Opinions and forecasts of experts on the production of APIs, presentation of innovative projects in the field of quality of the finalists of the GxP-PROFI 2024 competition and seminars of participants

Round table: "Raw materials for the production of APIs: how to get rid of import dependence"

One of the key events of the first day of Pharmtech & Ingredients 2024 was the round table: "Raw materials for API production: how to get rid of import dependence". Partner: REATORG. The moderator of the event was Georgy Khachiyan , editor-in-chief, "CHEMICAL EXPERT" magazine.

At the beginning of the round table, Daria Shevyakina , Deputy Director of the Department of Chemical Industry, Ministry of Industry and Trade of the Russian Federation, addressed the audience and speakers. She noted that issues of raw materials for the pharmaceutical industry have always been relevant. “I will outline the work that the Ministry is doing: today, the national project of technological leadership is at the final stage of development. From the point of view of content, we focused on complex chemical synthesis, identified specific product chains that are interconnected. As a result, you have 23 chains, among which active pharmaceutical substances are singled out as a separate one. Within this area, we are moving from the final product to the raw materials from which it is made. As a result of the analysis within the framework of preparation for the development of the chain “Active pharmaceutical substances”, a list of 361 items was formed, of which 27 components have already been included in 12 chains.”

As Daria Shevyakina added, the Ministry of Industry and Trade supported 57 projects for a total of about 9.4 billion rubles (from 2017 to 2023). However, not all supported components were in demand, and this issue always requires verification on the ground. It is important to identify critical components from more than 300 components and sort them out in order to gradually engage in import substitution. "We see a more effective dialogue and data exchange between chemistry and pharma. It is through communication that we can achieve high results," the expert added.

Statistics of the industry were presented by Raziya Solodova , head of the Analytical Center of the Federal State Budgetary Institution "GILS and NP". The average annual growth rate of the global pharmaceutical market will be 6.6%. According to the results of last year, Russia occupies 1.6% of the global pharmaceutical market. According to the speaker, intensive growth is provided by: global population aging, higher-quality diagnostics, greater investment in healthcare and greater opportunities for citizens to buy pharmaceuticals.

Next, Raziya Solodova presented the market structure by nosology. In packaging, the share of domestic drugs is 63.3%.

The average annual growth rate of the global market for active pharmaceutical ingredients (API) will be 5.8%. Over the next five years, the key factors for the development of the API market are:

// increasing prevalence of chronic diseases
// Growing demand for personalized medicine
// encouraging localization of API production to ensure supply stability.

As for statistics in the Russian Federation, as the speaker reported, API imports to Russia continued to decline in physical terms in January-May 2024. Imports from China amounted to 8.01 thousand tons, followed by Europe (29%), India (17%) and other countries (2%).

“There are currently 253 licensees registered in the Russian Federation that have the ability to produce APIs,” added Raziya Solodova.

The expert also covered the topic of creating a database for industrial synthesis of APIs using AI. Knowing the need for the necessary raw materials and supplies, molecular weight and stoichiometric coefficients, it is possible to calculate the projected need for raw materials. As was said, in 2023, the Federal State Budgetary Institution "GILS and NP" with the participation of the Research Institute of the Ministry of Finance of Russia prepared proposals for the development of API production and uninterrupted supply of finished dosage forms with them. An assessment of the need for API production in the Russian Federation was determined, an analysis of production was carried out, an analysis of imports was carried out, a register of domestic API manufacturers was formed and an assessment of the need for production capacity was made.

Irina Vendilo , CEO, Roskhimreaktiv Association, took part in the discussion of the round table topic . "On the part of the pharmaceutical industry, it is necessary to analyze the stability of raw materials and understand the aggregate demand. The most profitable projects that attract interest from chemists are those that have support from related industries. Our choice of projects is also influenced by: product cost, availability of synthesis."

