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

Abstract

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.