Month: December 2020
Development and validation of a selective marker-based quantification of polysorbate 20 in biopharmaceutical formulations using UPLC QDa detection
Polysorbates are broadly used as non-ionic surfactant in biopharmaceutical formulations. Lately, the degradation of polysorbate moved into the main target of consideration, as a result of in a number of revealed research it was described, that stability points in polysorbate containing formulations have been noticed resulting in the formation and look of sub-visible and visual […]
Simulation of oral absorption from non-bioequivalent dosage forms of the salt of raltegravir, a poorly soluble acidic drug, using a physiologically based biopharmaceutical modeling (PBBM) approach
Non-bioequivalent plasma focus profiles amongst totally different dosage types of the salt of raltegravir, a poorly soluble acidic drug, had been investigated utilizing biorelevant in vitro testing mixed with the business in silico software program, Simcyp®. A suspension and a pill dosage types of raltegravir potassium had been chosen because the take a look at […]
Solid Lipid Nanoparticles for Drug Delivery: Pharmacological and Biopharmaceutical Aspects
Within the golden age of pharmaceutical nanocarriers, we’re witnessing a maturation stage of the unique ideas and concepts. There is no such thing as a doubt that nanoformulations are extraordinarily beneficial instruments for drug supply purposes; the present problem is the way to optimize them to make sure that they’re protected, efficient and scalable, in […]
Safety and Biopharmaceutical Challenges of Excipients in Off-Label Pediatric Formulations
Background: One of many main challenges in pediatric remedy is the dearth of appropriate drug preparations particularly designed and marketed for kids. A lot of the FDA accredited drug formulations for adults haven’t been accredited to be used in pediatric sufferers. Scarcity of appropriate pediatric dosage info usually leads well being professionals to make use of […]
Glycine additive facilitates site-specific glycosylation profiling of biopharmaceuticals by ion-pairing hydrophilic interaction chromatography mass spectrometry
Many biotherapeutics corresponding to monoclonal antibodies (mAb) and Fc-domain fusion proteins include heterogeneous glycan contents at one or a number of glycosylation website(s). Website-specific glycan profile characterization is important for monitoring the standard of those molecules throughout totally different phases of drug improvement. Hydrophilic interplay chromatography (HILIC) as an orthogonal separation methodology to reversed-phase liquid […]
The navigating and de-risking role of 89 Zr-immuno-PET in the development of biopharmaceuticals
The identification of molecular drivers of illness and the compelling rise of biotherapeutics similar to peptides, monoclonal antibodies, antibody fragments and non-traditional binding scaffolds, activatable antibodies, bispecific antibodies, immunocytokines, antibody drug conjugates, enzymes, polynucleotides, therapeutic cells in addition to different drug carriers like nanoparticles have impacted medical care but in addition got here with challenges. […]