Abstract
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.
Highlights
Составление нормативной документации (НД) на биомедицинский клеточный продукт (БМКП) — важный этап подготовки документов для его государственной регистрации
The product file (PF) is the main document of a regulatory submission and is used as the basis for biomedical cell product (BCP) quality control
Given the novelty of the Russian legislative framework for innovative products for human use represented by BCPs, the specificity of their composition which differs significantly from conventional medicines, and lack of marketing authorisation experience— there is a need to examine specific aspects of a BCP PF
Summary
В соответствии с пп. 136, 137 приказа Минздрава России от 08.08.2018 No 512н2 НД на БМКП должна содержать в том числе сведения о его составе, описание основного механизма действия, спецификацию на БМКП, показатели качества с критериями приемлемости и методы их определения. 136, 137 приказа Минздрава России от 08.08.2018 No 512н2 НД на БМКП должна содержать в том числе сведения о его составе, описание основного механизма действия, спецификацию на БМКП, показатели качества с критериями приемлемости и методы их определения. Спецификация на БМКП должна включать сведения о качестве готового продукта, которое должно быть подтверждено в ходе проведения экспертизы качества при государственной регистрации. Спецификации на промежуточные продукты производства следует предоставлять в случае осуществления прерывного производственного процесса, например для векторной конструкции при генетической модификации клеток (как в случае с препаратами Kymriah, Yescarta, Zynteglo, Strimvelis21) или КЛ, подвергающейся криоконсервации, в том числе при создании главного и рабочего банков клеток (как в случае препарата Alofisel). Https://www.ema.europa.eu/documents/assessment-report/alofisel-epar-publicassessment-report_en.pdf Приказ Минздрава России от 08.08.2018 No 512н «Об утверждении Правил надлежащей практики по работе с биомедицинскими клеточными продуктами» Определение остаточного содержания гранул, конъюгированных с антителами CD3/CD28, методом микроскопииa Determination of residual beads conjugated with CD3/CD28 antibodies by microscopya
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