We are a team of experienced specialists. We develop innovative therapies for veterinary use that harness the immunomodulatory properties of mesenchymal stem cells. We search for new and effective solutions against common animal diseases.
Bioceltix is a team of experts working on innovative therapies for veterinary use. We work on biopharmaceuticals that harness the immunomodulatory properties of mesenchymal stem cells. We develop them following the highest quality and safety standards. We possess cutting-edge research and production facilities, cooperate with ambitious scientists, and operate under a well-developed business model. Our goal is to market new, effective solutions in the field of veterinary medicine.
The safety and efficacy of Bioceltix products will also be verified through field clinical trials carried out in accordance with Good Clinical Practice (GCP). The independent trials will be conducted in leading veterinary centres, under the supervision of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL). Positive results of the trials confirming the efficacy and safety of the investigational medicinal products will be the basis for their registration in the European Medicines Agency (EMA).
Bioceltix is one of the few companies worldwide to implement the standards of the current Good Manufacturing Practice (cGMP) in the manufacturing of cell-based medicinal products for veterinary use. The cGMP certification confirms that our manufacturing processes meet the highest quality standards required in the manufacturing of pharmaceuticals.
Our technology for manufacturing MSC-based medicinal products for veterinary use utilises the therapeutic potential of allogeneic stem cells (one donor – many recipients). The technology allows the product to be batch-produced and ready for off-the-shelf sale.
Bioceltix is a team of scientists working on innovative therapies in veterinary medicine, supported by top science authorities , leading research entities and experts in the field of commercialisation of scientific research.
Over 500 clinical studies in various phases that seek to examine the use of mesenchymal stem cells (MSCs) in treating numerous diseases are currently underway worldwide. The immunomodulatory properties of MSC serve as a starting point for developing innovative medical therapies for humans. At Bioceltix, we harness the therapeutic potential of MSC to develop innovative biopharmaceuticals for companion animals focusing on areas with high demand for new therapies. The veterinary medicines, based on the immunomodulatory mechanism of action of MSC, will be an alternative to the symptomatic pharmacotherapy focused mainly on alleviating pain and inflammation. Our goal is to create analgesic and anti-inflammatory biopharmaceuticals that will induce the natural mechanisms of regenerating tissues affected by the disease.
A biotechnologist and molecular biologist. An intern at the prestigious Medical College of Georgia (Center of Biotechnology and Genomic Medicine) in the USA. He is completed postgraduate studies in “Management of Research Studies and Development Works”. Previously, he worked at the Ludwik Hirszfeld Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences and the Wrocław Research Centre EIT+. The originator and founder of Bioceltix.
He holds a PhD in biological sciences. He specialises in the visualisation of biological processes at the cellular level. He is an author of multiple scientific publications in prestigious international journals. At Bioceltix, he is responsible for the development and implementation of advanced quality control methods.
Our team is bolstered by experts in the field of veterinary and biological sciences. Their experience and active participation in the company’s business help us identify the best solutions.
PhD, habilitated Aleksandra Klimczak
A professor at the Polish Academy of Sciences (PAN), head of the Independent Stem Cell and Cancer Biology Laboratory of the Ludwik Hirszfeld Institute of Immunology and Experimental Therapy at the Polish Academy of Sciences. Her scientific work includes 79 publications. She specialises in transplantation immunology, regenerative medicine, development of protocols for harvesting stem cells from various tissues and organs, potential clinical applications of stem cells, and others. Through experimental studies on transplantation tolerance to composite (multi-tissue) allografts, she developed methods involving therapeutic adoptive transfer of hematopoietic and mesenchymal stem cells.
PhD, habilitated Arkadiusz Miążek
An associate professor at the Wrocław University of Environmental and Life Sciences (Faculty of Veterinary Medicine, Department of Biochemistry, Toxicology and Pharmacology) and the Ludwik Hirszfeld Institute of Immunology and Experimental Therapy at the Polish Academy of Sciences (IITD PAN) in Wrocław, where he holds the position of the Head of Cancer Immunology Department. He is an author of multiple scientific publications in prestigious, international journals. He specialises in researching T-lymphocytes at the level of gene transcription regulation, intracellular signal transduction, and expression of surface and intracellular markers.
We follow new, global quality standards for manufacturing and developing stem cell-based biopharmaceuticals intended for use in animals. We develop our own solutions – unique ones on a global scale.
Good Manufacturing Practice (GMP) is a set of requirements regarding manufacturing aspects and quality control tests, which in combination with Good Distribution Practice (GDP) and Pharmacovigilance ensures that the manufactured and traded medicinal products are of satisfactory quality and can be safely used in therapy.
Our biopharmaceutical products for veterinary use will comply with the most stringent norms applicable on the market of advanced therapy medicinal products (ATMPs) for human use. We are pioneers in the field of pharmaceutical standardisation of cell therapies for animals and aim to become as one of the first European company to complete the full registration process required by the EMA for veterinary medicinal products that contain mesenchymal stem cells (MSC) as their active pharmaceutical ingredient. Due to the absence of ready registration procedures for stem cell-based medicinal products for veterinary use, we have engaged in an individual dialogue with experts from the ADVENT group (Ad-Hoc Expert Group on Veterinary Novel Therapies) via the Scientific Advice procedure. The consultation with EMA will allow the full registration procedure of our pharmaceutical product candidates to be approved, thus minimising the risk of our marketing authorisation application being rejected. Thus, we are considerably raising the quality bar and set a new standard in the world of veterinary medicine.
At Bioceltix, we rely on our own experience, competencies, top-class equipment, and advanced analytical methods. Our Research and Development Centre is a state-of-the-art infrastructure that allows us to pursue innovative research and implementation projects. We want to ensure that our biopharmaceuticals will meet the highest quality standards, which is why we are building our own cGMP-compliant manufacturing facility.
This allows us to develop and implement stem cell-based biopharmaceuticals for veterinary use, starting from the preliminary research, through prototyping, and finally, to preclinical and clinical efficacy and safety evaluation.
The factors determining Bioceltix’s strength:
We believe that innovative solutions are not created alone. Therefore, we build our ecosystem on the foundation of science and business, obtaining support from recognised and experienced partners. Cooperation with them allows us to develop innovative solutions in veterinary medicine.
Together, we develop and implement accredited methods for determining the eligibility of biological animal-derived material as a starting point for the manufacture of stem cell-based biopharmaceuticals.
Under our cooperation with the Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences (IITD PAN), we are exploring and developing diagnostic tests and targeted anticancer therapies for treating lymphoma and leukemia in dogs. Bioceltix will also be in charge of introducing a fast diagnostic test for detecting autoimmune and inflammatory diseases onto the market of veterinary medicine.
The Clinic has been providing comprehensive veterinary treatment since 1989. This will be the reference centre where the field clinical trial for our first biopharmaceutical will be carried out.
In addition to universities and research institutes, we also invite European veterinary clinics and animal health centres to cooperate with us. We are looking for partners in carrying out clinical trials, training veterinary physicians and introducing our products to everyday veterinary practice. Let’s meet and talk!