On November 16-17, 2023, the scientific forum KyivLvivPharma-2023 was held in Lviv, which was dedicated to pharmaceutical technologies for ensuring human longevity. Nelya KYSHYNETS, a senior researcher of the Department of the State Pharmacopoeia of Ukraine at the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines, took part in the event.
As part of the scientific and practical conference, many interesting reports were presented, dedicated, in particular, to achievements in the field of R&D, discussion of global trends to improve the quality of life, application of the principles of "green chemistry", cosmetics, cell therapy, prospects for the creation of antibiotics and their use in medical practice, modern methods of decontamination of chemical weapon components and developments in the creation of means for the wound treatment, rehabilitation and patient care. A panel discussion on Frugal pharmaceutical production and its compatibility with GMP was also held, in which experts from leading domestic pharmaceutical companies took part. The event gathered scientists and representatives of Ukrainian pharmaceutical enterprises.
Nelya KYSHYNETS, head of the scientific areas of the State Pharmacopoeia of Ukraine (SPhU) on Biological Methods of Analysis, Monographs and General Texts on Biological Medicinal Products, Statistical Analysis of Biological Test Results and Assays, expert of the working group CTP – Cell Therapy Products of the European Pharmacopoeia, presented a report on ensuring the standard of preparation and quality control of mesenchymal stem cells in accordance with the requirements of the SPhU. Mesenchymal stem cells are undifferentiated cells present in various body tissues with significant potential in regenerative medicine due to their ability to self-renew and differentiate into tissue-specific cells such as osteoblasts, chondrocytes, and adipocytes. Most often, they are isolated from bone marrow and adipose tissue. Mesenchymal stem cells produce secretory factors critical in tissue regeneration and support engraftment and trophic function (autocrine and paracrine). They also regulate tissue development and support repair and are beneficial in a range of clinical conditions. Mesenchymal stem cells can be autologous (from the recipient) or allogeneic (from the donor). The selection of donors is carried out in accordance with the criteria set forth in Directive 2004/23/EC of March 31, 2004. The use of mesenchymal stem cells is promising in relation to angiogenic therapy for the treatment of patients with ischemic and neurodegenerative diseases, wound healing, and treatment of tissue and organ fibrosis. That is why research in this direction is currently very relevant, with specialists from all over the world participating in these works.
We would like to emphasize that the high professionalism of our team, as well as close cooperation with the pharmaceutical industry, official quality control laboratories, leading world pharmacopoeias and organizations, and academic circles allows our center to participate in prospective standardization, i.e. identifying and solving new problems before they become widespread. Thus, the State Pharmacopoeia of Ukraine (SPhU) was the first among pharmacopoeias to issue national monographs devoted to mesenchymal stem cells for human and veterinary use (SPhU 2.6). These texts were presented by the delegate of Ukraine at the 175th session of the European Pharmacopoeia Commission and attracted the attention of the European Pharmacopoeia, which invited a specialist of the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines to join the relevant working group. That's how Nelya Kyshynets became an expert of the European Pharmacopoeia’s working group on Cell Therapy Products.
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