Validation of biological activity testing procedure of recombinant human interleukin-7

Lutsenko, Tetiana; Kovalenko, Mykola; Galkin, A. Yu.

doi:10.15407/ubj89.01.082

Cited by 15 publications

(21 citation statements)

References 2 publications

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“…Biological activity was evaluated in compari son to the standard sample of rIL-7 (calibrator) produced by PeproTech (Rocky Hill, NJ, USA), which allowed the calculated content of the test cytokine in the preparation sample. Validation of this method as a method of quantitative determination was carried out previously [22].…”

Section: Resultsmentioning

confidence: 99%

“…The cytokine was purified from impurities via usage of gel filtration on Sephadex G-25 and ion-exchange chromatography on Q and SP Sepharose (Merck, USA). Control of purity of the preparation was performed via polyacrylamide gel electrophoresis with sodium dodecyl sulfate (SDS-PAGE), and biological activity was determined by means of mononuclear peripheral blood cells (MPBC) from healthy donors (cell proliferation evaluation was performed using 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazole bromide -MTT-test) [22]. In this study, rIL-7 preparations at concentrations of 20 μg/ml were used.…”

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confidence: 99%

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Effect of recombinant human interleukin-7 on Pseudomonas aeruginosa wound infection

Grigorieva¹,

Starosyla²,

Рыбалко³

et al. 2019

Ukr.Biochem.J.

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A wide range of interleukin-7 (IL-7) biological effects suggests that application of appropriate preparations in clinical practice will stimulate immunity in patients with lymphocytic exhaustion or autoimmune diseases. Studies are being conducted for Il-7 based preparations aimed at restoration of the immune system of patients with immunodeficiency of different origins. Pseudomonas aeruginosa is an important pathogen, which causes nosocomial infections in hospitalized patients. Infection factors, affecting the immune status of the host, play a key role. A promising and relevant scientific endeavor is the study of the effect of recombinant as an adjunct therapy in wound infections caused by P. aeruginosa. the aim of this study was to evaluate the effectiveness of rIL-7 use in P. aeruginosa wound infection in mice. The experiments were conducted using a standardized rIl-7 preparation, P. aeruginosa strain and 20 white non-inbred mice. the preparation of rIL-7 after all stages of purification was characterized by the content of ballast proteins and impurities via electrophoresis in a polyacrylamide gel in reducing conditions, and its biological activity was evaluated in the Mtt test by means of proliferation of peripheral blood mononuclear cells. In the mice, the fur was removed, the neck nape was intentionally injured and P. aeruginosa bacteria were injected into the wound of each animal (0.1 ml of suspension with a bacterial cell concentration of 0.08×10 9 cells/ml). Starting from the 2 nd day, bacterial examination of the wound material was carried out daily. Starting from the 3 rd day, the mice (experimental group, n = 10) were intraperitoneally administered 5 μg (0.1 ml) of the rIL-7 preparation. In the control group of animals (n = 10), the rIl-7 preparation was not administered. In 80% of experimental animals (administered the rIl-7 preparation), the healing of wounds and elimination of the pathogen of purulent inflammatory infection P. aeruginosa occurred on the 7 th day. on the 9th day from the beginning of wound infection, wound healing and elimination of P. aeruginosa occurred in all experimental mice. In 60% of mice from the control group (did not receive treatment with rIl-7), wound healing and the elimination of P. aeruginosa occurred on the 9th day. Wound healing and elimination of P. aeruginosa in all mice of the control group occurred on the 14th day. thus, in mice treated with rIl-7, wound healing and elimination of the pathogen occurred 5 days earlier than in mice from the control group . Subsequent studies may be aimed at developing protocols for the treatment of wound infections using an rIl-7 preparation in patients with a compromised immune system therefore, rIl-7 is a promising preparation for the treatment of complex wound infections. k e y w o r d s: recombinant human interleukin-7, Pseudomonas aeruginosa, wound infection, therapy.

