Technologies

We are a Poland-based CDMO
and manufacturer of active pharmaceutical ingredients

High Potent

As an EU-based Contract Development and Manufacturing Organization (CDMO) and supplier of active pharmaceutical ingredients, we are advancing our technology capabilities with an Occupational Exposure Limit (OEL) as low as 10 ng/m³ (OEB 6).

Our capabilities enable GMP and FDA-approved kilo-scale production, offering batch sizes of up to 1.5 kg. This facility features dedicated Analytical Development Laboratories (ADL) and Process Development Laboratories (PDL) to ensure comprehensive support for development and production phases. The design incorporates state-of-the-art isolator technology to ensure the safety of both personnel and products, along with industry-standard secondary containment solutions integrated into the infrastructure.

We have secured future capacity expansion through both internal enhancements and external partnerships, with the goal of doubling our production capacity. This strategic approach enables us to support any business opportunities.

Product Class:

OEL ≥ 10ng/m3
OEB 5/6

Infrastructure:

Process Development Laboratory (PDL)
Analytical Development Laboratory (ADL) / QC
Kilo-Lab

Targeted process outputs and regulatory compliance:

PDL-scale up to 50g/batch, non-GMP area
ADL-GMP/FDA compliant area
Kilo-Lab-scale of 50g to 1,5kg/batch, GMP/FDA compliant area

HPAPI development and manufacturing instrument

Process Development Laboratory

4x Isolators (Dispensing unit, 2x Wet units and Dry unit)
2x Reactor 1000ml
2x Reactor 250ml
4x Reactor 100ml
2x Tray Dryer

Device for High Potent API development and manufacturing

Analytical Development Laboratory + QC

5x Isolators
12x Fume Hoods
5x Ventilated Enclosures
- - HPLC with detectors: UV-Vis (PDA), RI 
- - UPLC with detectors: UV-Vis (PDA), RI, MS, FLR 
- - SFC (UPC2, Ultra-performance Supercritical Fluid Chromatography)
- - IC TGA
- - Titrators Malvern
- - IR, XRPD DSC

High Potent API manufacturing facility interior

GMP Kilo-Lab

OEL: ≥10 ng/m3
Combined Isolators (Dispensing area, Wet area and Dry area)
Reactors: 5l, 15l, 35l
Nutshe Filter
Mill
Tray Dryer

Oligonucleotides

At Polpharma API, we offer GMP-compliant oligonucleotide production with batch sizes up to 50 g, tailored to support clinical development and early commercial needs. Our facility integrates dedicated Analytical Development Laboratories (ADL) and Process Development Laboratories (PDL), ensuring robust support across all stages of development and manufacturing.

Upstream process development is powered by state-of-the-art Akta OligoSynt systems, enabling precise synthesis and scalable operations using FineLine70 and AxiTide 50 synthetic columns. For purification, we deploy advanced in-house systems across both R&D and production scales—including AktaPure 150, Akta Flux S, and the Hipersep Flowdrive Pilot with ProChrom110 column—complemented by a customized TFF ultrafiltration system for reliable isolation, concentration, and diafiltration.

We also offer lyophilization scale-up process development, optimizing the final API structure for stability and performance. All downstream operations are conducted under sterile conditions, maintaining stringent microbiological standards and ensuring low endotoxin levels in the final API.

This integrated and strategic approach positions Polpharma API to effectively support clinical trials and accelerate the development of oligonucleotide-based therapies.

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Upstream

Solid phase oligonucleotide synthesis followed by cleavage & deprotection,
filtration and concentration.

Synthesizer

ÄKTA Oligosynt
Scale <15 mmol;
FineLine 70, AxiTide 50 columns

Ammonolysis Vessel

Stainless Steel Pressure Reactor System
High pressure stainless steal ammonolysis reactor
Capacity <2 L

Downstream

Tailor-made purification process with a sterile large-scale buffer preparation system (up to 100 L),
followed by ultrafiltration, diafiltration and endotoxin removal, lyophilization, weighing and packaging.

Chromatograph

PROCHROM® HIPERSEP PILOT with Hipersep® Prochrom 110 Column
Flow rate 6–90 L/h;
1.5 L/min
100 bar

A row of machines sitting inside of a building.

UF/DF Device

Customized UF/DF system(TFF)
Tank capacity <35 L
Simultaneous production of water for injection

A machine that has a bunch of plates in it.

Lyophilizer

Epsilon 2-10D LSC plus
Lyophilizer; area <1m²

Cryogenic

Cryogenic technology is a cutting-edge field that focuses on the production and application of extremely low temperatures to create innovative solutions across various industries. At Polpharma by utilizing temperatures below -80 degrees Celsius, cryogenic processes can enhance material properties, improve efficiency, and enable the storage and transportation of products in their most stable forms.