Plant for the production
of blood products
Compliance with standards:
GMP, GEP, GxP, ISO, national regulatory requirements of the EAEU Project cost: Estimated cost of construction and equipment: ~ 5700 million rubles (depending on technical solutions and equipment configuration). Result: Successful completion of the examination.
GMP, GEP, GxP, ISO, national regulatory requirements of the EAEU Project cost: Estimated cost of construction and equipment: ~ 5700 million rubles (depending on technical solutions and equipment configuration). Result: Successful completion of the examination.
Engineering solutions:
- High-precision HVAC systems with control of microclimate parameters and differential pressure.
- Integrated water purification systems (WFI, PW) and steam (CIP, SIP).
- Automated production management systems (MES, SCADA, BMS).
Project: Development of design documentation for a blood product manufacturing plant.
Implementation period: 13 months.
Area: 6000+ sq. m.
Equipment: 240+ units of process equipment.
Production capacity: 600 tons of plasma per year = 11 products.
Clean rooms: 78% of the area, cleanliness classes B, C, D.
Implementation period: 13 months.
Area: 6000+ sq. m.
Equipment: 240+ units of process equipment.
Production capacity: 600 tons of plasma per year = 11 products.
Clean rooms: 78% of the area, cleanliness classes B, C, D.
Laboratory creation
quality control
Project cost: Estimated cost of construction and equipment: from XX to XX million $ (depending on technical solutions and equipment configuration).
Engineering systems:
- High-precision air conditioning systems that support preset air exchange rates and pressure drops.
- HEPA-air filtration, UV disinfection, gas analysis systems.
- Automated laboratory process control systems (BMS, SCADA).
- Integrated technologies:Rational placement of equipment and materials to prevent cross-contamination.
- Local laminar zones and biosafety systems.
- Disinfection of waste before disposal in autoclaves.
- Compliance with the following standards: GMP, GDP, Gsp, ISO, SP 1.3.2322-08, SP 1.3118-13, GOST R ISO 14644.
Key project decisions:
- Clean rooms and cleanliness classes:
- Class C (ISO 7): Facilities for working with mammalian cells, viruses and viral vectors.
- Class D (ISO 8): Rooms for working with bacteria, auxiliary areas.
- Controlled unclassified areas: General laboratory and research facilities.
- Infrastructure and planning solutions:Division into "clean" and "contagious" zones.
- Localized sites for working with PBA of pathogenicity group II with independent input.
- Boxed rooms, thermostatic zones, cell culture banks. A system of gateways, transfer windows, and sanitary passageways to eliminate cross-flow.
Project: Development of design documentation for a research laboratory (R&D).
Implementation period: 7 months. Area: 1000+ sq. m.
Equipment: 120+ units of modern laboratory equipment with automated control systems.
Functional purpose: Conducting research with pathogenic biological agents (PBA groups II-IV), working with mammalian and insect cells, viral vectors, validation of analytical methods.
Implementation period: 7 months. Area: 1000+ sq. m.
Equipment: 120+ units of modern laboratory equipment with automated control systems.
Functional purpose: Conducting research with pathogenic biological agents (PBA groups II-IV), working with mammalian and insect cells, viral vectors, validation of analytical methods.
Production of nutrient
media from meat extract
Key solutions:
Project cost:
Construction and equipment: 630 million rubles
- Full cycle: raw material processing → extraction → filtration → lyophilization → packaging.
- The technology has been optimized: reduction of the production cycle by 14% relative to the laboratory scale.
- A literary review was conducted GMP, GLP, Gcp, and ISO compliance.
Project cost:
Construction and equipment: 630 million rubles
Project: Development of project documentation for the production of freeze-dried meat extract.
Implementation period: 7 months.
Area: 1200 sq. m.
Equipment: 50+ units (fermenters, reactors, separators, drying units).
Clean rooms: Class D (ISO 8), C (ISO 7).
Implementation period: 7 months.
