Polpharma - CDMO/CMO

• New chemical routes full development
• Process optimization
• Technical transfer
• Analytical methods development, transfer, validation
• Troubleshooting
• Crystallization studies
• Particle size distribution control

Our Pilot Plant is an independent, small scale FDA approved production facility counting more than 25 reactors and vessels from 50 to 650 L for a total of 6 m3 capacity.

3 different and fully segregated clean zones for final APIs processing enable 3 parallel projects to run independently. Pilot Plant operations are designed and maintained an exactly the same standard as the production environment at the target commercial scale, which ensures a smooth process transfer at a larger scale (same quality, EHS standards, format for Batch records and SOP’s are applied as for production areas).

This facility runs 24h/day and 7 days/week and giving its capacity and flexibility is used for both scale-up studies to prove process robustness and also routine manufacturing of relatively small volume commercial API. Polpharma's efforts in cost-efficiency and innovation ensure the continued growth and sustainability of the API market, providing access to effective and affordable medications.

Drug Development Capabilities

Small molecules, with OEL value 10ng/m3 (OEB 6), payloads and linkers (for ADC) ; OfferOur Pilot Plant is an independent, small scale FDA approved production facility counting more than 25 reactors and vessels from 50 to 650 L for a total of 6 m3 capacity.

3 different and fully segregated clean zones for final APIs processing enable 3 parallel projects to run independently. Pilot Plant operations are designed and maintained an exactly the same standard as the production environment at the target commercial scale, which ensures a smooth process transfer at a larger scale (same quality, EHS standards, format for Batch records and SOP’s are applied as for production areas).

This facility runs 24h/day and 7 days/week and giving its capacity and flexibility is used for both scale-up studies to prove process robustness and also routine manufacturing of relatively small volume commercial API. Polpharma's efforts in cost-efficiency and innovation ensure the continued growth and sustainability of the API market, providing access to effective and affordable medications.

Drug Development Capabilities

Small molecules, with OEL value 10ng/m3 (OEB 6), payloads and linkers (for ADC) ; Offer service: process development, analytical development, QC analysis, non GMP & GMP production, from Kilo-lab scale up to commercial.

Production Capabilities 

Reactor volume from 150 L to 6 000L in 6 interconnected buildings, operating from -50°C to +200°C pressure up to 10 bar, and highly

automated units for reaction parameters monitoring and control. Pilot Plant is an independent, small-scale FDA-approved production facility with more than 25 reactors and vessels from 50 to 650 L for a total of 6 m3 capacity. KiloLab Laboratory, under GMP conditions, OEL>200 ng/m3. 2)

Reactors:

• Glass reactor system with a volume of 30 Liters, operating in the temperature range -400C – 2000C;
• CRYO glass reactor system with a volume of 25 Liters, operating in the temperature range -800C – 2000C;
• Enameled reactor system with a volume of 63 Liters, operating in the temperature range -400C – 2000C;

:,alytical development, QC analysis, non GMP & GMP production, from Kilo-lab scale up to commercial.

Production Capities 

Reactor volume from 150 L to 6 000L in 6 interconnected buildings, operating from -50°C to +200°C pressure up to 10 bar, and highly

automated units for reaction parameters monitoring and control. Pilot Plant is an independent, small-scale FDA-approved production facility with more than 25 reactors and vessels from 50 to 650 L for a total of 6 m3 capacity. KiloLab Laboratory, under GMP conditions, OEL>200 ng/m3. 2)

Reactors:

• Glass reactor system with a volume of 30 Liters, operating in the temperature range -400C – 2000C;
• CRYO glass reactor system with a volume of 25 Liters, operating in the temperature range -800C – 2000C;
• Enameled reactor system with a volume of 63 Liters, operatin temperature range -400C – 2000C;