Results 171 to 180 of about 101,810 (380)

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

Marine silicon for biomedical sustainability

BMEMat, EarlyView.
Schematic illustrating marine silicon for biomedical engineering. Abstract Despite momentous divergence from oceanic origin, human beings and marine organisms exhibit elemental homology through silicon utilization. Notably, silicon serves as a critical constituent in multiple biomedical processes.
Yahui Han, Zhibo Yang, Wei Xia, Chengtie Wu   +3 more
wiley   +1 more source

Optimizing sterile filtration of nanoemulsions through proper choice of prefilter properties

Biotechnology Progress, EarlyView.
Abstract Nanoemulsions, with droplet sizes between 20 and 200 nm, have emerged as a promising vaccine adjuvant and drug delivery system, enhancing the solubility of hydrophobic drugs for diverse applications. Sterile filtration of nanoemulsions is particularly challenging due to the similar size between the nanodroplets and the 0.2 μm nominal pore size
Shreya Kapila, Randal J. Soukup, Marissa E. Bradley, David Boyd, Andrew L. Zydney   +4 more
wiley   +1 more source

Opportunities for Improving the Drug Development Process: Results from a Survey of Industry and the FDA [PDF]

In the United States, the Food and Drug Administration (FDA) agency is responsible for regulating the safety and efficacy of biopharmaceutical drug products. Furthermore, the FDA is tasked with speeding new medical innovations to market.
Adrian H. B. Gottschalk, Ernst R. Berndt, Matthew W. Strobeck   +2 more
core  

Gundelia rosea seed: Evaluation of biopharmaceutical potential and bioactive composition

, 2019
Abdullah Dalar, Gökhan Zengin, Muzaffer Mükemre, Aydın Şükrü Bengü, Sinan İşler   +4 more
openalex   +1 more source

Artificial intelligence and machine learning‐assisted digital applications for biopharmaceutical manufacturing

Biotechnology Progress, EarlyView.
Abstract Artificial intelligence and automation are no longer just buzzwords in the biopharmaceutical industry. The manufacturing of a class of biologics, comprising monoclonal antibodies, cell therapies, and gene therapies, is far more complex than that of traditional small molecule drugs.
Shyam Panjwani, Hao Wei, John Mason
wiley   +1 more source

Selection criteria for bacterial strains and bacteriophages for the formation of industrial collection of specifically lysing bacteria: Klebsiella, Echerichia, Proteus, Pseudomonas, Staphylococcus

Биопрепараты: Профилактика, диагностика, лечение, 2018
The present article submits the results of work on the isolation and study of biological properties of bacteriophages, active against Klebsiella, Echerichia, Proteus, Pseudomonas, Staphylococcus.
E. N. Siatchikhina, P. A. Nabatnikov, S. A. Korovkin, A. V. Katlinsky, G. M. Ignatyev   +4 more
doaj  

Replication in human cells supersedes serum antigenic match for the in vivo efficacy of an A/H1N1pdm09 LAIV virus

npj Vaccines
For FluMist®/Fluenz live attenuated influenza vaccine (LAIV), efficient virus replication in human nasal epithelial cells (hNEC) is an important factor in vaccine effectiveness (VE).
Steffan Llewellyn, Katarzyna E. Schewe, Sameer Ayaz, David Burbidge, Shaun Cooper, Jonathan Crowe, Sarah Dodd, Jemma Shapanis, Katie Tudor, Kathryn Ryan, Lauren Parker, Oliver Dibben   +11 more
doaj   +1 more source

From Farming to "Pharming". Risks and Policy Challenges of Third Generation GM Crops [PDF]

Commercial and academic activities in the production of pharmaceuticals or other substances of industrial interests from genetically modified plants, i.e. molecular farming, have so far centred in the USA and Canada. Recent increases in EU activities and
Armin Spörk
core  

Effect of cell retention techniques in Komagataella phaffii lab‐scale continuous processes

Biotechnology Progress, EarlyView.
Abstract Perfusion technologies play a growing role in the implementation of continuous processes for biotherapeutics production in mammalian‐based manufacturing. However, their application to alternative production hosts is limited. Cell retention systems are of key importance for the efficiency of perfusion bioreactors.
Marina Y. Linova, Satish K. Kodiripaka, Edite Martins, Sobhana A. Sripada, Stefano Menegatti, John M. Woodley   +5 more
wiley   +1 more source