Grants projects – Polbionica

3D Bioprinted Bionic Pancreas as a Therapy for Type 1 Diabetes

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Grant for the 3D Bioprinted Bionic Pancreas as a Therapy for Type 1 Diabetes

The project is co-financed by the European Union through the European Regional Development Fund under the European Funds for a Modern Economy Programme.

The Bionic Pancreas-ATMP®

(Advanced Therapy Medicinal Product) developed by our team is an advanced 3D-bioprinted organ composed of a three-dimensional cellular scaffold and a functional vascular network. Both components are fabricated using proprietary 3D bioprinting technologies and patented bioinks that provide an optimal microenvironment for pancreatic islets obtained from donors or derived from a patient’s own cells.

The Bionic Pancreas-ATMP® can be bioprinted on demand and safely preserved for up to one week in a dedicated bioreactor system. The ResearchLine™ Bioreactor maintains controlled tissue culture conditions and enables precise evaluation of the printed organ’s quality, functionality, and safety prior to transplantation.

The bioprinted bionic pancreas is capable of autonomous, physiological secretion of insulin, glucagon, and C-peptide in a manner consistent with the function of a naturally transplanted donor pancreas.

Project value: PLN 16,994,307.96

European Funds contribution: PLN 10,395,499.94

Project duration:

January 1, 2025 – October 31, 2029

Project Objective

The objective of this project is to develop the world’s first fully functional, 3D-bioprinted Bionic Pancreas — ATMP® (classified as a cATMP, Combined Advanced Therapy Medicinal Product) intended for transplantation in patients with advanced type 1 diabetes or chronic pancreatitis.

Polbionica is a leading Polish company in the field of 3D bioprinting and biomaterials. The company brings together highly qualified researchers, scientists, and medical professionals whose mission is to improve the lives of patients with type 1 diabetes and chronic pancreatitis.

The innovation of this solution lies in the application of advanced 3D bioprinting technology to restore the body’s natural ability to regulate blood glucose levels. This approach has the potential to provide long-term independence from insulin injections while addressing the critical shortage of transplantable organs.

The Bionic Pancreas — ATMP®, featuring a fully vascularized structure, has successfully completed preclinical studies in large animal models (pigs), demonstrating strong results. The technology is now ready to advance into first-in-human clinical trials to evaluate its therapeutic efficacy.

A key milestone of the project will be the initiation of the first clinical trial involving patients with type 1 diabetes or chronic pancreatitis, aimed at validating the bionic pancreas as a fully functional transplantable organ.

In parallel, we plan to obtain CE marking for our proprietary bioinks as Class III medical devices and for the bioreactor as a Class IIa medical device. This will confirm compliance with European safety, health, and environmental standards. Achieving these certifications will enable market authorization for cATMP-based solutions, allowing commercialization of organ bioprinting systems across the
European market, targeted for 2028.

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Inne projekty

Development of Bioinks for 3D Bioprinting

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Development of Bioinks for 3D Bioprinting

Project: “Development of Bioinks for 3D Bioprinting Based on Chemically Modified Porcine DECM, Enriched with Recombinant Hybrid Proteins, Nanomaterials, and Synthetic Polymers,” co-financed by the National Centre for Research and Development under the “Modern Material Technologies” TECHMATSTRATEG III program.

Implementation period: 01.01.2021 – 31.03.2024.

Total project cost: 22 444 594,83 PLN

NCBR funding: 21 962 857,33 PLN

The aim of the project was to develop a package of bioink modifications (including the production of recombinant hybrid protein) based on decellularized extracellular matrix (dECM) from porcine pancreas and meniscus, enhancing the efficiency of the 3D printing process and the durability of the obtained prints. As part of the project’s tasks, research was conducted to produce a ready-to-commercialize product in the fields of biotechnology, nanomaterial engineering, chemistry, and physiology.

It is worth noting that the products and technologies developed within this project have been secured by patents. Given the significant challenge posed by the lack of organs for transplantation in patients with type I diabetes and meniscus injuries, the implementation of this project carries substantial social and economic value.

3D bioprinting has become an extremely versatile tool in the fields of biological sciences and regenerative medicine over the past decade.

It is used in the production of bone defect implants, and increasingly in the construction of functional organs such as the pancreas, lungs, liver, heart, and skin. Moreover, tissue engineering is utilized in biotechnology research, in the creation of disease models for cancer, and in screening compounds in drug production. To achieve the desired tissue construct, a range of cells, methods, and materials can be used in 3D bioprinting, depending on the nature of the printed object.

