Ken Skidmore
Genentech
5 Papers
Ken Skidmore is an academic researcher from Genentech. The author has contributed to research in topics: Filtration & Covalent bond. The author has an hindex of 5, co-authored 5 publications.
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Papers
Enabling adoption of 2D-NMR for the higher order structure assessment of monoclonal antibody therapeutics
Robert G. Brinson,John P. Marino,Frank Delaglio,Luke W. Arbogast,Ryan M. Evans,Anthony J. Kearsley,Geneviève Gingras,Houman Ghasriani,Yves Aubin,Gregory K. Pierens,Xinying Jia,Mehdi Mobli,Hamish G. Grant,David W. Keizer,Kristian Schweimer,Jonas Ståhle,Göran Widmalm,Edward R. Zartler,Chad W. Lawrence,Patrick N. Reardon,John R. Cort,Ping Xu,Feng Ni,Saeko Yanaka,Koichi Kato,Stuart Parnham,Desiree Tsao,Andreas Blomgren,Torgny Rundlöf,Nils Trieloff,Peter Schmieder,Alfred Ross,Ken Skidmore,Kang Chen,David A. Keire,Darón I. Freedberg,Thea Suter-Stahel,Gerhard Wider,Gregor Ilc,Janez Plavec,Scott A. Bradley,Donna M. Baldisseri,Maurício L. Sforça,Ana Carolina de Mattos Zeri,Julie Yu Wei,Christina M. Szabo,Carlos A. Amezcua,John B. Jordan,Mats Wikström +48 more
TL;DR: The 2D-NMR method is shown to provide the measurement reliability needed to move the technique from an emerging technology to a harmonized, routine measurement that can be generally applied with great confidence to high precision assessments of the HOS of mAb-based biotherapeutics.
Clearance of extractables and leachables from single-use technologies via ultrafiltration/diafiltration operations.
TL;DR: This study demonstrated that the defined E/L spiked into a variety of protein solutions can be cleared to <1 ppm by 9 diavolumes from a maximum initial load concentration of 1,000 ppm, but in some cases a rebound effect was observed in the recovered pool to >1 ppm, which is explained in detail.
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Quantitation and characterization of process impurities and extractables in protein-containing solutions using proton NMR as a general tool.
TL;DR: The data indicate that NMR spectra can be used to quantitate a range of impurities, from small molecule components to higher molecular weight leachables, without removing protein from solution, even for high molecular weight extractables whose structures are not precisely known.
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The effects of membrane filters used in biopharmaceutical processes on the concentration and composition of polysorbate 20.
Ming Lei,Daniel P. Hewitt,Christopher Cornell,Ken Skidmore,Yung-Hsiang Kao,Jimmy Sugahara,Diane Beane,Junyan Ji +7 more
TL;DR: Polysorbate 20 (PS‐20) was altered after 30 kDa MWCO membrane filtration, possibly because the different interactions between heterogeneous PS‐20 components and the 30 k da MW CO membrane were not uniform.
16
Trisulfide modification impacts the reduction step in antibody-drug conjugation process.
Katherine Cumnock,Timothy Tully,Christopher Cornell,Matthew Hutchinson,Jeffrey Gorrell,Ken Skidmore,Yan Chen,Fredric S. Jacobson +7 more
TL;DR: It is proposed that TCEP reacts with each trisulfide Bond to form a thiophosphine and a disulfide bond, yielding no net antibody free thiols for conjugation.