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In 2022, we are opening a new chapter in the history of Polpharma in the field of ​​active substances. With the strategic investment in a HPAPI facility, Polpharma and Poland are becoming a strong pillar of the European pharmaceutical industry in the coming decades.

Grand opening of new R&D & Production Facility in Q1 2024

Completion of this investment is scheduled for the first quarter of 2024. It will include separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing Quality Control analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.

The project involves equipping laboratories with best-in-class containment technologies that protect employees against exposure to harmful substances in the form of isolators and additional solutions in the collective (secondary) protection field.

Production capacity future expansion

Our entrance into R&D and commercial scale production of highly potent substances is anticipated and secured by internal and external expansion possibilities. On one hand, we can double the production capacity by additional small-scale production line. On the other hand, we can plan the construction of a new production hall in our plant, with bigger volumes and a Quality Control laboratory adapted to the requirements of these kind of products.

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

Safety of people and the environment

The new facility’s design was developed by a recognized European constructor experienced with such complex installations. We prioritize maximum safety for personnel, products, and the environment and create comfortable working conditions while maintaining the most efficient use of the equipment and other resources.

Our HPAPI investment project took the symbolic name of Prometheus in honor of a mythological model of heroic stance and fighting for the good of people.

HPAPI Market drivers

Demand for high potency active pharmaceutical ingredients (HPAPIs) is rapidly increasing due to their ability to target diseased cells more precisely and selectively than other APIs. They are regarded as a relatively efficient treatment for cancer and various chronic diseases.

Global HPAPIs and cytotoxic drugs manufacturing market was valued at US$ 27.78 Bn in 2022 and is expected to increase to US$ 51.53 Bn by 2030, registering a CAGR of 8.0% over the forecasted period (2022 – 2030). Key market drivers such as the increasing prevalence of chronic diseases and the growing trend of contract manufacturing services are expected to fuel the growth trend.

According to the Facts & Figures provided by the American Cancer Society1, in 2022, an estimated 1.9 million new cancer cases will be diagnosed and 609,360 cancer deaths in the U.S.

Therefore, an increase in the cases of chronic diseases is expected to increase the demand for the drug, which in turn is expected to drive the growth of the HPAPIs and cytotoxic drug manufacturing market in the near future.

Moreover, the geographical expansion strategy by API manufacturers is also expected to drive market growth during the forecast period.

 

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API CDMO
API GENERICS

Source:

1. Cancer Facts & Figures 2022

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Polpharma’s strategic investment in HPAPI facility
We have launched an investment in a specialized facility
for the R&D and Production of highly active substances
with an OEL value of 10 ng/m3 (OEB 6).

The HP API investment includes separate process
laboratories (PDL), analytical laboratories (ADL)
with the possibility of performing Quality Control
analyses, and a GMP kilo-lab production line with
volume up to 1.5 kg with potential volume increase.

LEARN MORE