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Section: Resultsmentioning

confidence: 99%

mentioning

confidence: 99%

Effect of recombinant human interleukin-7 on Pseudomonas aeruginosa wound infection

Grigorieva¹,

Starosyla²,

Рыбалко³

et al. 2019

Ukr.Biochem.J.

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“…At previous study steps, we have scientifically justified composition and technology of the product based on recombinant human IL-7 in the form of nasal spray (drops); quality profile of such product [6,7], its biological (specific) standardization methods have been developed [8,9].…”

Section: Abstract: Antimicrobial Activity Microbiological Purmentioning

confidence: 99%

Development of the method for microbiological purity testing of recombinant human interleukin-7-based product

Galkin¹,

Lutsenko²,

Gorshunov³

et al. 2017

Ukr.Biochem.J.

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“…На попередніх етапах нами було обґрунтовано склад і технологію отримання препарату у формі назального спрея (крапель) [5,6], а також роз-роблено підходи до біологічної стандартизації продукції [7,8].…”

Section: вступunclassified

Risk Assessment of Technology of Preparation Based on Recombinant Human Interleukin-7 and Its Perspective Validation

Lutsenko¹,

Motronenko²,

Gorshunov³

et al. 2017

Research Bulletin of the National Technical University of Ukraine "Kyiv Politechnic Institute"

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Background. Quality management is a very important activity of any industrial enterprise, especially when it comes to manufacturing products in health care (drugs, including medical immunobiological preparations, medical devices, cosmetics, dietary supplements, etc.). Risk-oriented thinking enables an organization to identify factors that may cause rejection of its processes and its quality management system for planned results to establish preventive controls to minimize negative impacts and the greatest possible shaft advantage of the opportunities as they arise. The logical continuation of the risk assessment is validation processes. This article is a fragment of the complex scientific and technical work on the development and standardization of biotechnology products based on recombinant human interleukin-7 (rhIL-7). Objective. Justification for approaches to risk assessment in the technology for getting preparation based on rhIL-7 in the form of nasal spray and particularly risk assessment of the production process, and perspective validation of developed technologies. Methods. The methodology of risk assessment according to ISO 14971:2009 "Medical devices. Guidelines for risk management" was used. Pharmacopoeial methods were used to control the process and product quality (potentiometric determination of pH, osmolality, sterility). The integrity of the filters was determined by the method according to the manometer producer. Results. The work consistently study approaches to risk assessment in the technology for getting preparation based on rhIL-7 in the form of nasal spray and particularly risk assessment of the production process, and the validation of promising technologies developed. Selection of guidelines on risk assessment was conducted for Guidelines for Good Manufacturing Practices, ISO 9001:2015, ISO 13485:2005, and ISO 14971:2009. The greater acceptability of the use of the past two standards was showed. Technological production scheme is presented and qualitative approach to analyze the identified risks is applied. For the most critical stage of production (preparation of sterile solution) the validation process is conducted. Conclusions. The feasibility of risk assessment in the technology for getting preparation based on rhIL-7 in the form of nasal spray according to ISO 14971:2009 together with the system using risk analysis and critical control points is theoretically justified. It was found that the most critical step in the production is part of the preparation of a sterile solution, which includes the preparation of intermediate filtering and sterilizing drug. The conducted prospective validation of the most critical stages of the technology demonstrated its stability and compliance with established eligibility criteria.

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Validation of biological activity testing procedure of recombinant human interleukin-7

Abstract: Validation procedure for method of monitoring the biological activity of reсombinant human interleu-

Cited by 15 publications

References 2 publications

Effect of recombinant human interleukin-7 on Pseudomonas aeruginosa wound infection

Effect of recombinant human interleukin-7 on Pseudomonas aeruginosa wound infection

Development of the method for microbiological purity testing of recombinant human interleukin-7-based product

Risk Assessment of Technology of Preparation Based on Recombinant Human Interleukin-7 and Its Perspective Validation

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