“Quality Evaluation of Manipulated and Industrialized Simv

“Quality Evaluation of Manipulated and Industrialized Simvastatin Formulations. Chronic drug treatments with simvastatin may be expensive to patients, favoring the use of manipulated pharmaceutical forms as an alternative, thus, quality must be ensured. Thus,

the study addressed the quality of the reference (R), generics (G1 and G2) and similars (S1 and S2) industrialized tablets, and four pharmacy Savolitinib manipulated capsules (M1-4) of simvastatin by evaluating the average weight, dissolution profile, content of active substance and uniformity of dosage unity. All parameters tested were in accordance with the Pharmacopeias for all dosage forms, except for the uniformity of dosage unity of M4, which presented less than 75% of the expected simvastatin content with relative standard deviation of 10.30 % for three samples. Furthermore, the amount of released sinvastatin was 63.74% within 30 minutes, which is below the recommendation of the American Pharmacopeia. Thus, it was shown the importance to ensure the quality of commercially available medicines avoiding therapeutic inefficacy.”
“Here, we describe a fast, easy-to-use, and sensitive selleck method to profile in-depth structural micro-heterogeneity, including intricate N-glycosylation profiles, of monoclonal antibodies at the native intact protein level by means of mass spectrometry using a recently introduced

modified Orbitrap Exactive Plus mass spectrometer. We demonstrate the versatility Peptide 17 of our method

to probe structural micro-heterogeneity by describing the analysis of three types of molecules: (1) a non-covalently bound IgG4 hinge deleted full-antibody in equilibrium with its half-antibody, (2) IgG4 mutants exhibiting highly complex glycosylation profiles, and (3) antibody-drug conjugates. Using the modified instrument, we obtain baseline separation and accurate mass determination of all different proteoforms that may be induced, for example, by glycosylation, drug loading and partial peptide backbone-truncation. We show that our method can handle highly complex glycosylation profiles, identifying more than 20 different glycoforms per monoclonal antibody preparation and more than 30 proteoforms on a single highly purified antibody. In analyzing antibody-drug conjugates, our method also easily identifies and quantifies more than 15 structurally different proteoforms that may result from the collective differences in drug loading and glycosylation. The method presented here will aid in the comprehensive analytical and functional characterization of protein micro-heterogeneity, which is crucial for successful development and manufacturing of therapeutic antibodies”
“P75 nerve growth factor receptor (p75 NGF-R) is a low-affinity receptor expressed on the surface of neural crest-derived cells and in a variety of neural tumors. Strong p75 NGF-R expression has been found in spindle cell melanoma (SCM).

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