State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization: The NISTmAb Case Study

Autor: John E. Schiel, Darryl L. Davis, Oleg V. Borisov, Trina Formolo, Mellisa Ly, Michaella Levy, Lisa Kilpatrick, Scott Lute, Karen Phinney, Lisa Marzilli, Kurt Brorson, Michael Boyne, Darryl Davis, John Schiel, Melissa Alvarez, James A. Carroll, Paul W. Brown, Wenzhou Li, James L. Kerwin, Andrew Mahan, Sabrina A. Benchaar, Justin M. Prien, Henning Stöckmann, Simone Albrecht, Silvia M. Martin, Matthew Varatta, Marsha Furtado, Stephen Hosselet, Meiyao Wang, Pauline M. Rudd, David A. Michels, Anna Y. Ip, Thomas M. Dillon, Brittany Chavez, Ken M. Prentice, Lowell J. Brady, Karen J. Miller, Yatin Gokarn, Sanjeev Agarwal, Kelly Arthur, Alexander Bepperling, Eric S. Day, Dana Filoti, Daniel G. Greene, David Hayes, Rachel Kroe-Barrett, Thomas Laue, Jasper Lin, Brian McGarry, Vladimir Razinkov, Sanjaya Singh, Rosalynn Taing, Sathyadevi Venkataramani, William Weiss, Danlin Yang, Isidro E. Zarraga, Dorina Saro, Audrey Baker, Robert Hepler, Stacey Spencer, Rick Bruce, Steven LaBrenz, Mark Chiu, Steven E. Lang, Dean C. Ripple, Linda O. Narhi, Kesh Prakash, Weibin Che

Recognition and identification of UV-absorbing leachables in EPREX pre-filled syringes: an unexpected occurrence at a formulation-component interface

Autor: James, Pang, Tim, Blanc, John, Brown, Steven, Labrenz, Annabelle, Villalobos, Anneli, Depaolis, Srinivas, Gunturi, Steve, Grossman, Peter, Lisi, George A, Heavner

Publikováno v: PDA journal of pharmaceutical science and technology. 61(6)

During the period of 1998 to 2002, there was an increase in the incidence of antibody-positive pure red cell aplasia (PRCA) in patients receiving subcutaneous administration of EPREX (epoetinum alfa). As part of the investigation of this event, the a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::8628c926644e7a4ccccc45723c99a5f9
https://pubmed.ncbi.nlm.nih.gov/18410043