Results 51 to 60 of about 23,818,397 (163)

Host Cell Protein Challenges in Antibody Processing: Insights Into Persistence and Mitigation Strategies

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Persistence of HCPs remains a major purification challenge in biopharmaceutical manufacturing with direct consequences for product quality, patient safety, and regulatory compliance. Over the last two decades, deeper insights into the mechanisms driving HCP persistence have clarified why certain proteins evade removal during purification ...
Younghoon Oh, Andrew Cooke, Harshal Soni, Susan Liu, Mamadou Bah, Brianna Bellis, Laura Smith, Michael Capaldi, Nicholas Levy, Erik Wilhelm, Kristopher Barnthouse   +10 more
wiley   +1 more source

Engineered immunostimulatory H2O2‐producing microreactors driven by yeast as localized living cancer therapeutics

BMEMat, EarlyView.
Engineered yeast microreactors that produce H2O2 within tumors enable selective cancer cell killing while releasing immunostimulatory components, effectively suppressing local tumor growth and activating systemic antitumor immunity, with further efficacy enhanced by anti‐PD‐1 therapy and transarterial embolization.
Wenqian He, Chunjie Wang, Minming Chen, Weihao Yang, Bin Yu, Yuhang Hu, Hengze Ding, Yifan Yan, Zhijuan Yang, Liangzhu Feng   +9 more
wiley   +1 more source

From Prediction to Decision Making: PBPK and QSP as Regulatory‐Grade NAMs

Clinical Pharmacology &Therapeutics, EarlyView.
New approach methodologies (NAMs) encompass a diverse and rapidly evolving set of experimental and computational tools designed to generate human‐relevant mechanistic data for use in drug development and regulatory decision making. Experimental NAMs provide insights into drug disposition, pharmacological activity, and disease biology that are difficult
Karen Rowland Yeo, Piet H. van der Graaf
wiley   +1 more source

Progress report on new epilepsy treatments: A summary of the Eighteenth Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XVIII). II. Treatments in more advanced clinical development

Epilepsia, EarlyView.
Abstract This article summarizes data for 13 investigational treatments for which at least preliminary seizure outcome data in patients with epilepsy were reported at the Eighteenth Eilat Conference on New Antiepileptic Drugs and Devices held in Madrid, Spain, on May 3–6, 2026.
Meir Bialer, Cecilie Johannessen Landmark, Matthias J. Koepp, Emilio Perucca, Piero Perucca, Torbjörn Tomson, H. Steve White, Elaine Wirrell   +7 more
wiley   +1 more source

Production of recombinant human granulocyte‐macrophage colony‐stimulating factor in thermoinducible E. coli: Tuning inclusion body architecture and protein yield via dissolved oxygen control

Journal of Chemical Technology &Biotechnology, EarlyView.
Abstract BACKGROUND Recombinant protein expression in Escherichia coli frequently results in the formation of inclusion bodies (IBs), which provide high protein accumulation but often require additional steps to recover functional protein. Although culture conditions strongly influence IB physicochemical and structural characteristics, the impact of ...
Ximena Gómez‐Gil, Norma A Valdez‐Cruz, Sara Restrepo‐Pineda, Nuria Sánchez‐Puig, Rafael Vázquez‐Duhalt, Rubén D Cadena‐Nava, Néstor O Pérez, Mauricio A Trujillo‐Roldán   +7 more
wiley   +1 more source

Towards Virtual Bioequivalence Studies for Oral Dosage Forms Containing Poorly Water-Soluble Drugs: A Physiologically Based Biopharmaceutics Modeling (PBBM) Approach

, 2022
S.135-145The objective of the present study was to develop a physiologically based biopharmaceutics (PBBM) approach to predict the bioequivalence of dosage forms containing poorly soluble drugs.
Dressman, J.B., Kambayashi, A.
core   +1 more source

From nature to nanoscale: advances, challenges, and preclinical translation of nanofiber drug delivery systems containing plant‐derived active ingredients

Journal of the Science of Food and Agriculture, EarlyView.
Abstract Since the early 1960s, nanotechnology has been a critical area of science, allowing for the development of sophisticated nanomaterials. Nanofibers, one of the most widely used nanotechnological drug delivery systems, have emerged as a highly versatile platform within modern pharmaceutical sciences.
Heybet Kerem Polat, Yasin Turanlı, Nihat Kurt, Sefa Gözcü, Emre Tunçel, Hilal Bacanak, Eren Aytekin, Sedat Ünal   +7 more
wiley   +1 more source

Mechanistic mass transport analysis of dissolution of weak-base drugs considering the influence of surface pH in formulations with and without acidifying agents

Frontiers in Pharmacology
At the solid–liquid interface, the dissolution of weakly basic drugs, particularly those exhibiting poor solubility, is highly sensitive to local pH conditions.
Venkata Krishna Kowthavarapu, Nitin Bharat Charbe, Tatiana Iakovleva, Cordula Stillhart, Neil John Parrott, Stephan Schmidt, Rodrigo Cristofoletti   +6 more
doaj   +1 more source

Ion Activation Methods for Top‐Down Proteomics

Mass Spectrometry Reviews, EarlyView.
ABSTRACT Mass spectrometry (MS) has emerged as a premier method used to characterize the sequences of proteins. Top‐down proteomics aims to capture the multiple sources of structural diversity reflected in proteins, such as those that arise from alternative RNA splicing events or the addition of post‐translational modifications. Tandem MS (i.e., MS/MS)
Jada N. Walker, Jennifer S. Brodbelt
wiley   +1 more source

Model‐Informed Drug Development of a Sustained Release Formulation of Flucytosine in the Treatment of Cryptococcal Meningitis: A Case Study Using Physiologically Based Pharmacokinetic Modeling

CPT: Pharmacometrics & Systems Pharmacology
This paper presents a case study demonstrating the application of model‐informed drug development (MIDD) and early modeling integration in the development of a sustained release (SR) formulation of flucytosine for cryptococcal meningoencephalitis (CM) in
Johanna Eriksson, Erik Sjögren, Jean‐Yves Gillon, Henri Caplain, Vishal Goyal, Vijay Satam, Stephen Robinson, Isabela Ribeiro, Marylore Chenel   +8 more
doaj   +1 more source