The bioinks used in 3D bioprinting exhibit a very wide spectrum of biophysical characteristics: viscosity, printability, and degradation. Additionally, they must provide favorable conditions that allow for cell embedding and differentiation, without cytotoxicity.

The technology of 3D bioprinting is based on creating three-dimensional structures from living cells, which are suspended in a biocompatible hydrogel called bioink.

This hydrogel enables precise shaping of the printed object. Depending on the type of cells used, diverse research models can be obtained.

Bioinks should exhibit a wide range of biophysical properties, such as printability, viscosity, degradation rate, and the ability to gelate. These properties allow for the creation of precise and stable scaffolds, providing suitable conditions for cells to embed within the structure. We have successfully developed our own bioinks that meet all of these criteria.

Multidisciplinary Consortium

Multidisciplinary Consortium The project was carried out through the collaboration of a multidisciplinary consortium with significant experience in creating necessary materials for printing prototypes of bionic organs.

The consortium comprises the following centers and teams:

Foundation for Research and Development in Science (FBiRN), along with a team led by Dr. Michała Wszoły, who developed the technology for producing bioink based on the decellularization of porcine pancreas and printed a prototype of a bionic pancreas.

Team led by Prof. at the Center for Advanced Technologies, Adam Mickiewicz University (CZT UAM). Scientists from the team specialize in bioprinting meniscus using bioink based on porcine meniscus dECM and mesenchymal stem cells.

The consortium was supported by the Warsaw Medical University (WUM). Prof. Artur Kamiński – Director of the Biostructure Center, along with his team, has extensive experience in analyzing the toxicity of materials in animal models.

The business partner of the consortium was Polbionica, responsible for conducting part of the research and commercializing the obtained results.

As part of the implemented project, work was also carried out, resulting in the development of two unique recombinant hybrid proteins that combine functional domains of silk and elastin (p-SE17) and resilin and elastin (p-RE15).

The p-SE17 protein combines elastin and silk, exhibiting high solubility in aqueous buffers and providing flexibility to the final product. It significantly improves the rheological and mechanical properties of biomaterials, especially elasticity. Combinations of RGD and ZIP domains provide structural stability, creating a favorable microenvironment for seeded cells. With the potential for remodeling polymeric biomaterials, it enables high-resolution 3D printing of structures with complex spatial architecture.

The p-RE15 protein combines resilin and elastin to obtain unique mechanical, physicochemical, and biological properties. It contains RGD sequences and matrix metalloproteinase cleavage sites, allowing seeded cells to appropriately adjust the space by remodeling 3D structures. It strengthens the rheological properties of biomaterials, making them ideal for advanced medical 3D printing technologies.

KEY FEATURES

These innovative recombinant hybrid proteins are produced in an economical prokaryotic expression system, without the use of detergents or surfactants, making them ideal additives to bioinks. Resilin and silk sequences enhance plasticity, while resilin and elastin increase the elasticity of the printed product. These proteins create a favorable microenvironment, promoting cell colonization, migration, proliferation, and growth stimulation. Importantly, these proteins are characterized by high biocompatibility and biodegradability.

The new recombinant hybrid proteins represent innovative solutions that demonstrate promising potential and a wide range of applications. They can be used in the creation of new unique bioinks, tissue engineering, regenerative therapies, and as components used in the production of medical devices.

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Projects

3D Bioprinting of a Bionic Pancreas

admin — Thu, 14 Dec 2023 14:24:54 +0000

3D Bioprinting of a Bionic Pancreas

Project: “3D Bioprinting of scaffolds using live pancreatic islets or insulin-producing cells to create a bionic pancreas,” funded by the National Centre for Research and Development under the “Prevention and Treatment of Civilization Diseases” STRATEGMED program.

Implementation period: 01.01.2017 – 30.06.2021.

Total project cost: 24 709 750,00 PLN

NCBR funding: 23 143 024,00 zł

Diabetes is a chronic disease of growing economic and social significance. he number of people with diabetes has tripled in the last 20 years, currently affecting 463 million people worldwide. The World Health Organization (WHO) forecasts that these numbers will double within the next 10 years. As much as 10% of global health expenditures (€646 billion) are allocated to diabetes.

In Poland, approximately 3 million people suffer from diabetes, with 200,000 of them being patients with type 1 diabetes.

