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The study is analyzing Ziccum’s drying capabilities on a major vaccine platform technology using LaminarPace TM – Ziccum’s ambient dry formulation system for vaccines and biologics. Ziccum is now in the process of packaging and labeling the dry formulated study materials and will ship them to the company’s labs at the end of June.

LaminarPace TM can gently dry liquid biologics and vaccines at room temperature with the active ingredient remaining intact. Dry-formulated thermostable vaccines could be transported with no need for refrigerated transport or storage – potentially solving a perennial challenge for the global vaccine industry. Ziccum has recently sharpened the focus of its research onto three major vaccine platforms that are the base for many existing vaccines on the market, and a wide range of new vaccines in development.

Ziccum has continued the technological development of LaminarPace TM throughout the present collaboration as it continues the system’s scale-up towards eventual GMP (Good Manufacturing Practice) status for industrial manufacture.

Ziccum CEO Ann Gidner: ”The positive and constructive commitment on both sides through this collaboration underlines how valuable the project is for all of us. At Ziccum now we are focused firmly on this kind of high-value project – projects which can generate new data, new formulations and ultimately new patents and partnerships.”

Ziccum is one of a few European members invited to join NIIMBL, becoming a member in March 2021. NIIMBL is a public-private partnership that helps fund an ambitious range of research projects to accelerate biopharmaceutical innovation in manufacturing and supply. Members include industry, academic and government organizations within pharmaceutical manufacture and supply.

Anna Lönn, Ziccum’s Development Director has been elected to NIIMBL’s Technical Activities Committee (TAC) for the period 2022 – 2023. Anna, who joined Ziccum in September 2021 from TetraPak, has driven significant development throughout the company together with a highly skilled development team. Since September they have established the company’s expanded lab facilities and mRNA capabilities, and driven ahead its ambitious Quality by Design-led program of technological development. Fellow NIIMBL members on the TAC include representatives from noted vaccine developers, biologics companies working on viral vectors and viral vaccines, and academics from leading US universities within bioprocesses and pharmaceutics.

Ziccum Chairman Fredrik Sjövall: “The election of Anna really reflects her outstanding professionalism and expertise; she will bring fantastic qualities to fascinating work. We welcome the opportunities for networking and partnerships that TAC brings, and the possibilities for soft funding that can come through involvement with organizations like NIIMBL and CEPI (the Coalition for Epidemic Preparedness Innovation.) Our recent invitation from CEPI to submit an application for their soft-funded project on innovation in thermostable vaccines, plus our ongoing work with NIIMBL, are all good examples of the awareness and interest in the industry around our technology. We look forward to making a valuable contribution.”

READ MORE

• Read more about NIIMBL here.
• Read more about LaminarPace here.

Ziccum is now focusing on a targeted program of technology development, in parallel with a streamlined project program targeting three key vaccine platforms. The strategy will focus and drive forward business development and significantly strengthen the company’s offering to industrial partners. It will also serve as a foundation for generating new patents – not least in the area of mRNA.

Chairman Fredrik Sjövall: “Our early collaborations and discussions with external parties provided strong guidance on where we should put our focus in terms of technological development in order to increase the probability of entering commercial agreements. For example, we needed to have an industrial conceptual design for LaminarPace (LAPA), so we did that with our Fill and Finish blueprint with KeyPlants. These new targeted developments are also built on key learnings from external collaborations.”

Driven by QbD

As it progresses towards its ultimate long-term goal of establishing LaminarPace (LAPA) as an integrated part of the industrial production of vaccines, Ziccum works using a highly focused Quality by Design (QbD) approach. QbD is a systematic risk-based methodology, recognized and encouraged in pharmaceutical manufacture by the FDA, that identifies potential risks and variables in all aspects of product manufacture and development.

The current LAPA system is the fourth generation in development, with several key improvements having been implemented – from critical components and material selection and design (for example Teflon tubing replacing silicon and Nitrogen replacing air to further reduce moisture), to advanced sensor arrays inside the system to map and monitor the flow of the drying procedure itself, to software and control optimization and sealed glovebox collection to ensure the safety of the operator and the product.

Key priority areas in LAPA’s development towards eventual GMP industrial manufacturing status include continuing to explore ways to optimize production capacity, reproducibility, reliability, cleanability and sterilization. The current focus areas all impact on these metrics.

KEY TECHNOLOGY DEVELOPMENTS UNDERWAY – AND RECENTLY COMPLETED

New powder collector: Ziccum has now installed a new sealed, contained collection unit that enables the inhouse study of a wider range of test substances. The new unit increases safety, reduces humidity and enables quicker, more efficient collection of drier formulations.

New nitrogen usage: Ziccum has now introduced Nitrogen gas (N2) into the drying column to replace air. N2 is a highly efficient remover of moisture. The first nitrogen-based generation of LAPA is installed and has performed well in tests.

