Raman spectroscopy as an alternative rapid microbial bioburden test method for continuous, automated detection of contamination in biopharmaceutical drug substance manufacturing.

Aims: To investigate an in-line Raman method capable of detecting accidental microbial contamination in pharmaceutical vessels, such as bioreactors producing monoclonal antibodies via cell culture.

Methods And Results: The Raman method consists of a multivariate model built from Raman spectra collected in-line during reduced-scale bioreactor batches producing a monoclonal antibody, as well as a reduced-scale process with intentional spiking of representative compendial method microorganisms (n = 4). The orthogonal partial least squares regression discriminant analysis model (OPLS-DA) area under the curve (AUC), specificity and sensitivity were 0.

Surgical Site Infections After Pediatric Liver Transplantation-Impact of a Change in Perioperative Prophylactic Antibiotic Protocol.

Background: In spite of improved survival rates after pediatric liver transplantation, infections remain major contributors to perioperative morbidity and mortality. This study aimed to understand the impact of type and duration of perioperative antibiotic prophylaxis (PAP) on the occurrence of surgical site infections (SSIs).

Methods: In total, 125 patients who underwent liver transplantation between 2014 and 2020 were retrospectively included.

Synthesis and new DNA targeting activity of 6- and 7-tert-butylfascaplysins.

Fascaplysin is a red cytotoxic pigment with anticancer properties isolated from the marine sponge Fascaplysinopsis sp. Recently, structure-activity relationship analysis reported by our group suggested that selective cytotoxicity of fascaplysin derivatives towards tumor cells negatively correlates with their ability to intercalate into DNA. To validate this hypothesis, we synthesized 6- and 7-tert-butylfascaplysins which reveal mitigated DNA-intercalating properties.

Anticancer Activity of the Marine Triterpene Glycoside Cucumarioside A-2 in Human Prostate Cancer Cells.

Despite recent advances in the treatment of metastatic castration-resistant prostate cancer (CRPC), treatment is inevitably hampered by the development of drug resistance. Thus, new drugs are urgently needed. We investigated the efficacy, toxicity, and mechanism of action of the marine triterpene glycoside cucumarioside A-2 (CA-2) using an in vitro CRPC model.

Affinity and Inactivation of Bacterial Endotoxins for Medical Device Materials.

Endotoxins are high-molecular-weight complexes that contain lipopolysaccharide, protein, and phospholipid originating from the outer membrane of gram-negative bacteria. As gram-negative bacteria are naturally present in a variety of sources, endotoxins are commonly identified as contaminants in manufacturing environments. In industrial applications, endotoxin often is considered difficult to inactivate and to have a strong affinity with surfaces resulting from its hydrophobic chemical structure.