Zobrazeno 1 - 10
of 19
pro vyhledávání: '"Ren-Yo Forng"'
Autor:
Tammy L, Thurman, Carol J, Lahti, Jeanne M, Mateffy, Ren-Yo, Forng, Friedrich, von Wintzingerode, Lindsey M, Silva, Sven M, Deutschmann, Ned, Mozier
Publikováno v:
ALTEX.
The use of pyrogen tests to assess the risk of endotoxin in biological products has increased recently due to concerns of some regulatory authorities about products exhibiting low endotoxin recovery (LER). Manufacturers increasingly seek to reduce th
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5f9b8c07f8c7cffdfb41ef64cb9748a6
https://pubmed.ncbi.nlm.nih.gov/35796330
https://pubmed.ncbi.nlm.nih.gov/35796330
Autor:
Thurman, Tammy L., Lahti, Carol J., Mateffy, Jeanne M., Ren-Yo Forng, Wintzingerode, Friedrich von, Silva, Lindsey M., Deutschmann, Sven M., Mozier, Ned M.
Publikováno v:
Altex; 2023, Vol. 40 Issue 1, p117-124, 8p
Autor:
Elaine Speirs, Brian L. Bell, Lia Jeffrey, Ren-Yo Forng, Kate Young, Michael Knight, James Malavich, Timothy Cirbo, Mousumi Paul, James Moshi, Stephen Yang, Daniel Cavanagh, Chrissy Chu, BioPhorum, Kathleen Zagaroli, Barbara Daddis
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::82d4c562c2e60e680f9e369888120bd5
https://doi.org/10.46220/2021ds004
https://doi.org/10.46220/2021ds004
Autor:
Ren-Yo Forng, Scott Hooper, Gilberto Dalmaso, Allison Scott, James Francis, Mike Russ, Philip Villari, Mike Dingle, James Cannon
Publikováno v:
PDA journal of pharmaceutical science and technology. 75(2)
The Process and Environmental Monitoring Methods Working Group, composed of members from industry and instrument manufacturers, met with the FDA Emerging Technology Team to discuss bio-fluorescent particle counting technology, a type of rapid microbi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5aa53963a693b80bbe71da4e05673643
https://pubmed.ncbi.nlm.nih.gov/33452049
https://pubmed.ncbi.nlm.nih.gov/33452049
Autor:
Shebeer Shereefa, James E. Hauschild, Pieta C. IJzerman-Boon, Robert 'Bo' Henry, Dawood Dassu, Marja Claassen, Jane Wyatt, Philip Villari, Jean-Thierry Pycke, Lisa Yan, Jeff Horsch, Aditya Prasad, Jay S. Bolden, Jeffrey Weber, Ren-Yo Forng
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 73:121-134
This paper provides recommendations for quality oversight, manufacturing operations, and industry perspective of regulatory expectations to enable aseptic facilities to move toward real-time and continuous microbiological environmental monitoring, th
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ca7fa52183d042fb0d6d4fcae100fd23
https://doi.org/10.5731/pdajpst.2018.008722
https://doi.org/10.5731/pdajpst.2018.008722
Autor:
Jeffrey Weber, Ren-Yo Forng, Annett Milling, Aditya Prasad, Jay S. Bolden, Simon Urwyler, James E. Hauschild, Robert 'Bo' Henry, Philip Villari, Dawood Dassu, Jeff Horsch, Lucile Plourde, Shebeer Shereefa, Pieta C. IJzerman-Boon, Marja Claassen, Jan Erik Rau, Lisa Yan, Roland Portmann
Publikováno v:
PDA journal of pharmaceutical science and technology. 74(3)
Investigations into environmental monitoring (EM) excursions can be prolonged and do not always result in clear root causes or corrective and preventative actions. This article outlines how biofluorescent particle counting (BFPC) can be used in inves
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::485b6728330c3a43e0dd0c30a5c49ed0
https://pubmed.ncbi.nlm.nih.gov/31843986
https://pubmed.ncbi.nlm.nih.gov/31843986
Autor:
Ren-Yo Forng, Tim Cirbo, Derek Willison-Parry, Christopher Phillion, Brian Kiler, Aileen Mcmeel, Stephen Yang
Publikováno v:
PDA journal of pharmaceutical science and technology. 74(2)
For manufacturers of both sterile and nonsterile pharmaceuticals, there is an expectation that the manufacturing process is performed in a manner that prevents extraneous contamination so that the products are provided in a safe, integral, pure, and
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fbd40fba6e8f16ea657b118af3baf4dd
https://pubmed.ncbi.nlm.nih.gov/31732692
https://pubmed.ncbi.nlm.nih.gov/31732692
Autor:
Rob Grassi, James Moshi, Ren-Yo Forng, Simin Zaidi, Petra Wawra Jordi, Marcella Goodnight, Mousumi Paul, Derek Willison-Parry, Brian L. Bell, Angel Salaman, Bill Carpenter, Marie Murphy, Una Hearty, Andreas Keller
Publikováno v:
PDA journal of pharmaceutical science and technology. 72(2)
The purpose of this paper is to provide a summary of a BPOG-led industry survey of the microbiological control aspects of affinity chromatography processing in the biopharmaceutical industry. The document provides a summary of historical microbiologi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f9d6836f9427c6f78a224a0a7258ba7e
https://pubmed.ncbi.nlm.nih.gov/29444992
https://pubmed.ncbi.nlm.nih.gov/29444992
Autor:
Chad J. Ronholdt, Ren-Yo Forng, Jack Lin, Teri A. Grieb, Simon Bogdansky, Brent G. Parks, William N. Drohan, Wilson H. Burgess
Publikováno v:
Journal of Orthopaedic Research. 24:1011-1018
Screening and processing methods currently in place have made the risk of bacterial and viral infections from allograft tissues extremely low. However, the development of a terminal sterilization method that does not adversely affect tissue function
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6025e07aff515fb8529376b397901f59
https://doi.org/10.1002/jor.20079
https://doi.org/10.1002/jor.20079
Autor:
Ren-Yo Forng, Melissa Wersocki, David M. Mann, Robert W Amareld, William N. Drohan, Maureen Drohan, Wilson H. Burgess
Publikováno v:
Biologicals. 31:261-264
Human sources of urokinase have led to the contamination of in-process lots of commercially available material with human pathogens. Effective pathogen inactivation of urokinase preparations can be achieved through the use of gamma-irradiation. Addit
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::13bc9a4886ca1343968c7cf923452394
https://doi.org/10.1016/j.biologicals.2003.07.001
https://doi.org/10.1016/j.biologicals.2003.07.001