The Jagiellonian Center of Innovation holds a manufacturing authorization for medicinal products in the scope of physical and chemical testing, issued by Chief Pharmaceutical Inspectorate (No. 262/0584/21), which makes it a licensed entity to conduct release testing.

We offer a range of R&D services including:

• Development of analytical methods using chromatographic, spectroscopic and classical techniques. Based on guidelines from the International Council for Harmonisation (ICH), the European Medicines Agency (EMA), and the US Food and Drug Administration (FDA).

• Validation of analytical methods (developed in the JCI Laboratory or in the Client’s Laboratory)
• Transfer of analytical methods

• Identity testing
• Content testing
• Purity testing
• Residual solvent testing
• Release profile testing
• Disintegration time testing

The Jagiellonian Center of Innovation provides a broad range of services in the field of proteomic analysis based on electrophoretic, chromatographic, and mass spectrometric techniques. The Center performs spectrometric analyses using Impact II QTOF system (Bruker), with an option of coupling to UHPLC chromatograph (Dionex). With this method, it is possible to separate complex mixtures of compounds and generate high-resolution mass spectra with mass measurement accuracy of 5 ppm (HRMS). The electrospray technique (ESI) is suitable for gentle ionization of studied molecules, while fragmentation in the collision chamber enables identification of unknown compounds.

In the area of mass spectrometry, the Laboratory offers the following analyses:

• Determination of molecular weight of proteins/peptides
• Identification of proteins and peptides based on popular databases (UniProt, NCBI)
• Identification and localization of post-translational modifications (PTMs)
• Label-free protein quantification.

The proteomic services listed above are complemented by protein characterization by electrophoretic, immunoenzymatic, and physicochemical methods. A wide array of techniques allows for the separation of proteins in complex mixtures, identification based on their molecular weight, physicochemical characterization, and analysis of a selected protein. The Laboratory also performs protein purification with the use of low pressure chromatography.

We offer a service of isolation and analysis of proteins from complex mixtures (e.g. milk, body fluids). The laboratory has the ability to purify proteins from various sources. We conduct research and development projects  in the field of isolation and biochemical analysis of proteins.

A number of methods are available in the laboratory that allow for biochemical characterization of proteins:

• Gel electrophoresis (SDS-PAGE, Native-PAGE) – Mini-PROTEAN Tetra Cell (Bio Rad)
• Western Blot – Mini Trans-Blot® Cell (Bio Rad)
• Multiangle light scattering (MALS) coupled with chromatographic system – DAWN8+ detector (WYATT) – protein molecular weight analysis in solution
• UV-VIS spectroscopy – Evolution 201 (Thermo Scientific)
• Microscale thermophoresis (MST) – Monolith NT.115 (Nanotemper) –
• Analysis of protein interactions Surface plasmon resonance (SPR) – Biacore X-100 (GE Healthcare) – analysis of protein complex binding kinetics Enzyme immunoassay
• (ELISA) – qualitative/quantitative determination of protein using immunoenzymatic assay

The laboratory has experience in conducting research and development studies in the field of biopharmaceuticals. Our team prepares the results for scientific publications. We offer substantive and practical support for start-ups in proteomic research.

The Laboratory of Chromatography and Mass Spectrometry provides services commissioned by clients in the field of physicochemical analyses in accordance with the implemented and certified standards PN-EN ISO 13485:2016 and PN-EN ISO 9001:2015.

• Analysis of extractable/leachable compounds according to ISO 10993-12 and ISO 10993-18

– carried out in conformity with the provisions of the Regulation (EU) 2017/745 of 5 April 2017 on medical devices (MDR). The analysis aims to determine the chemical profile of substances coming from the packaging or other major functional elements of the medical device tested. Based on the chemical profile and identification of chemical compounds, the level of toxicological risk of individual substances is determined in accordance with the ICH guidelines.

• Physicochemical analyses according to ISO 10993-18

– part of the biological evaluation of medical materials and devices (for human use). Such analyses include the evaluation of physical and chemical properties of various materials. The Laboratory offers services based on the techniques listed below:

– Headspace GC-MS

– GC-MS

– LC-MS

– ICP-MS

– HPLC UV/VIS, DAD, CAD

• Permeability testing

– a test consisting in checking the presence of the test sample in the receiving fluid using Franz chambers after passing through the model of a full-thickness reconstructed human epidermis. Test carried out in cooperation with the Biological Analyses Laboratory.

Get to know the quality policy of the Jagiellonian Innovation Center, the management systems and certificates we have >>>

Contact person for the services:                                                                                                            

Dominika Szot-Przewrocka, PhD
Mobile:  +48 500 538 075
E-mail: dominika.szot.przewrocka@jci.pl