Technologies
We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs).
High Potent
As an EU-based Contract Development and Manufacturing Organization (CDMO) and supplier of active pharmaceutical ingredients, we are advancing our technology capabilities with an Occupational Exposure Limit (OEL) as low as 10 ng/m³ (OEB 6).
Our new capabilities enable GMP and FDA-approved kilo-scale production, offering batch sizes of up to 1.5 kg. This facility features dedicated Analytical Development Laboratories (ADL) and Process Development Laboratories (PDL) to ensure comprehensive support for all production phases. The design incorporates state-of-the-art isolator technology to ensure the safety of both personnel and products, along with industry-standard secondary containment solutions integrated into the infrastructure.
We have secured future capacity expansion through both internal enhancements and external partnerships, with the goal of doubling our production capacity. This strategic approach will enable us to support any future business opportunities.
Product Class:
- OEL ≥ 10ng/m3
- OEB 5/6
Infrastructure:
- Process Development Laboratory (PDL)
- Analytical Development Laboratory (ADL) / QC
- Kilo-Lab
Targeted process outputs and regulatory compliance:
- PDL-scale up to 50g/batch, non-GMP area
- ADL-GMP/FDA compliant area
- Kilo-Lab-scale of 50g to 1,5kg/batch, GMP/FDA compliant area
Process Development Laboratory
- 4x Isolators (Dispensing unit, 2x Wet units and Dry unit)
- 2x Reactor 1000ml
- 2x Reactor 250ml
- 4x Reactor 100ml
- 2x Tray Dryer
Analytical Development Laboratory + QC
- 5x Isolators
- 12x Fume Hoods
- 5x Ventilated Enclosures
- - HPLC with detectors: UV-Vis (PDA), RI
- - UPLC with detectors: UV-Vis (PDA), RI, MS, FLR
- - SFC (UPC2, Ultra-performance Supercritical Fluid Chromatography)
- - IC TGA
- - Titrators Malvern
- - IR, XRPD DSC
GMP Kilo-Lab
- OEL: ≥10 ng/m3
- Combined Isolators (Dispensing area, Wet area and Dry area)
- Reactors: 5l, 15l, 35l
- Nutshe Filter
- Mill
- Tray Dryer
Cryogenic
Cryogenic technology is a cutting-edge field that focuses on the production and application of extremely low temperatures to create innovative solutions across various industries. At Polpharma by utilizing temperatures below -80 degrees Celsius, cryogenic processes can enhance material properties, improve efficiency, and enable the storage and transportation of products in their most stable forms.
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Pilot scale
- Reactor capacity range: 0.1 to 0.5 m3
- Operational temperature: down to -80oC
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Kilo-Lab
- Glass reactor: 35 Liters
- Operational temperature: down to -80oC
- GMP conditions
Commercial scale
- Reactor capacity range: 2.5 to 6.3 m3
- Total reactors volume: 23.5 m3
- Operational temperature: down to -80oC
Capabilities
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Equipment type
- Various types of reactors
- Columns
- Crystallizers
- Centrifuges
- Dryers
- Filter-dryers
- Mills
- Micronizers
- Lyophilizer
Operating ranges
- Temp. -80°C to +200°C
- Pressure -1 to +10 bars
- pH in the full range
Operating ranges
Pilot Plant
- Temp. -80°C to +200°C
- Pressure -1 to +10 bars
- pH in the full range
Equipment type
- Gringard reactions
- Catalyzed hydrogenation
- Metallation - Lithiation
- Superbases handling – alkyllithium, hydrides
- Lewis acid catalysis – boron/aluminum compounds
- Concentrated/gaseous ammonia handling
- Bromination/Chlorination
- Bisphosphonation
- Friedel-Crafts alkylation/acylation
- Inter- and intramolecular condensations
