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The team from ZHAW, headed by Prof. Dr. Gernot Boiger, has collaborated with the Ziccum team at Lund to produce a detailed application for their joint project, which has already generated valuable data on LAPA – Ziccum’s unique unique ambient drying system that can dry vaccines and biologics at room temperature, producing robust dry formulations that require no refrigeration or freezing. In the first phase of the proposed project the teams plan to work on 3D modelling of LAPA’s flow, particle formulation and scale-out. A projected final phase aims to further develop the 3D modeling.

Prof. Dr. Gernot Boiger, Head of Research Area Multiphysics Modelling and Imaging at the School of Engineering, ZHAW: “In this collaborative effort we haven’t just learned to work together seamlessly, we have also managed to compose a strong Eurostars proposal. This proposal will be the foundation for carrying out innovative R&D together over the coming years. I think that bringing the teams of Ziccum and ZHAW/ICP together has really worked well.”

Ziccum CEO Ann Gidner: “We’re already hard at work with our great partners at ZHAW,who share our drive and commitment to this unique and much-needed drying technology. We believe this project will significantly strengthen and accelerate the development of LAPA, delivering insights into the unique properties of the particles LAPA can formulate, and accelerating its industrialization.”

About LAPA: LAPA is Ziccum’s unique ambient drying system for vaccines and biologics. In the field of vaccines, LAPA formulates thermostable vaccines that can withstand elevated temperatures without requiring refrigeration or freezing. In the field of biologic drugs, LAPA meets the unmet need for an ambient drying method, drying delicate proteins and viruses at room temperature without the damaging effects of heat. This gives particles that typically retain robust structures and high API activity, making them thermostable – and highly valuable for novel formulation techniques.

About Eurostars: Eurostars funds innovative collaborative R&D projects across 37 member countries, specializing in projects that partner SMEs with larger companies, universities and research organizations. Eurostars is co-funded by the EU Horizon 2020 Framework Programme and EUREKA, the world’s largest public network for international cooperation in R&D and innovation.

For more information about Ziccum, please contact:

CEO Ann Gidner and Chairman Fredrik Sjövall will attend Nordic Life Sciences Days in Malmö, 28 – 29 September, and Bio-Europe, the largest industry event for biopharma professionals in Europe, in Leipzig on 23 – 26 October.

The company’s CEO together with Scientific Director Fabrice Rose will attend the New Updates in Drug Formulation & Bioavailability conference in Copenhagen on September 6, and the 23rd World Vaccine Congress Europe conference in Barcelona October 11 – 14.

Ziccum CEO Ann Gidner: “Since my appointment in May we have constantly emphasized our commitment to building new strategic dialogues and relationships within the industry. Our unique ambient drying technology for vaccines and biologics is an enormously valuable technology. Together with our Chairman and Scientific Director I look forward to sharing our science and offering at these important industry events.”

BOOK A MEETING ahead of the events with CEO Ann Gidner, Chairman Fredrik Sjövall or Scientific Director Fabrice Rose here:

Ann Gidner CEO – Mobile: +46 722 140 141
e-mail: gidner@ziccum.com

Fredrik Sjövall, Chairman – Mobile: +46 706 45 0875
e-mail: sjovall@ziccum.com

Fabrice Rose, Scientific Director: +46 709 802 520
e-mail: rose@ziccum.com

Thermostable vaccines that can withstand heat in any climate, anywhere in the supply chain, are in high demand – as growing numbers of national and international bodies seek to improve pandemic preparedness and establish tougher, more robust vaccines in a rapidly warming world.

Now, Ziccum AB and the Zurich University of Applied Sciences (ZHAW) are applying for funding from the Eurostars funding body for a joint project that will develop the 3D modelling stage of LaminarPace (LAPA) – Ziccum’s unique room-temperature drying system that formulates thermostable vaccines that require no refrigeration or freezing. The new application is part of Ziccum’s sharpened strategic focus on continuously evaluating soft funding opportunities that strongly match Ziccum’s offering and its current state of development.

Eurostars funds a wide range of highly innovative collaborative R&D projects across its 37 member countries. All Eurostars projects partner SMEs with larger companies, universities and research organizations. Eurostars is co-funded by the EU Horizon 2020 Framework Programme and EUREKA, the world’s largest public network for international cooperation in R&D and innovation.

