Zobrazeno 1 - 6
of 6
pro vyhledávání: '"Christopher James Sloey"'
Autor:
Camille Gleason, Yasser Nashed-Samuel, Joseph Phillips, Michael Akers, Christopher James Sloey
Publikováno v:
PDA journal of pharmaceutical science and technology. 73(3)
The European Pharmacopeia (Ph. Eur.) hydrolytic resistance method for glass vials is routinely used to screen pharmaceutical glass vial supply. Due to reliance on this method to reduce the risk of glass vial delamination in pharmaceutical drug produc
Publikováno v:
Journal of Pharmaceutical Sciences. 101:1378-1384
Glass particles generated by glass dissolution and delamination of the glass container for pharmaceutical products have become a major issue in the pharmaceutical industry. The observation of glass particles in certain injectable drugs, including sev
Autor:
Pavel V. Bondarenko, Sejal Gandhi, Sampathkumar Krishnan, Gang Xiao, Da Ren, Christopher James Sloey, Margaret Speed Ricci
Publikováno v:
Pharmaceutical Research. 29:209-224
An IgG1 therapeutic monoclonal antibody showed an increase in acidic or pre-peak by cation exchange chromatography (CEX) at elevated temperatures, though stable at 2–8°C long-term storage in a liquid formulation. Characterization effort was undert
Autor:
Sekhar Kanapuram, Hyojin Kim, Pavel V. Bondarenko, Louise Chen, Zhongqi Zhang, Da Ren, Christopher James Sloey
Publikováno v:
Journal of pharmaceutical sciences. 104(2)
Ethylene oxide (EtO) is widely used in sterilization of drug product primary containers and medical devices. The impact of residual EtO on protein therapeutics is of significant interest in the biopharmaceutical industry. The potential for EtO to mod
Publikováno v:
PDA journal of pharmaceutical science and technology. 67(1)
An accelerated lamellae formation (ALF) methodology has been developed to determine the delamination propensity and susceptibility of pharmaceutical glass vials. The ALF process consists of a vial wash and depyrogenation mimic procedure followed by s
Autor:
Tiansheng Li, Robert A. Briddell, Olaf B Kinstler, Michael J. Treuheit, Rahul S. Rajan, David N. Brems, Heather Yeghnazar, Alexis Lueras, Yu Zhang, Hiromi Arai, Christopher James Sloey, Mohini Aras, Weston Sutherland
Publikováno v:
Protein science : a publication of the Protein Society. 15(5)
Polyethylene glycol (PEG) conjugation to proteins has emerged as an important technology to produce drug molecules with sustained duration in the body. However, the implications of PEG conjugation to protein aggregation have not been well understood.