Results 101 to 110 of about 53,055 (281)

Machine Learning‐Based PAT Tool for Real‐Time Residual Moisture Monitoring in Lyophilized Biopharmaceuticals Using NIR Spectroscopy

Biotechnology and Bioengineering, EarlyView.
ABSTRACT There is a growing demand in the pharmaceutical industry to optimize analytical methodologies, reducing time and resource consumption while ensuring rapid process development and cost‐efficient manufacturing. Indeed, Food and Drug Administration (FDA) introduced the Process Analytical Technology (PAT) as an initiative enabling manufacturers to
Samuele Fiorenza, Mariapia D'Urso, Ambra Massei, Nunzia Falco, Davide Fissore, Enza Torino   +5 more
wiley   +1 more source

Characterization of solid excipients: delving deeper by probing the surface [PDF]

Performance differences in different lots of solid excipients often cannot be detected by bulk physicochemical methods. This is because some of these (performance) differences originate at the surface of individual excipient particles, accounting for ...
Shireesh Apte
core   +1 more source

Purification of Advanced Therapeutics by Flow‐Through Pseudo‐Affinity Chromatography: Bi‐Specific mABs, Fc Fusion Proteins, and Adeno‐Associated Viruses

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Modern biopharmaceutical manufacturing requires purification platforms capable of processing structurally and functionally diverse products while addressing the challenge of removing persistent and high‐risk host cell proteins (HCPs).
Wenning Chu, Eduardo Barbieri, Arianna Minzoni, Shriarjun Shastry, Jacob P. LeBarre, Qingbo Shu, Taufika Williams, Xuanwen Li, Divya Chandra, Xuankuo Xu, Jerome Bill, David Roush, Joseph Taris, Patrick Gilbert, Andre Kiesewetter, Oliver Rammo, Michael Schulte, Christopher Major, Trina Mouchahoir, Steven Cramer, Cristiana Boi, Ruben G. Carbonell, Abraham Lenhoff, Stefano Menegatti   +23 more
wiley   +1 more source

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

Organ-specific immune-mediated reactions to polyethylene glycol and polysorbate excipients: three case reports

Frontiers in Pharmacology
Drug-related acute pancreatitis (AP), acute interstitial nephritis (AIN) and drug-induced liver injury (DILI) are rare but serious adverse drug reactions (ADRs) that can have life-threatening consequences.
Olga Rogozina, Carmen Ruiz-Fernández, Susana Martín-López, Ibtissam Akatbach-Bousaid, Miguel González-Muñoz, Elena Ramírez   +5 more
doaj   +1 more source

Eudragit®‐engineered pH‐responsive probiotic microspheres with enhanced gastrointestinal resistance and prolonged storage stability for inflammatory bowel disease therapy

BMEMat, EarlyView.
This study reports the development of AMS@Eud core‐shell microspheres, combining calcium alginate and pH‐responsive Eudragit® L100, which exhibit exceptional gastrointestinal resistance and long‐term storage stability (only 5.28%–9.09% viability loss over 35 days at 4–25°C), and effectively alleviate inflammatory bowel disease via gut microbiota ...
Ming Teng, Xiaomin Luo, Peng Zhang, Chen Yang, Yuniel Ma, Xinhua Liu   +5 more
wiley   +1 more source

Quantum biology: Harnessing nano-technology’s last frontier with modified excipients and food ingredients [PDF]

, 2016
Emerging evidence indicates that quantum phenomena may be operational in biological systems despite unfavorable temperatures and environmental noise. It is possible that protein quaternary architecture may be conducive to sustaining quantum entanglement ...
Shireesh Apte
core  

Overcoming intranasal delivery barriers with ultrastable polyzwitterionic siRNA nanocages for enhanced glioblastoma therapy

BMEMat, EarlyView.
A ROS‐responsive, zwitterionic nanocage enables stable, intranasal siRNA delivery to glioblastoma, promoting deep tumor penetration via non‐degradative pathways and trigeminal nerve transport. This platform achieves durable gene silencing and tumor suppression, offering a non‐invasive, storage‐stable strategy for treating glioma and other neurological ...
Jingwen Xie, Jingxing Si, Xiaobei Deng, Jing Tan, Ruijie Zhu, Jizhou Qi, Gaoxia Ma, Bin Wang, Yi Wang, Yunzhou Guo, Yuping Chen, Shiqun Shao, Youqing Shen   +12 more
wiley   +1 more source

DSC, TGA-FTIR and FTIR Assisted by Chemometric Factor Analysis and PXRD in Assessing the Incompatibility of the Antiviral Drug Arbidol Hydrochloride with Pharmaceutical Excipients

Molecules
Arbidol hydrochloride is an antiviral product widely used in Russia and China for the treatment of, among other diseases, influenza. In recent years, it has turned out to be highly effective against COVID-19.
Barbara Rojek, Agata Bartyzel, Wiesław Sawicki, Alina Plenis   +3 more
doaj   +1 more source

Toward the harmonization of bioequivalence guidelines in Europe: Commentary on the state of the art and future priorities under ICH M13A for immediate‐release oral forms

British Journal of Clinical Pharmacology, EarlyView.
Domenico Nocera, Giusi Forastiero, Andrea Logreco, Alessia Proietti, Antonio Galluccio, Carlotta Lunghi, Elisabetta Poluzzi, Fabrizio De Ponti   +7 more
wiley   +1 more source