Results 91 to 100 of about 15,283 (290)

Inventory Replenishment and Transshipment for Distributed Autologous Cell Therapy Manufacturing Networks

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Autologous cell therapy (AuCT) manufacturing networks must balance two competing objectives: reducing cost and improving patient access to time‐sensitive therapy. This study compares three AuCT manufacturing network designs: a centralized network with a single manufacturing facility, a coordinated point‐of‐care (POC) network in which POCs can ...
Zhaowei Li, Chelsea C. White III, Kan Wang, Ben Wang   +3 more
wiley   +1 more source

High Cell Density Cultivation of HEK293 Cells Using a 2L Membrane‐Stirred Bioreactor

Biotechnology and Bioengineering, EarlyView.
ABSTRACT The use of perfusion systems for the continuous cultivation of animal cells at high cell density (HCD) for the production of recombinant proteins, viruses, and viral vectors has many advantages. Besides an enhancement of volumetric productivity and high cell viability, the product quality can be improved through a steady‐state environment ...
Lennart Jacobtorweihe, Yasemin van Heuvel, Kathrina Scheiermann, Patrick Bongartz, Yvonne Genzel, Udo Reichl   +5 more
wiley   +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

Engineering Stable Lentiviral Vector Producer Cells Improves LVV Production

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Stable lentiviral vector producer cell lines represent a promising platform for scalable and cost‐efficient vector manufacturing, yet their productivity is often limited by intrinsic host‐cell constraints. In this study, we aimed to identify cellular factors restricting LVV production in stable doxycycline‐inducible GPRTG producer cell lines ...
Jona Röscheise, Lena‐Marie Eberle, Holger Laux, Kerstin Otte   +3 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

NAFLD‐related hepatocellular carcinoma: The growing challenge

Hepatology, EarlyView., 2022
Risk and protective factors for NAFLD‐related hepatocellular carcinoma Abstract Hepatocellular carcinoma (HCC) is a common cause of cancer‐related mortality and morbidity worldwide. With the obesity pandemic, NAFLD‐related HCC is contributing to the burden of disease exponentially.
Pir Ahmad Shah, Rashmee Patil, Stephen A. Harrison   +2 more
wiley   +1 more source

Ferritin as a Nanoparticle Scaffold for Plant‐Produced Next‐Generation Subunit Vaccines

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Protein nanoparticles offer an innovative approach to next‐generation subunit vaccine development by displaying antigenic sequences on the nanoparticle surface. Compared to traditional subunit vaccines, protein nanoparticle vaccines often show improved interaction with the immune system due to their particulate size and repetitive epitope ...
Jordan T. VanderBurgt, Richard Strasser, Christopher P. Garnham, Rima Menassa   +3 more
wiley   +1 more source

Phase Ib study of anlotinib combined with TQB2450 in pretreated advanced biliary tract cancer and biomarker analysis

Hepatology, EarlyView., 2022
Phase 1b study of anlotinib combined with TQB2450 in pretreated advanced biliary tract cancer and biomarker analysis. Abstract Background and Aims We evaluated the efficacy and safety of the antiangiogenic tyrosine kinase inhibitor anlotinib plus TQB2450, a programmed death‐ligand 1 inhibitor in pretreated advanced biliary tract cancers (BTCs ...
Jun Zhou, Yongkun Sun, Wen Zhang, Jiajia Yuan, Zhi Peng, Wei Wang, Jifang Gong, Lin Yang, Yanshuo Cao, Hong Zhao, Chao Chen, Weifeng Wang, Lin Shen, Aiping Zhou   +13 more
wiley   +1 more source

Oral biopharmaceutics tools - Time for a new initiative - An introduction to the IMI project OrBiTo

, 2014
OrBiTo is a new European project within the IMI programme in the area of oral biopharmaceutics tools that includes world leading scientists from nine European universities, one regulatory agency, one non-profit research organization, four SMEs together ...
Verwei, M., Abrahamsson, B., Müllertz, A., Karlsson, C., Sydor, J., Langguth, P., Beato, S., Aarons, L., Box, K., Butler, J., Augustijns, P., Kendall, R., Muenster, U., Pepin, X., Wilson, C., Julia Frank, K., Lennernäs, H., Dressman, J., Weitschies, W., Lindahl, A., Holm, R., McAllister, M., Reppas, C., Bolger, M., Rostami-Hodjegan, A., Ojala, K., Brewster, M.   +26 more
core   +3 more sources

BIOPHARMACEUTICS AND DRUG ABSORPTION ENHANCEMENT APPROACHES

Biopharmaceutics examines how a drug’s properties, formulation variables, and physiological conditions together influence its absorption and overall bioavailability. Many new drug molecules show poor solubility, limited membrane permeability, degradation
Sakshi Patil, Pooja Babar, Ankita Pawar, Dr. Bhagyesh Janugade, Hritika Thorat   +4 more
core   +1 more source