Are global trends in the use of AI and digital technologies relevant in Russia, how are Russian pharmaceutical manufacturers involved in the process of implementing new production technologies and other industry issues

The session was moderated by Irina Novikova , CEO of GxPnews. As the expert said in her opening remarks, “in the next 10 years, we will see 50 drugs developed with the help of AI on the market, which also helps to reduce costs and expenses by up to 40%.

Olga Kravtsova , Deputy Director of the Department for Development of the Pharmaceutical and Medical Industry, Ministry of Industry and Trade of the Russian Federation, spoke at the session : “The path of AI implementation in the Russian pharmaceutical industry is its own and individual. In general, pharma really depends on new technologies, IT allows us to move into the future by leaps and bounds. The pharmaceutical industry is science-intensive and technological, the level of technological maturity of companies today is really high. I would like to draw special attention to the fact that since 2010, 77 new production sites have been launched in the Russian Federation, created within the framework of modern requirements. There are 548 licensees operating, and almost all regions of the country produce medicines. Companies understand the importance of investing in developments.”

Olga Kravtsova also added: "As for the digitalization of the pharmaceutical industry, this process should be divided into several areas. These are electronic assistants, project systems, accounting, which affect the acceleration of logistics. The second is the issue of equipment (automation of the production cycle), including laboratory equipment, and in addition, the availability of systems and platforms for scientific research for the purpose of developing drugs (collection, processing and analysis of information)." However, as the speaker noted, robotics and automation do not cancel the issue of confirming the quality and safety of products .

Next, Vladislav Nikolaevich Shestakov , Director of the Federal State Budgetary Institution “State Institute of Drugs and Non-Profit Partnership of the Ministry of Industry and Trade of the Russian Federation”, took the floor online : “One of the priorities of the “Pharma 2030 Strategy” is the active development of technologies. During inspections, we see drugs using nanotechnology, and in the future, it is also expected that drugs will be created using 3D printing. In this regard, there is a need for new inspection practices and continuous improvement of inspectors’ knowledge. In order to issue a qualified assessment, inspectors improve their qualifications in various fields. We know of a successful example of the introduction of new mechanisms at production sites – chromatographic methods. New technologies do allow us to improve production processes, but they can pose potential risks to patients. And one of the measures to reduce these risks is inspection and production control.”

Viktor Aleksandrovich Dmitriev , General Director of ARFP, spoke at the session : “The use of AI carries risks that should also be taken into account. Firstly, in the technological direction: if a failure occurs in the system, it is important to understand how to proceed. Secondly, when implementing a labeling system. If the technology fails, even if there is an error in one letter, the system stops reading the company. And the human factor is also extremely important - whether the data was entered on time, and so on. In this regard, the issue of training personnel arises, both for production and regulation. It is necessary to adjust the regulatory framework.”

In his speech, the expert also highlighted the forecasts for the industry and emphasized the importance of the availability of new technologies. "It is necessary to understand in whose hands the technology will be, what the threat of its incorrect use may be." And finally, the issue of responsibility. The speaker stated: the regulatory framework is extremely important. At the same time, as Viktor Dmitriev said, the patient should be at the forefront, and any new technology is good if it helps and does not harm.

Dmitry Borisov , CEO of NTFF POLYSAN LLC: “First of all, I will talk about the use of AI and the development of the drug. The main technology used in this process is working with big data. The requirements for development have become much stricter over the past 15 years. Today, we have different conditions, research, a drug dossier is about 600-700 sheets. In our company, the stability center occupies two floors, these are dozens of small and two stationary chambers.” As the expert stated, all developments undergo a thorough stability analysis, and for the process to be effective, all data must be structured, which is what AI does.

Dmitry Borisov also discussed the use of AI in drug production: "AI offers endless potential and opportunities. Today, there are fewer and fewer highly qualified personnel, and the industry is always in short supply in this regard. It is worth noting the great contribution of the regulator - the Inspectorate of the Ministry of Industry and Trade, which pays attention to important setup processes, proper storage of finished products and ingredients. The warehouse must be licensed and automated in terms of humidity and temperature parameters, and this is done by large automated systems that allow storing products and raw materials in accordance with requirements."

