- 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 mid-2023 with full completion scheduled for Q1 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.
Our products are manufactured in accordance with the most stringent requirements of our customers and health authorities. 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. Our products can be additionally tested in compliance with the customer’s specifications.
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 mid-2023 with full completion scheduled for Q1 2024.
Cryogenic
High Potent
Capabilities
Polpharma API Business Unit takes the advantage of entering into new, highly specialized area of high potent API development and manufacturing, as an important milestone in our growth strategy.
New greenfield R&D and production facility dedicated to HP API products with OEL down to 10ng/m3 (OEB 6) is planned to be launched in H2 of 2024.
The plant capabilities shall provide GMP and FDA compliant kilo-scale production of batch size up to 1,5 kg together with separate analytical (ADL) and process development laboratories (PDL).The design of the plant assumes best in class isolator technology to be used for personnel and product safety, as well as all industry standard secondary containment solutions built into the plan 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 capacity
Equipment type:
- 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