Individuals living with type 1 diabetes cannot produce insulin, and their lives depend on daily injections. Although chronic insulin therapy is a solution that allows many people to function, it is a temporary alternative. Insulin therapy does not halt the progression of the disease and does not guarantee the absence of certain complications. The only way to completely cure diabetes is through a whole pancreas or pancreatic islet transplant from a donor. However, in Europe, fewer than 200 pancreas transplants are performed annually (out of approximately 400,000 in need) due to organ shortages. In the case of islet transplantation, the method only provides short-term effectiveness and requires periodic repetitions.

Polbionica aims to address both problems. Our innovative solution is a fully functional, bionic organ printed in 3D using our proprietary bioinks and pancreatic islets, and subsequently, the patient’s own stem cells. Our solution fills the gap between organ shortages and transplantation needs, providing long-term independence from exogenous insulin.

A Tailored Solution

Transplantation of a bionic pancreas will prevent the development of complications in individuals suffering from diabetes. Initially, the bionic pancreas transplant program will target those patients who could potentially qualify for a transplant of a real organ. This group includes individuals with severe complications, in whom a bionic pancreas transplant can realistically halt the onset of secondary complications. Printing a bionic pancreas not only offers the opportunity to save human health and lives but also reduces healthcare expenditures associated with treating diabetic patients. Currently, these expenditures amount to 2.5 billion Polish złoty annually, accounting for 9% of all healthcare expenditures. It’s worth noting that one-fifth of this sum is allocated solely for the treatment of diabetic complications.

As a result of implementing the project, the financial resources needed to treat patients with complications will significantly decrease, along with future costs of immunosuppressive therapy.

Our world’s first bionic pancreas with full vascularization has successfully passed preclinical tests and is ready to demonstrate its effectiveness in clinical trials. The key to our innovation is providing a physiologically appropriate environment for pancreatic islets to ensure they remain healthy and functional. The bionic pancreas can be 3D bioprinted “on demand” and transplanted with minimal risk of complications. It has the potential to change the landscape of treating patients with type 1 diabetes and those with chronic pancreatitis.

Success of Polish Scientists

In March 2019, a multidisciplinary team of scientists from the Foundation for Research and Development of Science, led by Dr. Michał Wszoła, achieved the world’s first bioprinting of a bionic pancreas with a complete vascular system. In the subsequent stage, the bionic pancreas was connected to a special device developed by a team of engineers—a bioreactor—that supplies the printed vascular system with oxygenated fluid and nutrients.

Polbionica, a spin-off company established by the Foundation for Research and Development of Science, leverages its scientific achievements to prepare the bionic pancreas project for the clinical phase and ultimately for commercialization, which will mean its implementation into medical practice in Poland and worldwide.

Our unique project also involved and continues to involve major scientific, medical, and technical institutions. The project was carried out by the BIONIC Consortium, established by the initiative of the Foundation for Research and Development of Science, which includes:

The M. Nencki Institute of Experimental Biology PAN, with the team led by Prof. Agnieszka Dobrzyń
The Faculty of Materials Science and Engineering at Warsaw University of Technology, under the direction of Prof. Wojciecha Święszkowskiego
The Biostructure Center at the Medical University of Warsaw, headed by Prof. Artura Kamińskiego
The MediSpace Medical Center Sp. z o.o.

The BIONIC Consortium received funding for the project titled “3D Bioprinting of scaffolds using live pancreatic islets or insulin-producing cells to create a bionic pancreas” under the STRATEGMED program “Prevention and Treatment of Civilization Diseases”.

The Future Begins Today

We believe that the future of organ printing is now.

Our innovative, fully functional 3D bioprinted bionic pancreas, based on bioprinted scaffolds, functional vessels, and pancreatic islets, is ready for clinical trials. This first-of-its-kind bioprinted organ has the ability to produce insulin, glucagon, and C-peptide. Our technology directly addresses the growing transplantation challenges—organ shortages and the low efficacy of pancreatic islet transplantation.

Our proprietary bioinks provide an appropriate physiological environment and vascularization, ensuring nutrients and proper oxygenation for the pancreatic islets. The vascular system with bioprinting does not require complicated surgery as it is connected to an artery that is 80% smaller than currently used vessels and does not need to be introduced into the abdominal cavity.

We have received a scientific recommendation from the European Medicines Agency (EMA) regarding ATMP classification (EMA/CAT/508907/2020), indicating that the bionic pancreas can be transplanted under the Hospital Exemption Rule and classifying the bionic pancreas as a CATMP.

