Pharmaceutical Manufacturing Facility
is a complex of ultra-modern laboratories, with areas of A, B, C, D cleanliness classes, meeting the requirements of Good Manufacturing Practice (GMP) and the PN-EN ISO 14644 standard.
The quality management system functioning in the laboratory was based on the requirements of Good Manufacturing Practice (GMP), the Regulation of the Minister of Health on professional and sanitary requirements for tissue banks and the principles of Good Clinical Practice.
Nikon Eclipse Ti inverted fluorescence microscope
is one of the most technologically advanced microscopes on the market. Automation in the microscope enables speed, repeatability and greater efficiency of research. The microscope can be used in bright field and fluorescence techniques. It is equipped with temperature, humidity and gas composition control systems. Thanks to that, this device can provide stable, fully controlled ambient conditions, which gives the possibility of imaging cells during culture.
7500 Fast Real-Time System thermal cycler
together with a dedicated PCR chamber, it allows you to perform both quantitative and qualitative determinations in real time. The 96-well plate format and the speed of the thermal cycles ensure high throughput of determinations in a very short time. A wide range of calibrated dyes increases the possibility of reagents used in experiments and allows for multiplexing of reactions. We also have the NanoDrop 2000 UV-Vis spectrophotometer by Thermo Scientific for quick analysis of RNA, DNA and proteins in small volumes.
CytoFLEX flow cytometer from Beckman Coulter
The modern Beckman Coulter CytoFLEX flow cytometer with CytExpert software, equipped with three lasers: blue 488 nm, red 638 nm and violet 405 nm, enables the analysis of 13 color markers. The device is characterized by high sensitivity and enables quantitative and qualitative measurements of physicochemical and biological cells and particles.
BACTEC FX 80
BACTEC FX is an automated system designed to detect microbial growth in biological samples. The device utilizes special culture bottles containing a microbiological medium and a chemical sensor capable of detecting changes in carbon dioxide (CO₂) concentration. The system's operating principle is based on microbial metabolism: living microorganisms, utilizing the nutrients contained in the medium, release CO₂. Each bottle contains a fluorescent sensor that responds to increases in CO₂ concentration. In the presence of microorganisms, the sensor's fluorescence intensity increases, which is automatically monitored by the device. Analysis of the rate and magnitude of the signal increase allows for the detection of microorganisms and a positive result.
The BACTEC FX system is primarily used in:
• clinical diagnostics (e.g., detection of bacteremia and sepsis),
• sterility monitoring of medicinal products, including advanced therapy products (ATMP),
• microbiological tests conducted in accordance with the requirements of the Polish Pharmacopoeia.
Endosafe Nexgen
Endosafe Nexgen is an advanced system for determining bacterial endotoxins using the Limulus Amebocyte Lysate (LAL) method, a kinetic-chromogenic method in which endotoxins activate an enzymatic cascade leading to the formation of a colored product. The color intensity is directly proportional to the endotoxin concentration and is measured photometrically by the device.
Endosafe Nexgen is used in:
• quality control of medicinal products and medical devices in accordance with the requirements of the Polish Pharmacopoeia,
• monitoring the microbiological purity of water for injection (WFI) and raw materials.
