Research & Manufacturing

Production

Our manufacturing plant fully complies with the highest standards of current Good Manufacturing Practices (cGMP).

Total reactor capacity is over 100 m3.

All operations involving the final products, from crystallization to packaging, are performed in a ISO Class 8.5 area.

The ratio of glass-lined to stainless steel reactor is about 1.9. Reactions are run within a temperature range of -60°C to 200°C and pressure between full vacuum and 6 Bar_g.

Our Hydrogenation plants are equipped with a full computerized reactor control system and include a single fluid heating and cooling system and cryogenic liquid nitrogen.

All our facilities are continuously upgraded in order to provide our customers with best quality products.

The finishing rooms enable us to handle dried products in line with the highest standards (ISO Class 8.5).

  • Glass, Glass-lined, Stainless steel and Hastelloy reactors
  • Centrifuges. Horizontal Peeler Centrifuge (Automated Discharge)
  • Filters: Frame Filter Presses
  • Vacuum Dryers (rotary and static)
  • Conical Mills
  • Micronizers
  • Roll compactors
  • Temperature: ranging from -20°C to 180°C
  • Pressures: from down to 5 mmHg and up to 6 Bar_g
  • Solid Handling areas

Warehouses

  • Warehouse for raw materials and finish product, including sampling and weighing rooms (Class ISO 8)
  • Special room for intermediates storage
  • Cooling containers
  • Weighing room for flammable raw materials
  • Bulk storage tanks for solvents
  • Refrigerated room for API storage
  • Freezers
  • ERP fully managed through SAP

CUSTOM MANUFACTURING

Maprimed S.A. is capable of developing a full synthetic process from lab scale to industrial plant scale, under cGMP environment. Development includes full process validation.

Maprimed S.A. is a company highly focused on customers. The unique ability to satisfy specific demands from its clients, gives a competitive advantage to us.

RESEARCH & DEVELOPMENT

Maprimed Research and Development Team has outstanding scientists, which work in state-of-the-art laboratories, equipped with the latest process and analytical instrumentation. Maprimed scientists efficiently conduct rapid process development, optimization of reaction conditions and scale-up of materials, from small-scale high potency compound to large-scale manufacturing.

Our highly skilled team of professionals have vast experience in:

  • Route evaluation and research of scalable new synthetic routes for target molecules
  • Patent analysis
  • Development of reliable methods for in-process testing and analysis of intermediates and active pharmaceutical ingredients (API)
  • Preparation of reference standards
  • Development of synthetic organic methods suitable for scaling up Optimization of reaction conditions to reduce cost and maximize throughput by classical methods or statistical design of experiments (DoE)
  • Optimization and scale-up of existing routes in jacketed glass reactors (50-8000 L capacity) to meet the customer´s supply needs.

KILOLAB PLANT

Our low scale manufacturing plant, fully complies with the highest standards of current Good Manufacturing Practices (cGMP).
The main goal of our cGMP KiloLab Plant is the synthesis of commercial lots of high-value productsup to 20 Kg/batch. High-Potency API´s are produced in classified/contained areas.

  • GLASS, GLASS-LINED, STAINLESS STEEL AND HASTELLOY REACTORS
  • CENTRIFUGES
  • FILTERS
  • VACUUM DRYERS
  • MILLS
  • MICRONIZERS
  • ISOLATORS
  • LAMINAR-FLOW CABINETS
  • TEMPERATURE: RANGING FROM -20°C TO 180°C
  • PRESSURES: FROM DOWN TO 5 MMHG AND UP TO 6 BAR_G
  • SEGREGATED HIGH-POTENCY API´S AREAS