is well-established. Novel relatively untested production methods are always going to face obstacles to fast adoption. However, given our models, this could clearly be an efficient industrial process and I think it would be relatively easy to scale up. The key issue will be who takes the first step. I think once it has been seen to perform successfully in one facility, uptake could be very rapid and you could see a large number of manufacturers choosing it even within a couple of years. If ambient air-drying produces vaccines that can get to wider markets faster manufacturers will quickly realize they can’t afford not to use it. At first, initial adoption could take time – but then we could very well see wider uptake more quickly.”

In parallel with the modelling work Ziccum has upgraded and improved features on a new LaminarPace rig in Gothenburg, with a larger array of sensors. “We will then have additional humidity, pressure, temperature and flow rate sensors” Löfgren says, “the extra data from these will contribute to and verify the models of the flow and temperature behaviour in the centre of the drying chamber. The modelling has already uncovered important insights into the central features of the air drying – and if anything I think it has confirmed the essential simplicity of the central concept.”