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Analytical monitoring of personalized drugs containing monoclonal antibodies: An alliance of patient and personnel safety
In modern cancer therapy, both the drug and the dose administered are adapted to the patient. As a result, the required preparations are not manufactured on a large scale, but individually by pharmaceutical specialists. The pharmaceutical active substances are usually cytostatics and monoclonal antibodies with carcinogenic, mutagenic or reproduction-toxic (CMR) properties. This leads to an area of tension between patient safety and occupational safety. For the quality assurance of personalised preparations, a sampling concept was developed under the aspect of occupational safety. With this concept, five cytostatic drugs and three monoclonal antibodies in preparations were tested for identity and content. It was shown that 96% of the cytostatic preparations (n=136) and 100% of the monoclonal antibody preparations (n=10) met the legal requirements. The quality of the preparations can thus be assessed as very good. For further characterisation of the monoclonal antibodies, affinity chromatography with immobilised FcγRIIIa was performed. To enable coupling of affinity chromatography with high-resolution mass spectrometry (HRMS), 2D-HPLC was used for online desalting. It was shown that monoclonal antibodies with glycan modifications with higher galactose or lower fucose content have a higher affinity for the receptor. Furthermore, it was demonstrated that monoclonal antibodies can not only be characterised by means of affinity chromatography, 2D-HPLC and HRMS, but also distinguished from their biosimilars. As part of the work on occupational safety, a method was developed for quantifying airborne monoclonal antibodies in the trace range. Using this method, it was possible to show that there is a potential for release during patient-specific production. This is triggered by the piercing of the drug containers and the occurrence of a pressure equalisation process. The release could be quantified to 15 ng. By using pressure equalisation systems (spikes), an unintentional release can be effectively prevented. As part of ...
Analytical monitoring of personalized drugs containing monoclonal antibodies: An alliance of patient and personnel safety
In modern cancer therapy, both the drug and the dose administered are adapted to the patient. As a result, the required preparations are not manufactured on a large scale, but individually by pharmaceutical specialists. The pharmaceutical active substances are usually cytostatics and monoclonal antibodies with carcinogenic, mutagenic or reproduction-toxic (CMR) properties. This leads to an area of tension between patient safety and occupational safety. For the quality assurance of personalised preparations, a sampling concept was developed under the aspect of occupational safety. With this concept, five cytostatic drugs and three monoclonal antibodies in preparations were tested for identity and content. It was shown that 96% of the cytostatic preparations (n=136) and 100% of the monoclonal antibody preparations (n=10) met the legal requirements. The quality of the preparations can thus be assessed as very good. For further characterisation of the monoclonal antibodies, affinity chromatography with immobilised FcγRIIIa was performed. To enable coupling of affinity chromatography with high-resolution mass spectrometry (HRMS), 2D-HPLC was used for online desalting. It was shown that monoclonal antibodies with glycan modifications with higher galactose or lower fucose content have a higher affinity for the receptor. Furthermore, it was demonstrated that monoclonal antibodies can not only be characterised by means of affinity chromatography, 2D-HPLC and HRMS, but also distinguished from their biosimilars. As part of the work on occupational safety, a method was developed for quantifying airborne monoclonal antibodies in the trace range. Using this method, it was possible to show that there is a potential for release during patient-specific production. This is triggered by the piercing of the drug containers and the occurrence of a pressure equalisation process. The release could be quantified to 15 ng. By using pressure equalisation systems (spikes), an unintentional release can be effectively prevented. As part of ...
Analytical monitoring of personalized drugs containing monoclonal antibodies: An alliance of patient and personnel safety
2023-05-22
Theses
Electronic Resource
English
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