scholarly journals Methodological aspects of the development of product files for biomedical cell products

2021 ◽  
Vol 21 (2) ◽  
pp. 122-135
Author(s):  
E. V. Melnikova ◽  
O. A. Rachinskaya ◽  
O. V. Merkulova ◽  
I. S. Semenova ◽  
E. O. Kozhevnikova ◽  
...  
Keyword(s):  
Quality Control ◽  
Cell Line ◽  
Marketing Authorisation ◽  
Test Methods ◽  
Quality Characteristics ◽  
Federal Law ◽  
Test Procedures ◽  
Regulatory Submissions ◽  
Legislative Framework ◽  
Cell Banks

Preparation of a product file (PF) for a biomedical cell product (BCP) is an important stage in the preparation of documents for marketing authorisation. The PF is the main document of a regulatory submission and is used as the basis for BCP quality control. The requirements for the content of a PF, including appropriate specifications, are laid out in the relevant laws and regulations that support Federal Law No. 180-FZ “On Biomedical Cell Products” of 23.06.2016. However, given the novelty of the Russian legislative framework for innovative products for human use represented by BCPs, the specificity of their composition (i.e., components based on viable human cells) which differs significantly from conventional medicines, and lack of marketing authorisation experience— there is a need to examine specific aspects of a BCP PF. The aim of the study was to formulate methodological approaches to the development and preparation of a BCP PF in accordance with the national legislation and taking into account the experience of foreign regulatory authorities in evaluation of regulatory submissions for BCP analogues. The paper summarises the national regulatory requirements for the description of quality characteristics of cell lines used as components in BCPs, as well as test methods and test procedures used for cell line quality control. These data are required both for quality control of BCP samples, and for preparation of the Expert Commission Conclusion. The paper looks into the content of cellular and process-related impurities in a cell line and a finished BCP, and presents considerations on the description of the viral safety strategy for the finished product and for the cells from the master and working cell banks. The approaches to the presentation of quality characteristics and quality control methods for a finished BCP and for the cell line used in its production could be used by BCP developers for preparation of a PF.

scholarly journals Biomedical Cell Products or High-Tech Drugs?

2019 ◽  
Vol 19 (2) ◽  
pp. 94-98
Author(s):  
V. A. Merkulov ◽  
E. V. Melnikova
Keyword(s):  
Clinical Studies ◽  
Marketing Authorisation ◽  
National Level ◽  
Human Cells ◽  
High Tech ◽  
Medicinal Products ◽  
Federal Law ◽  
Advanced Therapy ◽  
Legislative Framework ◽  
Legal Frameworks

Marketing authorisation is a prerequisite for the use of drugs in medical practice in the Russian Federation. The marketing authorisation procedure is applicable to ordinary medicinal products. As for advanced therapy medicinal products containing viable human cells — there are currently two authorisations pathways: athorisation of biomedical cell products (BCPs) at the national level according to the Federal Law No. 180-FZ «On biomedical cell products», and authorisation of high-technology drugs (HTDs) in the Eurasian Economic Union (EEU). The production, pre-clinical and clinical studies, expert evaluation and marketing authorisation procedures are regulated by different legal acts and differ significantly. The aim of the study was to perform comparative analysis of concepts, terms, production process requirements, designs of pre-clinical and clinical studies, and the marketing authorisation procedures for BCPs as defined in the Russian and EEU legislation. It should be noted that both the Federal Law No. 180-FZ and the EEU legislative framework are not currently used due to the lack of such drugs (somatic cell-based BCPs or HTDs). Therefore, at present, the choice of the procedure of obtaining marketing authorisation for drugs containing viable human cells has to be made by the manufacturer, until the Russian and EEU legal frameworks become harmonised.

Animal Models and Alternatives in the Quality Control of Vaccines: Are In Vitro Methods or In Vivo Methods the Scientific Equivalent of the Emperor's New Clothes?

