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of 6
pro vyhledávání: '"David Cetlin"'
Autor:
Anna Malakian, Seon Yeop Jung, Mohammad A. Afzal, Christina Carbrello, Sal Giglia, Matthew Johnson, Corinne Miller, William Rayfield, Dave Boenitz, David Cetlin, Andrew L. Zydney
Publikováno v:
Biotechnology and bioengineeringREFERENCES. 119(8)
The development of continuous/connected bioprocesses requires new approaches for viral clearance validation, both for specific unit operations and for the overall process. In this study, we have developed a transient inline spiking system that can be
Autor:
Daniel B. Gowetski, Zachary J. Schneiderman, David Cetlin, Sarah O’Connell, Nicole L. Cibelli, Gabriel F. Arias, Krishana Gulla
Publikováno v:
Biotechnology journalREFERENCES. 16(9)
High throughput process development (HTPD) using liquid handling robotics and RoboColumns is an established methodology in downstream process development to screen chromatography resins and optimize process designs to meet target product profiles. Ho
Autor:
Melanie Pallansch, Coral Fulton, Arun K. Dhar, Taka Sohka, David Cetlin, Esha Vyas, Luke Pallansch, Daniel Strauss, Aesha Shah
Publikováno v:
Biotechnology Progress. 34:1213-1220
Viruses can arise during the manufacture of biopharmaceuticals through contamination or endogenous expression of viral sequences. Regulatory agencies require "viral clearance" validation studies for each biopharmaceutical prior to approval. These stu
Autor:
Melanie Pallansch, Luke Pallansch, Robert Barlow, Joshua D. Orchard, Arun K. Dhar, David Cetlin, Jon Borman, Matt Dickson
Publikováno v:
Biotechnology Progress. 36
Viral contamination is an inherent risk during the manufacture of biopharmaceuticals. As such, biopharmaceutical companies must demonstrate the viral clearance efficacy of their downstream process steps prior to clinical trials and commercial approva
Publikováno v:
Applied Biochemistry and Biotechnology. 183:318-331
Viral clearance is a critical aspect of biopharmaceutical manufacturing process validation. To determine the viral clearance efficacy of downstream chromatography and filtration steps, live viral "spiking" studies are conducted with model mammalian v
Publikováno v:
Journal of Pharmaceutical Sciences. 103:890-899
Filtration to remove viruses is one of the single most expensive steps in the production of mAb drug products. Therefore, virus filtration steps should be fully optimized, and any decline in flow rates warrants investigation into the causes of such m