Polpharma’s strategic investment in HPAPI facility

Polpharma’s strategic investment in HPAPI facility, the first of this kind in Poland and one of the most advanced in Central Easter Europe.

We are opening a new chapter in the history of Polpharma in the field of ​​active substances, becoming a strong pillar of the European pharmaceutical industry. We are proudly joining the forefront of global API manufacturers, building new opportunities and competencies that will ensure access to new generic products, and will support our strategic direction into CDMO segment in the coming decades.

Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we have launched an investment in a specialized facility for the Research and Development and Production of highly active substances with an OEL value of 10 ng/m3 (OEB 6).  
Amount of investment overall and in specific project areas:

Complete HPAPI strategy execution and grand opening of new R&D and production facility is planned for Q1 2024, with the total investment of $35m. 
 
Implementation Timeline:
H2 2024

Facilities added or expanded. Be specific as to the type of facility and location:
Greenfield construction of R&D and Production center in Starogard Gdański, Poland

Capabilities/product areas added or expanded:

Product Class
Targeted OEL
PDL/ADL/Kilolab: HPAPI handling to OEL ≥ 10ng/m3  
Targeted process outputs and regulatory compliance
PDL – scale up to 50g/batch, non-GMP area Kilo-lab – scale of 50g to 1,5kg/batch, cGMP compliant area ADL/QC – cGMP compliant area  

Specify other operational changes:
Polpharma has invested in the cryogenic infrastructure and now we are able to conduct the processes up to (-80)°C/ (-112)°F on a laboratory and pilot scale. This enables us to deal with highly reactive compounds while improving the selectivity of the reaction on a laboratory (1 liter scale), kilo lab (25 liters scale), pilot (135 liters, 400 liters) currently and manufacturing scale (2500 liters, 6000 liters) starting H1 2024.