Results 231 to 240 of about 1,223,155 (304)

Decoding RNA regulation: Challenges and opportunities for RNA‐based therapies in Europe

British Journal of Clinical Pharmacology, EarlyView.
Abstract RNA‐based medicinal products represent a promising frontier in personalised medicine, offering sequence‐specific disease targeting at various molecular levels, yet their clinical translation in the European Union (EU) may be hindered by regulatory uncertainty around definitions and evidence requirements; this study therefore aims to identify ...
Olivia C. Lewis, Christine Leopold, Joyce M. Hoek, Raymond M. Schiffelers, Marie L. De Bruin   +4 more
wiley   +1 more source

Licensed and investigational TLR4 agonists as vaccine adjuvants: structural basis, clinical progress, and future directions. [PDF]

Front Immunol
Zhou J, Liu B, Yang Q, Zhou J, Zheng J, Chen Y, Fu L, Du J, Zhang Z, Zhang J, Li C.   +10 more
europepmc   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

Vaccines mimicking conformational epitopes on α-synuclein fibrils provide immunity to Parkinson's disease. [PDF]

Brain
Ma L, Reithofer S, Pesch V, Flores-Fernandez JM, Sriraman A, Duckering C, Amidian S, Özdüzenciler P, Müller L, Wille H, Tamgüney G.   +10 more
europepmc   +1 more source

What Makes an “Ideal” Cell Line for Recombinant Adeno‐Associated Virus Production?

Biotechnology and Bioengineering, EarlyView.
Several host cell types have been used to produce rAAVs to date. Cell line‐specific traits that are beneficial in the context of rAAV manufacturing are reviewed here, with the goal of developing a consensus on the ‘ideal’ characteristics that an rAAV production host should possess (created with Biorender.com).
James Conheady, Nicholas Donohue, Alexandra Bogdanovic, Sharon Davin, Brian Glennon, Niall Barron, C. Mark Smales   +6 more
wiley   +1 more source

Enhancing the Secretion Systems: Genetic Engineering of Super Bioagents for Effective Plant Disease Control

Biotechnology and Bioengineering, EarlyView.
Genetic engineering (GE) overcomes BCA limits, enabling robust, scalable crop protection. “Super Bioagents” (SBs) use optimized SSs to enhance bioactive molecule delivery. Optimizing SSs enhance precise, sustainable effector deployment for stable disease suppression. SBs use microbiome‐informed design for scalable, next‐gen sustainable crop protection.
Michael Dare Asemoloye
wiley   +1 more source

Vaccine Responses in Early Age. [PDF]

Vaccines (Basel)
Parvathaneni S, Sakai J, Liu L, Akkoyunlu M.   +3 more
europepmc   +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

Optimizing an avian influenza vaccine using a novel Bacterial Enzymatic Combinatorial Chemistry (BECC) TLR4 adjuvant. [PDF]

mSphere
Riley DV, Baracco L, Das S, Tenaglia BM, Speed S, Dillen C, Hayes J, Del Veliz S, Nijhuis H, Le Sage V, Despres HW, Coughlan L, Sun W, Frieman MB, Ernst RK.   +14 more
europepmc   +1 more source

Extracellular Vesicles‐Based Biological Macromolecule Delivery Systems: Biogenesis, Characterization, and Emerging Clinical Applications

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Extracellular vesicles (EVs) are nanoscale membrane‐bound structures that play a pivotal role in intercellular communication by transporting bioactive molecules, including proteins, lipids, nucleic acids, and organelles, between cells. Originating from the endosomal pathway, EVs reflect the physiological and pathological status of their parent
Emine İncilay Torunoğlu, Zeynep Betül Sarı, Muhammed Emin Sarı, Erdi Can Aytar   +3 more
wiley   +1 more source