Background: Streptococcus intermedius is a member of the S. anginosus group and is part of the normal oral microbiota. It can cause pyogenic infections in various organs, primarily in the head and neck area, including brain abscesses and meningitis.
View Article and Find Full Text PDFBackground And Purpose: There is concern that subvisible aggregates in biotherapeutic drug products pose a risk to patient safety. We investigated the threshold of biotherapeutic aggregates needed to induce immunogenic responses.
Methods And Results: Highly aggregated samples were tested in cell-based assays and induced cellular responses in a manner that depended on the number of particles.
Silicone oil is a commonly used lubricant in pre-filled syringes (PFSs) and can migrate over time into solution in the form of silicone oil particles (SiOPs). The presence of these SiOPs can result in elevated subvisible particle counts in PFS drug products compared to other drug presentations such as vials or cartridges. Their presence in products presents analytical challenges as they complicate quantitation and characterization of other types of subvisible particles in solution.
View Article and Find Full Text PDFBiologic drug discovery pipelines are designed to deliver protein therapeutics that have exquisite functional potency and selectivity while also manifesting biophysical characteristics suitable for manufacturing, storage, and convenient administration to patients. The ability to use computational methods to predict biophysical properties from protein sequence, potentially in combination with high throughput assays, could decrease timelines and increase the success rates for therapeutic developability engineering by eliminating lengthy and expensive cycles of recombinant protein production and testing. To support development of high-quality predictive models for antibody developability, we designed a sequence-diverse panel of 83 effector functionless IgG1 antibodies displaying a range of biophysical properties, produced and formulated each protein under standard platform conditions, and collected a comprehensive package of analytical data, including in vitro assays and in vivo mouse pharmacokinetics.
View Article and Find Full Text PDFBackground: Different oral motor appliances have been used in connection with speech therapy to improve oral motor function and speech development, but no consensus has been reached on the effectiveness of the appliances. The objective was to systematically review the effectiveness of oral motor appliances on oral motor function and speech in children with speech sound disorders (SSDs) or oral motor dysfunctions.
Methods: A systematic search was conducted up to February 2023 in the PubMed, Scopus, and Cochrane databases.