1995 ◽  
Vol 23 (1) ◽  
pp. 61-73
Author(s):  
Coenraad Hendriksen ◽  
Johan van der Gun
Keyword(s):  
Quality Control ◽  
Test Methods ◽  
In Vitro Test ◽  
Large Numbers ◽  
Alternative Approach ◽  
Inactivated Vaccines ◽  
Vitro Test

In the quality control of vaccine batches, the potency testing of inactivated vaccines is one of the areas requiring very large numbers of animals, which usually suffer significant distress as a result of the experimental procedures employed. This article deals with the potency testing of diphtheria and tetanus toxoids, two vaccines which are used extensively throughout the world. The relevance of the potency test prescribed by the European Pharmacopoeia monographs is questioned. The validity of the potency test as a model for the human response, the ability of the test to be standardised, and the relevance of the test in relation to the quality of the product are discussed. It is concluded that the potency test has only limited predictive value for the antitoxin responses to be expected in recipients of these toxoids. An alternative approach for estimating the potency of toxoid batches is discussed, in which a distinction is made between estimation of the immunogenic potency of the first few batches obtained from a seed lot and monitoring the consistency of the quality of subsequent batches. The use of animals is limited to the first few batches. Monitoring the consistency of the quality of subsequent batches is based on in vitro test methods. Factors which hamper the introduction and acceptance of the alternative approach are considered. Finally, proposals are made for replacement, reduction and/or refinement (the Three Rs) in the use of animals in the routine potency testing of toxoids.

scholarly journals Quality characteristics of spatial furniture

2009 ◽  
pp. 135-145 ◽  
Author(s):  
Dusan Skakic ◽  
Igor Dzincic
Keyword(s):  
Quality Control ◽  
Quality Characteristics ◽  
High Quality ◽  
Production Economy ◽  
Production Practice ◽  
Basic Quality ◽  
Quality Of Products ◽  
Quality Production

The quality of products represents one of the key aims of any modern organized production. In the production practice, it is essential to establish the optimal relationship between quality, production economy and delivery deadlines. Furniture quality is evaluated by three levels and they are: basic quality, high quality and especially high quality. The results presented in this paper are based on the sample measurements of chairs and tables during 2007 and 2008 at the Institute for Furniture Quality Control.

scholarly journals Overview of test methods to determine strength and plastic properties of the wire

2018 ◽  
pp. 67-70
Author(s):  
M. A. Kukharenko ◽  
V. A. Mokhoreva
Keyword(s):  
Yield Strength ◽  
Length Change ◽  
Test Methods ◽  
Quality Characteristics ◽  
Thin Wire ◽  
Plastic Properties ◽  
Management Company ◽  
The Wire ◽  
Dial Indicator

The article presents various methods for determining the strength and plastic properties of the wire to assess the quality characteristics of the products produced in the steel shops of JSC «BMW – the Management Company of the Holding «BMC».The methods of determining the propensity of a thin wire to laminations by reversing the twisting («Swedish» twist) and unilateral twisting, fixing the length change of the sample with a prefix with the dial indicator are considered. The article describes the procedure and results of research to determine the effect of the ratio of the conditional yield strength to the time resistance of the rupture on the plastic properties of the wire, the type of tensile diagram of the wire fragility.

scholarly journals Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing

2020 ◽  
Author(s):  
Unai Perpiña ◽  
Cristina Herranz ◽  
Raquel Martin-Ibañez ◽  
Anna Boronat ◽  
Felipe Chiappe ◽  
...  
Keyword(s):  
Cell Line ◽  
Cell Lines ◽  
Hek293t Cell ◽  
Good Manufacturing Practice ◽  
Clinical Grade ◽  
Cell Bank ◽  
Advanced Therapy ◽  
Working Cell ◽  
Cell Banks ◽  
Hek293t Cell Line

Abstract Background: Cell banks are widely used to preserve cell properties as well as to record and control the use of cell lines in biomedical research. The generation of cell banks for the manufacturing of Advanced Therapy Medicinal Products, such as cell and gene therapy products, must comply with current Good Manufacturing Practice regulations. The quality of the cell lines used as starting materials in viral-vector manufacturing processes must be also assessed.Methods: Three batches of a Master Cell Bank and a Working Cell Bank of the HEK293T cell line were manufactured under current Good Manufacturing Practices regulations. Quality control tests were performed according to product specifications. Process validation includes the training of manufacturing personnel by performing simulation tests, and the continuous measurement of environmental parameters such as air particles and microorganisms. Cell number and viability of cryopreserved cells were periodically measured in order to define the stability of these cellular products.Results: All batches of HEK293T Master and Working Cell Banks met the acceptance criteria of their specifications showing the robustness and homogeneity of the processes. In addition, both Master and Working Cell Banks maintained the defined cell viability and concentration over a 37 month-period after cryopreservation. Conclusions: Manufacturing cell banks under Good Manufacturing Practice regulations for their use as raw materials or final cellular products is feasible. HEK293T cell banks were used to manufacture clinical-grade lentiviral particles for Chimeric Antigen Receptor T-cell based clinical trials.