Linar Fattakhov , Chairman of the Board of JSC FARUS: "We took on the implementation of one of the chains that was previously outlined by colleagues from the Ministry of Industry and Trade. During the work, it was difficult to determine who from the scientific community could take on the problem, and in the end we settled on the N.D. Zelinsky Institute of Organic Chemistry. It is the institutes that could pilot the installations and help provide consumers with the necessary raw materials. The most important thing is not to create the technology in a test tube, but to scale it up."

Alexander Pshenichny , CEO of Polisintez LLC, took part in the discussion . According to him, there have been no fundamental changes in the topic of import substitution in recent years, although large-scale work is being carried out by regulators and others. The speaker also shared his opinion that the pharmaceutical industry is stable and predictable, while being regulated and all its processes have fairly long terms, which is important for all industry participants to come to terms with.

Anton Prozumentov , Director, Medicine Division, SIBUR LLC: “We have determined for ourselves that pharma is a direction in which we are ready to develop. Changes in the market after 2022 have opened up opportunities for greater depth of localization within the framework of medicinal sovereignty.”

Among the new opportunities, the speaker highlighted:

Manufacturers of medicines:

// formation of technological and raw material independence through the formation of new chains from raw materials to the GDF
// initiative to support the Regulator (Pharma 2030, Second Wheel)

AFS manufacturers:

// expansion of product and client portfolio
// expansion of the raw material base

MTX production: - possibility to integrate into the raw materials - GLF chain.

Raw material producers:

// Formation of a raw materials portfolio for pharmaceuticals
// auxiliary substances, intermediates, solvents.

“The formation of consolidated data on volumes and specifications in intermediates and auxiliary substances allows for a better assessment of the need and economics of the project,” the expert concluded.

Petr Ryazantsev , Head of the Department for Work with AFS, R-Pharm, noted that the pharmaceutical industry is moving towards more complex chemical structures, and this lengthens the work chain. It is worth tuning in to long, smooth work designed for decades, especially this concerns the production of small-tonnage chemicals.

In conclusion, Sergey Popkov , PhD, Associate Professor, Head of the Department of Chemistry and Technology of Organic Synthesis at the Mendeleyev University of Chemical Technology of Russia, gave his commentary: “We can count on the acceleration of all processes when products of secondary chemistry appear in our country.” Answering the moderator’s question about personnel training, the expert emphasized: many students strive to go into technology development, especially when the task is to localize production.

Presentation of innovative projects in the field of quality of the finalists of the competition "GxP-PROFI 2024"

The Forum Hall hosted the presentation of projects of the International Competition "GxP-PROFI 2024". The event was moderated by Irina Spichak , Executive Director of the Eurasian Academy of Good Practices, Academician of the Russian Academy of Natural Sciences, Doctor of Pharmaceutical Sciences, Professor.

Elena Litvinova , CEO of NovaMedica Innotech LLC, a partner of the International Competition GxP-PROFI 2024 , gave a welcoming speech . Next, Igor Nikitin , Science Advisor of the Natsimbio holding, which also acted as a partner of the competition, greeted the audience and participants of the competition .

Next, the presentation of the finalist projects of "GxP-PROFI 2024" took place. The first project "Multifunctionality - a strategy for training pharmaceutical personnel" was presented by Faiza Yagudina , Quality Director of JSC "AKRIKHIN". The main goal of the project was the training and retention of personnel at the production site in the context of personnel shortages and relocation. With the help of such tools as qualification and competency matrices, individual training programs, etc., the team was able to achieve an increase in the overall interchangeability of personnel by 27.5%, a reduction in equipment downtime by 6,335 hours/year and an increase in annual productivity by 4,430 packs/person.

Ekaterina Munina , Quality Director at Valenta Pharmaceutica JSC, presented the project "Domestic Systems Guarding Quality. Not Just Using, but Creating a Better Future" . The domestic solution created by the team, EMC Valenta, includes 106 production, storage and laboratory rooms, 69 pressure sensors and 124 temperature and humidity sensors, 50 control cabinets and 4 controllers, 2 servers and more than 5 thousand tags. According to the speakers, EMC Valenta turned out to be 6 times cheaper than imported analogues.

