Pilot
Pilot
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 of capacity.
3 different and fully segregated clean zones for final APIs processing are enabling 3 parallel projects running independently.
Pilot Plant operations are designed and maintained in an exactly same standard as production environment at target
commercial scale which ensures a smooth process transfer at 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.
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.