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 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.

About us Polpharma Group Polpharma API API Manufacturing sites
 

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.

CDMO Competencies & Services Quality Environmental protection Customer experience
 

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.

Generics Core competencies Products
 

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.

Technologies Cryogenic High Potent Capabilities
 

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.

Our products

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 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.