New nebulizer: LAPA has been used throughout its history to dry small amounts of test substance in a lab setting. The system’s nebulizer feature is a key component in optimizing the system’s capacity, reproducibility and reliability. Ziccum has carried out a first phase in optimizing the nebulization step and is now collaborating with a specialist engineering partner in a second evaluation stage. These external collaborations and partnerships are expected to continue in LAPA’s ongoing development. The current stage of nebulizer development is estimated to be completed by H2 2023.

New membrane: The central membrane in LAPA’s drying column is a critical component. Intensive work is currently underway in optimizing the membrane for future GMP compatibility – examining its porosity, mounting and materials for industrial setting. This current development stage will be completed by H2 2023.

Fredrik Sjövall: “LAPA is a highly innovative system with unique capabilities. The projects we are now focusing on are crucial steps towards reaching the industrial production environment – increasing the value of our technology, and therefore the opportunities for it to enter into commercial agreements. The projects will be run in parallel with our evaluation programs together with external partners, and our internal mRNA / LNP work, and will form the basis for new patent applications – both for ourselves and our customers.”

In April 2022 Ziccum AB expanded into larger office and lab facilities at its base in Lund. The expansion includes the recruitment of a new Project Manager and two new Development Engineers, and key investments focused around mRNA/LNP – one of the three key vaccine platforms Ziccum is now targeting as part of its more focused strategy on projects and platforms.

Strengthening Ziccum’s inhouse mRNA/LNP capabilities

As Ziccum stated in its 3 March 2022 update, generating data on dry-formulated mRNA/LNP materials is a key strategic priority for the company. Covid-19 has highlighted the efficacy and high potential of mRNA/LNP as a vaccine platform enormously and both research and demand in the field is intensive.

In December 2021 Ziccum installed a microfluidics system, ‘Ignite’ NanoAssemblr, that will enable the company to generate its own mRNA/LNP materials at R&D scale. The Ignite system is now fully installed and operational.

In parallel, a new cell lab that enables in vitro studies of key biological properties is being set up. As well as offering specific advantages in the current development of mRNA/LNP, in the longer term the new cell lab also gives Ziccum the possibility of generating relevant biological data on other platforms and substances in future programs. Work on the new cell lab began in December 2021 and it is now being installed in full in the company’s new premises. It is estimated that the new cell lab will be fully operational in Q2 2022, generating its first data in Q3 2022.

Chairman Fredrik Sjövall: “These strategic investments will make us more independent and competitive in the high-potential field of mRNA/LNP. They will enable us to pursue our own mRNA/LNP studies and they will strengthen our proprietary offerings around mRNA/LNP – serving as a robust platform for creating new patents in this exciting area.”

With new CEO Ann Gidner beginning her role on May 9 and the company expanded into larger premises in April, Ziccum is now focusing on three key vaccine platforms in parallel with a streamlined project program.

Chairman Fredrik Sjövall: “This strategy will focus and drive forward business development and significantly strengthen the company’s offering to industrial partners. It will also serve as a foundation for generating new patents – not least in the area of mRNA/LNP (Liquid Nanoparticles).”

GENERATING NEW ROBUST DATA: A TOP PRIORITY
Ziccum has achieved positive preliminary data in tests with individual materials across several different vaccine platforms, as reported in December. Now however the company is focusing on gathering further data from a select target group of three key platforms:

Viral Vector platform using Adenovirus. Four major Covid-19 vaccines already use adenovirus vaccine vectors as a platform. The platform enables efficient gene transduction and research is ongoing in a wide range of indications, including in major projects in Sweden and the Nordics. Ziccum has worked extensively with adenovirus and in January 2019 submitted a patent application for a temperature-stable, dry formulation of Adenovirus.

Subunit vaccine (adjuvanted) platform: This platform is also being used in major Covid-19 vaccine candidates. Instead of using the whole pathogen, protein-based adjuvant vaccines use a defined protein antigen from the pathogen which can be recognized by the body’s immune system to provoke an immune response. Protein-based vaccines have been successfully developed over recent decades to treat diseases from diphtheria to tetanus. Ziccum is working on this platform in in collaboration with a major research institute in vaccination in the Nordic region.

mRNA/LNP vaccine platform: Generating data on dry-formulated mRNA/LNP materials is a key strategic priority for Ziccum, as stated in the 3 March 2022 update. Covid-19 has highlighted the efficacy of mRNA/LNP as a vaccine platform enormously. Ziccum is now expanding its in-house capabilities and has recently made major investments in new facilities and pecialized equipment for manufacturing and evaluating dry formulations of mRNA/LNP materials – investments which will be covered in an upcoming Press Release.

Chairman Fredrik Sjövall: “These investments will make us more independent in pursuing our own mRNA/LNP studies and intellectual property. Focusing in on select high-value projects with prestigious partners, plus our own in-house work on mRNA/LNP, will increase the value and range of data we can deliver to the industry. After years of working with diverse substances across a large number of platforms it brings new focus and impetus to our work and value creation.”