Zobrazeno 1 - 10
of 14
pro vyhledávání: '"Roberto A DePaz"'
Autor:
Jared S. Bee, Yu Zhang, Sheyla Finkner, Kristin O'Berry, Akanksha Kaushal, Megan Kuhn Phillippi, Roberto A. DePaz, Keith Webber, Tristan Marshall
Publikováno v:
Journal of Pharmaceutical Sciences. 111:1868-1878
Autor:
Jared S, Bee, Yu, Zhang, Sheyla, Finkner, Kristin, O'Berry, Akanksha, Kaushal, Megan Kuhn, Phillippi, Roberto A, DePaz, Keith, Webber, Tristan, Marshall
Publikováno v:
Journal of pharmaceutical sciences. 111(7)
Gene therapies delivered using adeno-associated virus (AAV) vectors are showing promise for many diseases. Frozen AAV drug products are exposed to freeze-thaw (F/T) cycles during manufacturing, storage, and distribution. In this work we studied the m
Publikováno v:
International journal of pharmaceutics. 606
Adeno-associated viruses (AAV) are among the most actively investigated vectors for gene therapy. Supply of early clinical studies with frozen drug product (DP) can accelerate timelines and minimize degradation risks. In the long-term, logistical cha
Autor:
Yu Zoe Zhang, Jared S. Bee, Megan Kuhn Phillippi, Kristin B. O'berry, Roberto A DePaz, Akanksha Kaushal, Tristan Marshall
Publikováno v:
Journal of pharmaceutical sciences. 110(9)
Adeno-associated virus (AAV) vectors for gene therapy have potential to provide a durable treatment response for a number of diseases with unmet need. DNA is released from AAV capsids at high temperatures. Less is known about DNA release that may occ
Publikováno v:
Analytical Chemistry. 91:4107-4115
Water proton transverse relaxation rate R2(1H2O) measurements by NMR stand out as a powerful noninvasive tool to detect protein aggregates, including subvisible particles in biopharmaceutical formulations. To understand the applicability of water pro
Publikováno v:
Analytical Chemistry. 89:5494-5502
Formulation stability is a critical attribute of any protein-based biopharmaceutical drug due to a protein’s inherent tendency to aggregate. Advanced analytical techniques currently used for characterization of protein aggregates are prone to a num
Autor:
Tzvetelina Chevolleau, Roberto A DePaz, Mariana N. Dimitrova, Roja Narwal, Sébastien Jouffray
Publikováno v:
Journal of Pharmaceutical Sciences. 103:1384-1393
Prefilled syringes (PFSs) offer improvements in the delivery of drugs to patients compared with traditional vial presentations and are becoming necessities in an increasingly competitive biologics market. However, the development of a product in a PF
Publikováno v:
Journal of pharmaceutical sciences. 105(1)
This study explored the ability to conduct primary drying during lyophilization at product temperatures above the glass transition temperature of the maximally freeze-concentrated solution (Tg′) in amorphous formulations for four proteins from thre
Autor:
Douglas A. Dale, John F. Carpenter, Christopher C. Barnett, Theodore W. Randolph, Roberto A. DePaz, Alfred L. Gaertner
Publikováno v:
Enzyme and Microbial Technology. 31:765-774
Proteins and enzymes for commercial use are often dried in order to extend their shelf lives. This study examined the effects of disaccharides (sucrose and trehalose), polymers (dextran and maltodextrin) and disaccharide–polymer mixtures on the sta
Publikováno v:
Translational Materials Research. 4:025002
It is shown that water proton NMR can detect uncontrolled clustering of inert nanoparticles (NPs) formulated as aqueous suspensions. The clustering of NPs causes the compartmentalization of water molecules, leading to accelerated proton spin de-coher