Polpharma API is proceeding with an expansion for highly potent active pharmaceutical ingredient (HPAPI) manufacturing. Manuel Lourenco, Head of Polpharma CDMO, Polpharma API, outlined the expansion plan at the DCAT Member Company Announcement Forum held on March 18th, 2024, at DCAT Week. 

Polpharma API, an EU-based CDMO and supplier of active pharmaceutical ingredients (APIs), is proceeding with a total of $28-million investment into a specialized facility of R&D and commercial production of highly active substances with an occupational exposure limit (OEL): ≥10 ng/m³ (OEB 6). The grand opening is planned for the third quarter 2024. Polpharma API is a business unit of Polpharma Group, a leading company in the Polish pharmaceutical market and a drug manufacturer in Central and Eastern Europe.

The new HPAPI facility , which is slated to be commissioned for the third quarter of 2024, includes greenfield construction of an R&D and production center in Starogard Gdanski, Poland. The new HPAPI plant location is next to the company’s current FDA-approved API plant.

The new HPAPI facility enables handling compounds with OELs down to 10 ng/m³ and is suitable for various classes of products: 

• Compounds for antibody drug conjugates (ADCs), which combine the precision of monoclonal antibodies with the potency of cytotoxic payloads,
• HPAPIs – a specialized class of pharmaceutical compounds known with potency at low doses and are used in the treatment of cancer and other serious diseases,
• any other API with higher potencies

Construction of the HPAPI facility includes:

• ADL analytical development laboratory with GMP QC analysis capabilities, 
• PDL – process development laboratory, 
• GMP kilo-lab scale production line of max batch size up to 3 kg, with further expansion potential to double its capacity.

 Onsite equipment encompasses a various reactors, ranging from 5 to 35 dm³ in capacity and is capable of operating within a temperature spectrum from -80°C to +200°C. Additionally, the facility features processes such as isolation, drying, and milling. It is a three-story building with a total area of approximately. 3500 m². 

Other investments in a cryogenic infrastructure are under implementation. By the end of 2024, the company will implement processes requiring up to (-80)°C/ (-112)°F – from lab scale (1 liter) to pilot plant (135 and 400 liters), commercial manufacturing scale (2,500 liters, 6,000 liters). The new capabilities will be commissioned starting in the fourth quarter of 2024.