Zobrazeno 1 - 6
of 6
pro vyhledávání: '"Derek Willison-Parry"'
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
Autor:
Rob Lynch, David Barabani, Peter Canisius, Ned Wyman, Alan Johnson, Kathy Bellorado, Derek Willison Parry, Doug Heathcote
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 72:91-103
In multi-product biopharma facilities, the protection from product contamination due to the manufacture of multiple products simultaneously is paramount to assure product quality. To that end, the use of traditional changeover methods (elastomer chan
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 70:596-599
Technology transfer of biological products is a complex process that is important for product commercialization. To achieve a successful technology transfer, the risks that arise from changes throughout the project must be managed. Iterative risk ana
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
Autor:
Jeremy Bollinger, Alan Johnson, Derek Willison-Parry, Ned Wyman, Adeyma Arroyo, Brian Goss, Joseph Wood, Michael Parks, Niamh O'Dwyer
Publikováno v:
PDA journal of pharmaceutical science and technology. 72(1)
The primary objective of any Biopharmaceutical Product Changeover (PCO) program is to employ control strategies before, during, and after the manufacturing process, as well as from the beginning of the lifecycle approach for the equipment and validat