The next company to speak was R-Pharm with the project "Labor Productivity" as part of the continuous improvement system of the company's FGC in the Pharma 4.0 concept. The report was presented by Igor Sukhomlin , project manager of JSC R-Pharm. The main goal of the project was to optimize production, technological and organizational processes using lean manufacturing tools and methods within the FGC perimeter. As a result, the production of capsules per person/day increased by 31%, the process time was reduced by 15%, and the application processing time in the SAP CS was reduced by 28%.

The project "From idea to market launch - automation of processes used in the creation of new drugs" was presented by Asmik Abrahamyan , Quality Director of JSC "Avexima". The main goal was to implement a comprehensive IT solution for the "Project Office" with a single system methodology and project management tools, covering all divisions of the group of companies. Thanks to the implementation of the solution, it was possible to reduce time costs for management by 15-20%, the project management process became simpler, and project goals were achieved on time.

The team of RUE Belmedpreparaty spoke in a special nomination for the revolutionary approach; the report was presented by Leonty Mikheev , Deputy Head of the Quality Assurance Department, Head of the Process Validation Group. The expert presented the project "Optimization and rational design of the validation of modeling aseptic processes for the production of drugs in vials of various forms of release in the conditions of one production site." The goal of the project is to adopt the correct concept for determining the frequency of scheduled revalidations and the number of validation tests with a nomenclature of over 200 items. After the implementation of the project, the experts noted a general trend towards a significant reduction in the volume of validation work. For about 30% of all manufactured products, the possibility of revalidating 2 series with a frequency of once every 5-6 years was justified.

The next project, "Interactive Report on Microbiological Monitoring Trends," was presented by Elena Izvekova , Head of the Microbiological Laboratory at Sotex PharmFirm CJSC. The introduction of interactive reports allowed the company to completely eliminate manipulations in the formation of diagrams and graphs, made it possible to prepare trend reports more quickly, see all the data in one visual field and compare them.

Zhandos Kenzhibayev , Head of Quality Assurance Department of JSC Khimfarm (Kazakhstan), presented the project "Comprehensive assessment of the risk of cross-contamination for the enterprise taking into account complicating risk factors". One of the key goals of the project was to conduct a comprehensive assessment of the risk of cross-contamination taking into account complicating risk factors and to develop a systematic approach to periodic full-scale assessment and control of cross-contamination risks. Based on the results of an in-depth analysis, the company can guarantee all its patients high safety of its drugs.

The next project was presented by Alena Kondratieva , Warehouse Manager at Pharmasyntez-Nord JSC. The goal of the project "GMP - automation of logistics/warehouse activities" was to reduce the influence of the human factor, reduce personnel and equipment operations during work, and increase the efficiency of working time. The project allowed to reduce all costs: for the purchase of consumables for printing and gluing labels - by 7 times, the time of employees working with certificate cards and labels - by 2 times (by 22 thousand hours per year). It was possible to save manual labor of warehouse employees on quarantine movement by 900 hours per year.

The final project of the International Competition "GxP-PROFI 2024" was presented by Yulia Chernyaeva , the head of the project group of the company "Geropharm". The goal of the project was to identify all the elements of the FSC that affect the release of products on time and improve them to the level of the established target indicator. Before the implementation of the project, the average value for the indicator for PROT during the observation period was 37% with a target of 80%. It was decided to change the electronic eQMS system and revise internal procedures. The implementation of the project allowed to increase the indicator for PROT to 87%.

Also on the first day of the exhibition, seminars were held by the following companies : Medtech TD LLC: "Innovative Product Print Inspector", Medtech TD LLC: "Cobetter Filters", ics-it company "Creation of a single data warehouse for manufacturers. Using data from the marking system "Honest sign (MDLP)" in business processes", GC "Labconcept": "Current capabilities for the implementation of network software at pharmaceutical enterprises for the purpose of compliance with FDA 21 CFR Part 11".

We look forward to seeing you at Pharmtech & Ingredients 2024 on November 20, 21 and 22.