On August 22, in Ufa, at the site of the 9th Pan-Russian GMP Conference with international engagement, a panel session dedicated to the production of biological medicinal products will be held. Experts will focus on issues surrounding the definition of advanced therapy medicinal products and biomedical cell products. Leading pharmaceutical manufacturers in Russia will share best practices in the development and production of blood products. 

In current Russian pharmaceutical practice, the term “advanced therapy medicinal products” (ATMP) has been increasingly used along with biomedical cell products (BCP) in recent years. According to the EU and EAEU practice, this category includes gene therapy medicinal products, somatic cell therapy medicinal products, tissue-engineered products.

Does it mean that ATMP is a broader concept including BCP, which contain living human or animal cells? Where is the watershed between ATMP and BCP? These are the questions for experts of the session “Features of the Production of Biological Medicinal Products” to find answers to. Participants will also discuss key aspects of quality assurance for these two product categories.

It bears reminding that this year the working group of the EAGP Expert Council has completed work on preparing the Russian-language text of Part IV of the GMP Guidelines, which presents the requirements for the production of advanced therapy medicinal products.

In addition to ATMP and BCP, during the session, Russian pharmaceutical manufacturers experience in development, investigation and production of blood products will be presented. Today in Russia manufacturers developing complex blood products, immunoglobulins or hemostatic products are not that many. One of them is Pharmstandard, the general partner of the IX GMP Conference. Pharmstandard-UfaVITA OJSC (the company’s site in Ufa) manufactures Coagulation factor VIII. Production was launched at the end of 2022, and in June of this year, the company entered into an agreement with the Moscow mayor’s office to create Russia’s first manufacturing plant for main plasma-derived medicinal products facilitating improvement in quality and increase in life expectancy of patients with severe and chronic diseases.

Blood product manufacturing is an intensively developing area of ​​the pharmaceutical industry and one of the strategically important government tasks in the field of healthcare. According to “National Health Development Fund”, more than 1 million Russians need albumin and immunoglobulin annually. However, only 14 plasma centers throughout the country accept plasma donors, which is used exclusively for the manufacture of medicinal products, and manufacture of plasma-derived medicinal products on average takes about a year from the moment of donation.

In addition, ATMP, BCP and blood products are integral components of personalized medicine. Therefore, close attention is paid to their production.

We invite you to learn how to augment production potential of this category of medicinal products, taking into account current requirements of relevant regulatory authorities, at the session “Features of the Production of Biological Medicinal Products” sponsored by Pharmstandard JSC, which will be held on August 22 at 11:15.