With the size of biopharmaceutical market exponentially increasing, there is an aligned growth in importance data-rich analyses, not only to assess drug product safety but also assist development driven by deeper understanding structure/function relationships. In monoclonal antibodies, many functions are regulated N-glycans present constant region heavy chains and their mechanisms action completely known. The function focuses analytical research efforts on robust, accurate fast methods...

Comirnaty™ and Spikevax™ were the first vaccines approved for human use based on modified non-replicating mRNA lipophilic nanoparticle (mRNA-LNP) technology, with great success in treatment of COVID-19. They have been used massively worldwide. One major inconveniences these is related to pharmaceutical stability issues. Proper transportation, storage, in-use handling before administration patients are critical steps since failures can potentially reduce potency. In this research, clinical...

When therapeutic proteins are analysed under hydrophilic interaction liquid chromatography (HILIC) conditions, there is an inherent mismatch between the sample diluent (proteins must be solubilised in aqueous media) and mobile phase, which mostly composed of aprotic solvent (acetonitrile). This difference eluent strength phase responsible for severe analyte breakthrough peak distortion. As demonstrated with different sizes (insulin 6 kDa, anakinra 17 kDa rituximab subunits 25 50 kDa), only...

Teduglutide (Revestive®) is a glucagon-like peptide-2 analogue used for the treatment of short bowel syndrome, rare life-threatening condition in which amount functional gut too to enable proper absorption nutrients and fluids. During handling prior administration patient hospital, it possible that peptide-based medicines may be exposed environmental stress conditions could affect their quality. It therefore essential carry out testing studies evaluate how such respond these stresses. For...

Abstract Aflibercept (AFL) is an Fc fusion protein used in the treatment of colorectal cancers and different ophthalmological diseases. There are two medicines which AFL active substance: Zaltrap Eylea, referred as ziv-AFL respectively. No proper accelerated degradation studies were published on either or ziv-AFL. These essential during research, development manufacturing stages. Here, we characterized submitted it to stress conditions: light, 60 °C, freeze-thaw cycles, changes pH, high...

COVID-19, a disease caused by the novel coronavirus SARS-CoV-2, has produced serious emergency for global public health, placing enormous stress on national health systems in many countries. Several studies suggest that cytokine storms (interleukins) may play an important role severe cases of COVID-19. Neutralizing key inflammatory factors release syndrome (CRS) could therefore be great value reducing mortality rate. Tocilizumab (TCZ) its intravenous (IV) form administration -RoActemra® 20...

The impact of injected sample volume on apparent efficiency has been studied for very short columns in a systematic way. For large molecules such as therapeutic proteins, it was found that relatively volumes can be onto ultra-short RPLC and IEX (i.e. L < 50 mm) without significantly affecting the quality separation. This favourable behavior is due to on-off elution mechanism fact protein samples are formulated aqueous-based media, which weakest solvent IEX. Therefore, their peak strongly...

A range of biopharmaceutical products are used to target Vascular Endothelial Growth Factor (VEGF), including Eylea® (aflibercept, AFL) and Zaltrap® (ziv-aflibercept, ziv-AFL). The first is indicated for ophthalmological diseases such as neovascular (wet) age-related macular degeneration, while the second in treatment metastatic colorectal cancer. stability AFL prefilled syringes has been widely studied; however, no research yet done on ziv-AFL polyolefin infusion bags. Therefore, purpose...

Teduglutide, the active ingredient of medicine Revestive® (5 mg), is a recombinant therapeutic peptide that mimics effects endogenous glucagon-like 2 (GLP-2). It stimulates intestinal growth, adaptation and function in patients with Short Bowel Syndrome who are dependent on parenteral nutrition. The Summary Product Characteristics recommends immediate use reconstituted solutions discarding any subsequent surplus. This study aims to carry out long-term stability reproduces hospital conditions...

Therapeutic monoclonal antibodies (mAbs) represent a very important class of the current biopharmaceutics. The great complexity their structure made necessary use different analytical approaches for assessing physico-chemical properties. In this work, weak cation exchange (WCX) high performance liquid chromatography with diode array detection ((WCX)HPLC/DAD) is used to assess charge variant profile. method here developed combined effect ionic strength and controlled pH gradient allows...

Nivolumab (Opdivo®) is a fully human immunoglobulin G4 isotype approved for the treatment of many cancers. It acts as an immune checkpoint inhibitor by blocking interaction between PD-1 (Programmed Cell Death Protein 1) – inhibitory receptor expressed on activated T cells- and its ligands, PD-L1 PD-L2. The quantification therapeutic proteins in their medicines pharmaceutical preparations remains challenging because protein content, critical quality attribute, must be rigorously calculated...

The present work reports the first method for simultaneous identification, structural characterization, and quantification of therapeutic teduglutide peptide.

<h3>Background and Importance</h3> Romiplostim (N-Plate^®) is a Fc-fusion protein in which TPO agonist peptide associated with the Fc domain of human antibody. It contains two identical subunits each consisting an immunoglobulin IgG1 linked to containing receptor binding domains. This drug indicated treatment immune thrombocytopenic purpura (ITP). As proteinaceous based-medicine, romiplostim have low stability, thus studies on effects possible in-use mishandling stress conditions...

When therapeutic proteins are analysed under hydrophilic interaction chromatography (HILIC) conditions, there is an inherent mismatch between the sample diluent (proteins must be solubilised in aqueous media) and mobile phase, which mostly composed of aprotic solvent (acetonitrile). This difference eluent strength phase responsible for severe breakthrough peak distortion. As demonstrated with different sizes (insulin 6 kDa, anakinra 17 kDa rituximab subunits 25 50 kDa), only very small...

<h3>Background and importance</h3> Adalimumab (Humira 100 mg/mL) is a monoclonal antibody (mAb) which used for the treatment of psoriasis, rheumatoid arthritis Crohn's disease in adults children. Humira injected under skin. The dose child calculated according to child's weight medicine supplied prefilled syringes that are self-administered at home. has low stability after vial open therefore it necessary study its usual conditions will be exposed. In this context, charge variant...

Marketed monoclonal antibodies (mAbs) represent a very important class of the current biopharmaceutics. The great complexity their structure made necessary use different analytical approaches for assessing physico-chemical properties. In this work, weak cation exchange (CEX) high performance liquid chromatography with diode array detection ((CEX)HPLC/DAD) is used to assess charge variant profile. method developed combined effect ionic strength and controlled pH gradient allows variants...