Who are we?

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.

 

bio-tech

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.

Our Team

Leaders

Łukasz Bzdzion President of the Management Board

Paweł Wielgus Member of the Management Board

Andrij Włach CFO, Proxy

Grzegorz Ostropolski Chief Operating Officer

 

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.

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An investor, a scientist, a practitioner. A managing partner at Kvarko Group, a technology venture capital fund. An expert on the commercialization of intellectual property.

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A managing partner at the Kvarko Group, a high-risk technology investment fund. An expert in the field of intellectual property rights valuation and planning of start-up companies.

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Partner for operational management, process optimization and drive of projects. He gained experience in international corporations creating new manufacturing organizations and implemented new products into global markets. A graduate of the University of Economics and postgraduate of Quality Management at University of Technology in Wrocław.

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R&D Team

Phd Jakub Grzesiak Director of Technology

Karol Wrzeszcz Quality Assurance Manager

Phd Andrzej Kowalczyk Quality Control Manager

Elżbieta Gocek Research and Development Manager

Paweł Pytel Quality Control Specialist

Maria Woldan Quality Control Specialist

Phd Justyna Roszkowiak R&D specialist

Marta Pasikowska Clinical Research Coordinator

Krzysztof Wiśnicki Production operator

Barbara Kucharska Quality Control Specialist

Łukasz Świderski R&D specialist

Katarzyna Wróblewska Quality Assurance Specialist

Natalia Mika Production manager

Phd Patryk Reniewicz Senior R&D Specialist

Michał Harasymowicz Maintenance specialist

 

A biologist, he holds a PhD in veterinary sciences. He is an expert in stem cell biology and electron microscopy. An author of over 40 research papers. At Bioceltix, he is in charge of supervising key research and development works.

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He is a cellular biologist specialising in cell culture and microscopy. At Bioceltix, he is involved in developing new technology concepts, technological routes and quality control methods. Responsible for the operation of the Pharmaceutical Quality System and GMP quality assurance.

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Ph.D. in Veterinary Science, biotechnologist. Molecular Diagnosis Methods Specialist, with experience in virology and the ISO laboratory quality management system. Quality Control Manager in Bioceltix.

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PhD in biological sciences, specializing in biochemistry, co-author of over 20 scientific publications. Elżbieta completed postdoctoral fellowships at Rutgers, New Jersey Medical School (USA) and at Ben Gurion University of the Negev (Israel). She has over ten years of experience in managing the work of laboratories, carrying out research projects and cooperating with key biotechnology companies in Poland.

At Bioceltix responsible for implementing and developing new research techniques.

 

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Molecular microbiologist with experience in the preparation and purification of monoclonal antibodies. At Bioceltix  he supports research and development department.

 

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Microbiologist with a work experience in molecular biology, clinical microbiology and cytology. Responsible for quality control research as well as supporting activities involving research and development at Bioceltix.

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PhD in field of biology in immunology and microbiology specailization, experienced in pathogen-host interactions. At Bioceltix, she is an R&D specialist,  engaged in the development and implementation of new research methods and development projects. 

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Veterinary surgeon whose clinical focus is dentistry and oral surgery. At Bioceltix involved in the supervision of clinical trials for medicinal products.

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A graduate of the University of Agriculture in Krakow, with experience in large biopharmaceutical companies.

Specializes in the cultivation of mammalian cells.

At Bioceltix as a manufacturing member responsible for supporting R&D projects.

 

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Biotechnologist with experience acquired in a biopharmaceutical company developing biological drugs and non-systemic therapies. Trained in molecular biology during studies at the Wrocław University of Science and Technology and scientific internship at the Institute of Immunology and Experimental Therapy PAS. Responsible for quality control as well as supporting activities involving research and development at Bioceltix

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A graduate of University of Science and Technology in Wroclaw, with experience in phage display selections of antibodies. At Bioceltix, as a R&D specialist, he deals with the development and implementation of new research methods and development projects.

 

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Wrocław Medical University  graduate, laboratory scientist specializing in transfusion medicine.  Was a member of an international research team at King's College London.

For over 10 years has been working in the area of quality assurance in accordance with the requirements of Good Manufacturing Practice. At Bioceltix responsible for maintaining and developing the pharmaceutical quality system.

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Master in Microbiology and Veterinary Techniques with experience in Molecular Biology and Clinical Microbiology.
At Bioceltix, as a member of the production team responsible for support in research and development projects.

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Patryk is a PhD with a specialization in the field of virology with width knowledge of immunology and molecular biology. He has expertise in genome manipulation techniques such as CRISPR. At Bioceltix, as a R&D specialist, he deals with the development and implementation of new research methods and development projects.

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Graduate of Wrocław University of Science and Technology. Previously worked for variuos international manufacturing plants.

In Bioceltix Michał is responsible for oversight of production warehouse, IQ/OQ/PQ qualification and devices maintenance.

 

 
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Project Team

Bartłomiej Żarłok Supplier specialist

Anna Maria Olko-Chudy Board Assistant & office coordinator

Żaneta Olszewska Senior controlling specialist

Joanna Bzdzion Administration specialist

 

A graduate of the Faculty of Chemistry at the Wrocław University of Technology with experience in medical and biopharmaceutical companies. At Bioceltix responsible for company's purchasing area and laboratory supplies.

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There is no such thing that she will not take care of.  With commitment and smile. She gained experience managing the office of the head of one of the law enforcement services. Graduated from Social Pedagogy and Safety Management at University of Lower Silesia. She loves animals, sorts garbage and hates food-wasting.

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Controlling specialist with experience in implementation of projects co-financed from European funds and in the Human Resources Department. A graduate of the University of Wrocław and the WSB University in Wrocław in the field of Finance and Accounting. At Bioceltix  responsible for supervision of the company's finances.

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An administration specialist with experience in working in international corporations. A graduate of the University of Wrocław. Certified ICF trainer. At Bioceltix responsible for HR, recruitment and development processes.

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Bioceltix zespółBioceltix zespół

The Scientific Board

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.

DVM PhD, Maciej Przewoźny

Graduate of the Faculty of the Veterinary Medicine at Wrocław University of Environmental and Life Sciences. In 2004 he defended his doctoral dissertation: “The use of acute-phase proteins in post-surgery monitoring of horses”, based on the study of horses after arthroscopic surgeries. Following an internship in Germany, he obtained the title of Fachtierarzt für Pferde. In 2008 he completed a veterinary chiropractic course provided by American and German experts from the IAVC/IVCA. In recent years he has also completed numerous other internships and courses, mainly abroad. He specialises in orthopaedics and sports medicine. He was several times involved as a doctor for the show jumping national team at the European and World Show Jumping Championships.

Quality and safety

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.

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Research facilities

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:

  • our team of highly qualified scientists, whose wide array of competencies includes such disciplines as biotechnology, cellular biology, molecular biology, immunology, and pharmacy;
  • a multidisciplinary team of managers experienced in project management, commercialisation of intellectual property and economics;
  • the combination of expertise and experience, as well as cutting-edge research and development infrastructure, has resulted in the formation of an innovative company, which turns the latest biomedical knowledge into new generation of pharmaceuticals.

Our Partners

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.

 

Wroclaw Business Park - Bierutowska Park

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.

www.wroclawskieparkibiznesu.pl

Ludwik Hirszfeld Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences (IITD PAN) in Wrocław

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.

www.iitd.pan.wroc.pl

Vetriver Klinika Weterynaryjna (Veterinary Clinic) Andrzej Małkowski

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.

www.vetriver.pl

Join us!

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!

ekosystem@bioceltix.com