Further development of organ manufacturing technology would significantly impact public health, largely eliminating the problem of diseases requiring transplantation, reducing treatment costs, the need for social care, and job absenteeism, while improving the quality of life for patients.

The bioprinted bionic pancreas is cheaper than traditional islet transplantation, provides long-term independence from insulin, and eliminates the daily burden of disease management. Our solution is specifically dedicated to patients with complications.

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Projects

3D Bioprinted Liver Tissue

admin — Thu, 14 Dec 2023 14:23:27 +0000

3D Bioprinted Liver Tissue

Project: “3D Bioprinted Liver Tissue with Vascular System as an Innovative Model for Drug Toxicity Assessment and Anti-Cancer Therapy Efficacy,” co-financed by the European Union from the European Regional Development Fund, Operational Programme Intelligent Development 2014-2020. The project is being implemented as part of the National Centre for Research and Development competition 3/1.1.1/2020 Fast Track 3_2020.

Implementation period: 01.07.2021 – 31.12.2023

Total project cost: 24 709 750,00 PLN

EU Funding: 23 143 024,00 PLN

3D Bioprinted Liver Tissue with Vascular System as an Innovative Model for Drug Toxicity and Anticancer Therapy Efficacy Assessment

The aim of the project is to develop innovative bioinks dedicated to the bioprinting of a 3D model of bionic liver tissue, both healthy and cancerous, with a vascular system intended for:

Toxicological tests
Research on the efficacy of new drug candidates

The idea of creating a 3D model for pharmacological research addresses the significant limitations of currently used preclinical research models, both at the in vitro and in vivo stages. The models developed within the project will enable faster and more precise testing of new active substances. They will particularly expedite the assessment of their toxicity and the selection of active substance concentrations.

The proposed solution is a global innovation that will, in the future, significantly reduce or even entirely eliminate the need for preclinical animal testing.

Why 3D Models with Vascular Systems?

Tissue engineering technology is currently one of the fastest-growing interdisciplinary fields of science. Its intensive development is noticeable in regenerative medicine, transplantology, and in preclinical studies of new drug candidates.

One of its main goals is to transition studies conducted on 2D or 3D cell cultures to studies using tissue models that reflect the structure and functionality of native organs, including the vascular system.

At present, the most common model in preclinical studies is the animal model. Despite its widespread use, it has a high failure rate in clinical trials of new drugs. As has been repeatedly shown, animal models are not entirely reliable predictors of the toxicity and efficacy of new active substances for human treatment. It is estimated that 95% of drugs that fail clinical trials had previously passed animal model testing. The primary reason for the withdrawal of tested substances is a lack of efficacy or toxicological properties for human cells and tissues. Therefore, alternative methods for assessing the safety of new drugs are increasingly being considered. The first clear step towards introducing changes was the signing of a bill by the President of the USA at the end of 2022, stating that new drugs do not have to be tested on animals to obtain approval from the U.S. Food and Drug Administration (FDA), provided they were tested using innovative solutions such as tissue bioprinting, organ-on-a-chip, or artificial intelligence modeling.

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Projects

Grants for Eurogrants

admin — Thu, 14 Dec 2023 14:22:41 +0000

Grants for Eurogrants

Project: “Preparation of an application for the Horizon 2020-Accelerator program to develop a unique 3D bioprinting technology for a bionic pancreas” funded by the European Union from the European Regional Development Fund, Operational Program Intelligent Development 2014-2020. The project is implemented as part of a competition by the Polish Agency for Enterprise Development under: Priority Axis 2 Support for the environment and potential of enterprises to conduct R&D&I activities; Action 2.3 Pro-innovative services for enterprises; Sub-action 2.3.6 Grants for Eurogrants. Agreement number: POIR.02.03.06-14-0005/20-00.

Implementation period: 01.06.2020 -31.01.2021.

The main objective of the project implemented under the sub-action is to develop comprehensive and high-quality documentation for Horizon 2020/Accelerator, including an application that consists of the following parts:

Excellence
Impact
Implementation

and the required annexes.

Securing a grant from the Accelerator program will enable the execution of development work and the subsequent commercialization of innovative technology.

The Eurogrant will be allocated to:

Optimization of the production process for bioinks and quality control procedures.
Efforts related to obtaining EMA and FDA approval for performing bionic organ transplants in humans.
Clinical trials concerning the transplantation of a 3D bioprinted bionic pancreas in humans.
Validation of the technology and optimization of the market entry strategy.

The technology developed within the R&D project is crucial for the company’s further development and planned R&D activities.