Results 221 to 230 of about 2,653,643 (293)

Regulatory harmonization: Evolution, globalization and future directions

open access: yesBritish 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   +2 more
wiley   +1 more source

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

open access: yesBiotechnology 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   +6 more
wiley   +1 more source

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

open access: yesBiotechnology 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   +3 more
wiley   +1 more source

Feasibility Assessment of a Single‐pH Connected Polishing Train for Monoclonal Antibody Purification Using Mildly Acidic Protein A Elution and an Acidic‐Window Anion Exchange Membrane

open access: yesBiotechnology and Bioengineering, EarlyView.
ABSTRACT Monoclonal antibody downstream processing often requires multiple pH adjustments between Protein A capture and polishing steps. These adjustments increase process complexity and make direct unit‐operation connection more difficult. We evaluated a connected post‐capture polishing block operated at approximately pH 5.0 using mild‐pH Protein A ...
Takaki Aiso   +5 more
wiley   +1 more source

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