- Reactor capacity range: 0.1 to 0.5 m3
- Operational temperature: down to -80oC
- Reactor capacity range: 2.5 to 6.3 m3
- Total reactors volume: 23.5 m3
- Operational temperature: down to -80oC
We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs), that is proceeding with a $45-million manufacturing expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from 2024 with full completion scheduled for Q3 2024.
Polpharma API CDMO (Contract Development and Manufacturing Organization) supports emerging and large pharmaceutical customers in the development and commercialization of their small-molecule APIs clinical candidates thanks to +70 years of experience in process development, scale-up, and cGMP manufacturing of small molecule APIs in volumes ranging from kilos to tens of tons.
We manufacture our products by following our customers' and health authorities' most stringent requirements. DMF documentation for all our products is prepared in accordance with the latest requirements of EDQM (CEP), ICH (EuDMF, CTD), and FDA (US DMF). Material and product testing is performed in line with the European and United States Pharmacopeias.
We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs) that is proceeding with a $35-million facility expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from Q1 2024, with full completion scheduled for Q3 2024.
Cryogenic
High Potent
Capabilities
Polpharma API Business Unit takes advantage of entering into a new, highly specialized area of highly potent API development and manufacturing as an essential milestone in our growth strategy.
A new greenfield R&D and production facility dedicated to HP API products with OEL down to 10ng/m3 3(OEB 6) will be launched in Q3 of 2024.
The plant capabilities shall provide GMP and FDA-approved kilo-scale production of batch sizes up to 1,5 kg together with separate analytical (ADL) and process development laboratories (PDL).The plant's design assumes best-in-class isolator technology for personnel and product safety and all industry-standard secondary containment solutions built into the planning infrastructure.
Further future expansion is foreseen and secured by internal and external expansion capabilities, aiming to double the necessary production capacity, allowing us to grow both internally and with our CDMO business partners.
Kilo-Lab
- Products: OEL ≥ 200 ng/m3
- Reactor capacity range: 25 to 63 dm3
- Operational temperature range: (-80)oC to 200oC
Full GMP
HP API R&D
and Kilo-Lab
and Kilo-Lab
- Products: OEL: ≥10 ng/m3
- Reactor capacity range: 5 to 35 dm3
- Operational temperature range: (-20)oC to 200oC
R&D: Process Development Lab Analytical Laboratory
GMP Kilo-Lab production
Our capabilities:
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
Hazardous chemistry
The use of hazardous chemistry has an aim to reduce the number of synthesis steps as well as the number
of impurities. Our key hazardous chemistry includes:
- Grignard 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
- High pressure/high-temperature conversions