Area: 1200 sq. m.
Equipment: 50+ units (fermenters, reactors, separators, drying units).
Clean rooms: Class D (ISO 8), C (ISO 7).
Digitalization of productionand implementation of automation systems
Project:
- Digitalization of production and implementation of automation systems
- Terms of implementation: 12 months
- An object: Vaccine production complex
Metrics and performance indicators:
- OEE growth by 14-19% (increased equipment utilization).
- Reduced energy consumption by 16% due to intelligent control.
- Reduction of emergency stops by 30% due to predictive maintenance.
- Reduction of raw material losses and defects by 5% due to real-time monitoring of parameters.
- Increase production transparency by integrating SCADA/MES with ERP.
- Speeding up decision-making: real-time data collection and processing.
Key solutions:
- Development and integration of SCADA and MES for monitoring and management of production processes.
- Implementation of It for collecting data from equipment in real time.
- Data architecture development and integration with an ERP system.
- Automated control of critical parameters (temperature, pressure, speed, flow rate, load level).
- Setting up a predictive analytics system for predicting equipment failures.
- Optimize OEE (Overall equipment efficiency) and reduce unplanned downtime.
- Implementation of Automated Energy Efficiency Management (EMS).
- Scalable solutions with the ability to integrate new modules.
Vivarium for
laboratory animals
Zones:
- Control without PB: ABL1-LS (NIH, USA).
- Control with PBA: ABL2-LS (NIH, USA).
- Capacity: 700+ animals at a time.
- Clean rooms: ISO 8 and ISO 7 cleanliness classes
Project: Development of project documentation for a laboratory animal vivarium.
Implementation period: 11 months.
Area: 2770 sq. m.
Animal type: Mice, Guinea pigs, Rabbits, roosters.
Pathogenicity groups: Working with biological agents
3-4 groups.
Implementation period: 11 months.
Area: 2770 sq. m.
Animal type: Mice, Guinea pigs, Rabbits, roosters.
Pathogenicity groups: Working with biological agents
3-4 groups.
Project cost:
Construction and equipment:
1,630 million rubles
Construction and equipment:
1,630 million rubles
Key solutions:
- Full cycle: animal reception → quarantine → conducting experiments → control → disposal.
- Animal welfare system.
- Modern engineering solutions: HVAC, air and water disinfection systems.
- Control of conditions of detention: temperature, humidity, ventilation, lighting.
- Storage areas for storing feed, bedding materials, and reagents.
- Automated monitoring of the condition of animals and their environment.
Investment analysis
of pharmaceutical projects
IRR (internal rate of return) is an estimate of the profitability of a project.
The break–even point is the minimum amount of sales to make a profit.
Scenario analysis is the calculation of indicators in different market conditions.
The break–even point is the minimum amount of sales to make a profit.
Scenario analysis is the calculation of indicators in different market conditions.
Financial indicators available for calculation:
- CAPEX – costs of construction, equipment, clinical research.
- OPEX – operating expenses for production and support.
- NPV (net present value) is an estimate of the profitability of the project.
- ROI (return on investment) is an indicator of the effectiveness of investments.
Financial modeling of the project
Production load forecast
- Calculation of financial indicators (NPV, ROI, IRR).
- Determination of the break-even point.
- Scenario analysis (different development strategies).
- The investment payback forecast is for 15 years.
Production load forecast
- Calculation of optimal line loading
- Analysis of the production schedule by products.
- Choosing the optimal hardware configuration.
Product market assessment (RF, EAEU, LACB)
Investment planning and cost analysis
- Forecast of demand and sales volumes.
- Determining the market share.
- Analysis of price dynamics and pricing factors.
Investment planning and cost analysis
- Calculation of investment costs (CAPEX):
- Construction, equipment, clinical research.
- Forecast of operating costs (OPEX):
- Production costs, logistics, marketing.
- Comparison of technology options and their cost.
from concept to implementation
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