The project will be carried out by the ICP Institute of Computational Physics at the School of Engineering (SoE) at ZHAW, and the Ziccum team at its labs in Lund, Sweden. An initial workshop between the two teams took place in Lund, Sweden on June 15 and intense authoring of the grant application is now underway.

The project aims to strengthen, support and accelerate the development of LAPA – offering high-value insights into its unique particle properties, and accelerating and optimizing industrialization. The first phase will focus on modelling flow, particle formulation and scale-out. A projected final phase will further develop the 3D modeling to accelerate sales, partnering and tech transfer to pharmaceutical and CDMO (Contract Development and Manufacturing Organizations) partners.

Strengthened focus on soft funding
As stated, Ziccum now has a sharpened strategic focus on identifying and prioritizing soft funding, opportunities that best match the company’s offering and current phase of technology development. As a consequence, the company has decided not to apply for the previously-mentioned CEPI funding as this is targeting well-established manufacturing organizations that can implement thermostable vaccine facilities globally. Instead Ziccum is identifying other funding projects for earlier-stage companies, enabled by strong current interest in and demand for thermostable vaccines and novel drying methods that can achieve them.

Ziccum CEO Ann Gidner: “3D modeling is an integral part of our technology development – so the opportunity to partner with such an expert team and receive funding for this stage is a win-win for us – and, ultimately, our prospects and partners. 3D modelling and its potential resulting tools will offer partners the chance to explore the benefits to be gained from ambient drying from every angle. Our partners at ZHAW are fully committed to the project and our unique ambient drying methodology, and morale and momentum are high.”

Ziccum has chosen TEKECELO from competing vendors, including larger suppliers with less advanced knowledge of nebulizers, for the further development of its core nebulizer component. It is an innovative manufacturing company specializing in mechatronic and piezoelectric technology with an advanced portfolio of nebulizers, headquartered in Mougins, just outside Cannes, France.

Positive onsite audit
The decision follows an onsite audit of the company facilities carried out in June by a Ziccum team of senior formulation specialist Fabrice Rose, technical operation manager Rasmus Lund and senior project manager Stefan Qvarnström.

Fabrice Rose: “The nebulizer is a core component of the LaminarPace (LAPA) ambient drying system. The more accurate we can be with the humidity and spray rate created at nebulization, the better prepared we will be for progressing through each step of GMP compliance.”

Ziccum CEO Ann Gidner: “We are confident this will be a productive collaboration. We look forward to progressing this vital work.”

Ziccum expects to receive the first prototypes of the new nebulizer by Q4 2022.

The Emerging Virus Unit, located close to the faculty of medicine in Marseille, is one of Europe’s leading virology labs. Its activities relate to preparing for epidemic phenomena and implementing diagnostic, therapeutic and preventive countermeasures. The unit does not carry out pharmaceutical R&D and does not develop new vaccines, unlike Ziccum’s current three partners in its streamlined project portfolio.

In its two-and-a-half-year long collaboration the Unit has been a supportive partner with a strong shared commitment to advancing thermostable formulations of biologics and viruses for easier storage and transportation.

Fabrice Rose: “This collaboration played an important role in developing LaminarPace (LAPA), our ambient drying system. In particular, working on solving three key challenges led to valuable learnings and the development of many new features, despite a general slow-down during the Covid-19 pandemic.”

Safety and biosafety: Key learning #1
As a virology rather than pharmaceutical facility, in Marseille LAPA was installed for the first time in a Biosafety Level 3 (BSL-3) laboratory. BSL-3 labs are for the study of infectious agents that can cause lethal infections. Research must be carried out in sealed, sterile biosafety environments designed to be easily cleanable.

Fabrice Rose: “This taught us a lot about which issues to improve for long-term use of LAPA in that type of facility and led to new features such as our sealed glove box and powder collector cup, plus to the exploration of new ways of sterilizing and cleaning the system. We now have BSL-2 status in our facility in Lund and what we learned at Marseille gave us valuable lessons in achieving that.”

Formulation: Key learning #2
Fabrice Rose: “This was the first time we tested and worked with LAPA on live viruses. It gave us excellent insights into the challenges of working with these types of vaccines and we made significant progress in our knowledge of new formulations that will stand us in good stead for future projects.”

A specific example was Ziccum’s work on envelope viruses. Fabrice Rose: “These are one of the most challenging types of vaccines to stabilize. If you damage the viral envelope in any way, your vaccine won’t work anymore. Thanks to Marseille we started to identify much better where stress situations might happen and work on new formulations that would overcome them. It is all about how you combine formulation and process design and our experience in Marseille gave us key insights into that.”