Study on Quality Control Method in Multi-Specification and Small-Batch Production

2014 ◽  
Vol 1006-1007 ◽  
pp. 363-366
Author(s):  
Hai Dong ◽  
Qing Quan Tong ◽  
Yi Kai Wang
Keyword(s):  
Quality Control ◽  
Process Control ◽  
Control Chart ◽  
Control Method ◽  
Quality Characteristics ◽  
Batch Production ◽  
Factors Affecting ◽  
Quality Control Method ◽  
Element Theory

Aiming at the problem of less quality characteristics data in multi-specification and small-batch production, matter-element theory was applied to adjust similarity of factors affecting the quality during the processing, thus similar processes was divided and data shortage problem was resolved. In addition, the relative range method was applied to translate characteristics data, thus drawing the control chart to judge process control state.Through the analysis of a case,the validity of quality control method was verified in the multi-specification and small-batch production.

The issues of controlling the use of chemical reagents to ensure the safety and efficiency of oil production, treatment and transportation

2021 ◽  
pp. 338-345
Author(s):  
Ильназ Ильфарович Хасбиуллин ◽  
Антон Анатольевич Шматков
Keyword(s):  
Quality Control ◽  
State Level ◽  
Oil Production ◽  
Oil Industry ◽  
Legal Regulation ◽  
Test Methods ◽  
Regulation System ◽  
Pipeline Transportation ◽  
Technical Regulation ◽  
Chemical Reagents

Химические реагенты активно используются в нефтяной отрасли для решения практических задач и совершенствования технологических процессов. При этом на сегодняшний день в России не определен единый, регламентированный нормативно-правовым документом надлежащей юридической силы, порядок применения и контроля качества химических реагентов при добыче, сборе, подготовке и трубопроводном транспорте нефти. С целью обоснования необходимости совершенствования технического регулирования в указанной области проведен анализ нормативно-правовой базы, требований к данному виду химической продукции, процедуры ее сертификации, правил и порядка допуска к применению. Установлено, что в настоящее время использование химических реагентов в нефтяной отрасли почти в полной мере регулируется внутренними нормативными документами компаний - потребителей этих химических веществ, что имеет издержки и недостаточно для эффективного функционирования системы технического регулирования в рассматриваемой области. Представляется целесообразным вернуться к ранее существовавшей практике общего нормативно-правового регулирования применения химических реагентов в процессах добычи, сбора, подготовки и трубопроводного транспорта нефти, а также обязательной сертификации данного вида продукции. Необходимо продолжать деятельность по обеспечению эффективности и безопасности применения химических реагентов: совершенствовать нормативную базу и систему контроля качества, разрабатывать новые методики испытаний и инструкции по применению. Все эти меры должны реализовываться не только на отраслевом, но и на государственном уровне. Chemical reagents are actively used in the oil industry to solve practical problems and improve processes. At the same time, Russia currently has no unified procedure for the use and quality control of chemical reagents in the production, collection, preparation, and pipeline transportation of oil that is regulated by a legal document of proper legal force. In order to substantiate the need to improve technical regulation in this sphere, analysis of the regulatory and legal framework, the requirements established for this type of chemical product, the procedure for its certification, rules and procedures for admission to use has been conducted. It has been established that currently the use of chemical reagents in the oil industry is almost fully regulated by the internal regulatory documents of companies that consume these chemicals, which incurs costs and is insufficient for the effective functioning of the technical regulation system in the industry under consideration. It seems appropriate to return to the previously existing practice of full legal regulation of the use of chemical reagents in the processes of oil production, collection, preparation, and pipeline transportation, as well as mandatory certification for this type of product. It is necessary to continue activities to ensure efficiency and safety of the chemical reagent use: to improve the regulatory framework and quality control system, to develop new test methods and usage instructions. All these measures need to be implemented not only at the industry but also at the state level.

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