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Polysorbates degrading enzymes in biotherapeutics - a current status and future perspectives.
Front Bioeng Biotechnol
January 2025
Pharmaceutical Development Biologicals, TIP, Boehringer Ingelheim Pharma GmbH & Co., KG, Innovation Unit, Biberach an der Riss, Germany.
Polysorbates, in particular polysorbate (PS) 20 and 80, are the most commonly used surfactants for stabilising biotherapeutics produced by biotechnological processes. PSs are derived from ethoxylated sorbitan (a derivative of sorbitol) esterified with fatty acids of varying chain length and degree of saturation. In the past, these surfactants have been reported to have specific liabilities.
View Article and Find Full Text PDFA novel method for expressing and purifying large quantities of functional and stable human voltage-gated proton channel (hH1).
Protein Sci
February 2025
Cell Physiology and Molecular Biophysics Department, Center for Membrane Protein Research, Texas Tech University Health Sciences Center, Lubbock, Texas, USA.
Purifying membrane proteins has been the limiting step for studying their structure and function. The challenges of the process include the low expression levels in heterologous systems and the requirement for their biochemical stabilization in solution. The human voltage-gated proton channel (hH1) is a good example of that: the published protocols to express and purify hH1 produce low protein quantities at high costs, which is an issue for systematically characterizing its structure and function.
View Article and Find Full Text PDFPotential risk factors of protein aggregation in syringe handling during antibody drug dilution for intravenous administration.
J Pharm Sci
January 2025
Laboratory of Functional Molecular Chemistry, Kobe Pharmaceutical University, 4-19-1, Motoyamakita-machi, Higashinada-ku, Kobe 658-8558, Japan.
Protein aggregation, a major concern in biopharmaceutical quality control, can be accelerated by various stresses during clinical handling. This study investigated potential aggregation risk factors during dilution process with syringe handling for intravenous administration. Using γ-globulin and IgG solutions as surrogate models of antibody therapeutics, we examined the effects of high sliding speeds and piston operations of the syringe on protein aggregation during saline dilution.
View Article and Find Full Text PDFNanosuspension Innovations: Expanding Horizons in Drug Delivery Techniques.
Pharmaceutics
January 2025
Department of Pharmaceutical Sciences, College of Clinical Pharmacy, King Faisal University, Al-Ahsa 31982, Saudi Arabia.
Nanosuspensions (NS), with their submicron particle sizes and unique physicochemical properties, provide a versatile solution for enhancing the administration of medications that are not highly soluble in water or lipids. This review highlights recent advancements, future prospects, and challenges in NS-based drug delivery, particularly for oral, ocular, transdermal, pulmonary, and parenteral routes. The conversion of oral NS into powders, pellets, granules, tablets, and capsules, and their incorporation into film dosage forms to address stability concerns is thoroughly reviewed.
View Article and Find Full Text PDFPegylated NIR Fluorophore-Conjugated OBHSA Prodrug for ERα-Targeted Theranostics with Enhanced Imaging and Long-Term Retention.
Molecules
January 2025
Department of Hematology, Zhongnan Hospital of Wuhan University, Wuhan University School of Pharmaceutical Sciences, Wuhan 430071, China.
In recent years, the near-infrared (NIR) fluorescence theranostic system has garnered increasing attention for its advantages in the simultaneous diagnosis- and imaging-guided delivery of therapeutic drugs. However, challenges such as strong background fluorescence signals and rapid metabolism have hindered the achievement of sufficient contrast between tumors and surrounding tissues, limiting the system's applicability. This study aims to integrate the pegylation strategy with a tumor microenvironment-responsive approach.
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