Yuri Smirnov , Director of ARTLIFE TECHNO LLC, answering a question about changes in orders from pharmaceutical companies, said: “The ERP system in the company integrates all processes at the enterprise, ranks production tasks: workshop loading, availability of components and tools, the system also allows you to track the history of parts manufacturing (end-to-end barcoding system) and much more.”

According to Yuri Smirnov, previously the main emphasis was placed on compliance with GMP requirements. Today, pharmaceutical companies impose high requirements for automation and integration. For example, ARTLIFE TECHNO LLC implemented projects for the development, design support, manufacture and installation of reactor systems equipped with analytical instruments and data collection systems from components. In conclusion, the speaker emphasized: "AI is, first of all, new opportunities, and it is not too early to engage in it."

During the session, Alexey Maksimov , Executive Director, Avrora Plant, presented a report to the audience. According to the report, the trends today include:

// adaptability
// automation
// integration
// eco-friendliness (clean packaging solutions).

Alexey Maksimov cited statistics: the pharmaceutical equipment market reaches 15.62 billion dollars. The average annual growth rate is 8.6%. Trends in the packaging equipment market in the Russian Federation:

// Process automation
// Implementation of innovative technologies
// Multifunctional solutions and flexibility.

In 2023, the production of containers and packaging, according to the speaker, grew by 11%. Trends that determine the future of the industry:

// Growing need for flexible and integrated packaging machines
// Implementation of AI technologies in equipment
// Growing digitalization, optimization of production processes.

The expert also described in detail the possibilities of using Gen AI using the example of the work of the "AVRORA" plant. As the speaker stated, AI-based equipment allows for a 5% increase in productivity, savings in maintenance up to 10%, and savings on capital costs up to 10%.

Next, Nikita Punia , Executive Director of the Pharmasyntez Group of Companies, took the floor : “We have been using automatic systems that check all impurities, inclusions, etc. for over 10 years. I believe that a certain assessment of the work of AI is needed; it is too early to use it in production. Real practice of application does not always correspond to what companies declare. As a rule, long-automated processes are passed off as the use of AI. As for the difficulties of implementing new technologies, there are none. This is rather a question of the key rate on the market and a problem only for new players, while for large players little has changed.”

One of the speakers at the plenary session was Cai Jun , CEO of Sinopharmtech LLC. He emphasized that AI allows us to reduce production costs, environmental impact (reducing the risk of pollution by harmful products), and optimize costs. The specialist also spoke about new technologies and how they lead to significant changes in the industry, namely:

// Modern technologies with biomolecules, rapid drug production, continuous production.
// Closed aseptic filling systems, mechanical manipulators and product packaging systems.
// Design and operation of bioreactors, digital twin technologies in real time.
// Computational Thermodynamics Technologies.
// Solid dispersion and microcapsule technologies.

Anna Yakhutina , Head of Sales Group at Tofflon Rus LLC, in her report covered the topic of the traditional approach to process automation: PLC (including the SCADA method) and DCS (distributed control system). According to the speaker, many companies have already switched to the DCS system.

Anna Yakhutina spoke about process-analytical technology (PAT), the advantage of which is continuous production. The expert emphasized that the combination of IT with operational technologies ensures maximum transparency in a digital enterprise, which allows for meaningful use of data both within the company and outside it. The speaker also noted the importance of cybersecurity in pharmaceutical enterprises.

At the end of the plenary session, Olga Kravtsova made a closing speech : “In general, the discussion results show that the participants agree on many aspects. Pharma has strict regulation, and we, for our part, broadcast where it is worth moving. First of all, this is based on the “Pharma 2030 Strategy”. And finally, I would like to emphasize the issue of expediency. The pharmaceutical industry is self-sufficient and regulated, so there are no strict requirements to implement AI and robotics across the board. However, in order to produce high-quality drugs and keep up with breakthrough changes in the market, players keep in mind the importance of AI and new equipment, because this allows them to be the first to release products, making them safe and competitive.”

All business program events and the exposition can be visited free of charge with a ticket to the exhibition. We look forward to seeing you at Pharmtech & Ingredients 2024 on November 20, 21 and 22!