Humidity control: Key learning #3
“In Marseille we identified two main issues around humidity: The need for better control of humidity inside LAPA, and the need to better control the system’s surrounding humidity. Our work solving these positively impacted LAPA’s development enormously,” says Fabrice Rose.

Despite a slow-down during the Covid-19 pandemic, commitment was strong on both the Swedish and French side: “LAPA is an entirely new unit operation, so it was vital to be able to map out where we were with the system and how best to drive development. This project enabled that and ignited a range of ideas that will play a crucial role in our commercial offering.”

On March 11, 2020 the pharmaceutical industry entered a new era, as the WHO declared COVID-19 a global pandemic: “The speed at which new vaccines were developed is fantastic, and that impetus and investment continues,” says Ann Gidner. “For us it means we no longer have to sell the big-picture benefits of thermostable vaccines. Now is the time for action in our work with pharmaceutical companies and CDMOs (Contract Development and Manufacturing Organizations). We are prioritizing building direct discussions and projects with those organizations.

“There are several synergies and strong connections to previous experiences and positions in my career and I believe I have a relevant network for enabling new partnering dialogues. We have had several initial discussions with industrial players since I started, and I experience a high level of interest in Ziccum’s technology. My specific experience driving new businesses for CDMOs will also be crucial for my position at Ziccum as this group of companies are an important new target for us.”

From vision to action – platforms and projects
Ann Gidner has brought a sharper focus to Ziccum’s projects and pipeline work in her first month as CEO. The company has streamlined its project portfolio down to three high-value ongoing feasibility and evaluation studies – two with leading pharma corporations, and one with a major research institute in vaccination in the Nordic region. Ziccum is also now prioritizing three key, high-potential vaccine platforms, including mRNA.

“It’s all about action and applicability,” says Ann Gidner. “We have eliminated demanding low-value projects and are focusing only on projects which will help accelerate our technology from concept to first licensing deal. Those projects which deliver absolutely the most value for us and our clients – in terms of patent potential and landing licensing deals.”

Ziccum recently announced that an ongoing pilot evaluation study agreement with a leading pharmaceutical corporation has been extended following the completion of the latest stage of the project. Ziccum will ship the dry-formulated study materials from its facilities in Lund to the corporation’s labs at the end of June, where they will be evaluated.

Explore Ziccum’s three key vaccine platforms.

Strong mRNA focus
Ziccum has made major strategic investments too into new facilities and equipment for mRNA/LNP (Lipid Nanoparticles), seen by many as representing a new era in vaccinology. LaminarPace, the company’s ambient drying system, has already achieved first results with early dry formulations of LNP materials, a dataset which will enable further optimization for these crucial delivery vehicles that enabled both the Pfizer-BioNTech and Moderna COVID-19 vaccines.

“Our work with LNP and mRNA materials is particularly exciting,” Ann Gidner says. “Remember, people were skeptical about mRNA COVID-19 vaccines at first, but the drive, research and investment in developing these created enormous opportunities. And those opportunities continue today. mRNA is one of the most high-potential areas in the industry right now.”

Read about Ziccum’s focus on mRNA vaccines here

Growing industrial maturity
Ziccum is continuously developing the industrial capabilities of LaminarPace, aiming for eventual GMP manufacturing status. The current system is the fourth generation, with nitrogen having replaced air, to further reduce moisture, a new sealed powder collector, to increase safety, and an advanced array of sensors to measure drying flow.

Ann Gidner: “We are very happy to just have the fourth generation equipment installed this week. Our technology development is maturing rapidly, achieved in parallel with ongoing project work, resulting in increased confidence from our external collaborators.”

“I have taken several technologies and products through to market and licensing deals, and I am convinced that Ziccum has excellent potential.” says Ann Gidner.

Read more about LaminarPace’s technology development here.

Long-term financing
Another important strategic objective is to secure long-term financing for Ziccum, increasingly important as global financial conditions are becoming more challenging.
“Generating revenues from early co-development and feasibility programs is one very important factor which can contribute significantly. Another opportunity is to continuously evaluate soft funding in the form of specific industry grants where we can identify a strong match with our technology and offering. We are currently working actively on a selection of soft funding opportunities where we believe the chances are favorable for being granted substantial contributions to our long-term financing plan.”