Search results for " AI"

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
anaerobic Growing in the absence of air or oxygen. Some anaerobic organisms are killed by brief exposure to oxygen, whereas it may simply retard or stop the growth of others.  analytical methods P…

Article Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology. By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…

Article Single-Domain Antibodies for Brain Targeting
Single-domain antibodies are emerging as credible alternatives due to their target specificity, high affinity, and cost-effective recombinant production. Smaller recombinant antibody fragments a…

Article Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 4 Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …

Article Tools for Enabling Process Analytical Technology Applications in Biotechnology
The success of process analytical technology (PAT), a recent initiative by FDA, depends to a large extent on efficient control of manufacturing processes to achieve predefined quality of the final p…

Article Modular Manufacturing Platforms for Biologics
A full module typically is fashioned with its own mechanical, electrical, HVAC ductwork, high-efficiency particulate air filters, and plumbing systems--and process equipment is usually already part of…

Article Challenging the cleanroom paradigm for biopharmaceutical manufacturing of bulk drug substances
The most common approach taken by the biopharmaceutical industry was to establish a secondary layer of environmental control via the application of area or room air classification. This was in additio…

Article Quality by design for biotechnology products—part 1
The QbD approach was introduced into the US Food and Drug Administration's chemistry, manufacturing, and controls (CMC) review process in 2004 with the aim of enhancing and modernizing the regulation …

Article Building a Business Case for Biopharmaceutical QbD Implementation (Peer Reviewed)
Junker is the senior director of fermentation and development operations at Merck Research Laboratories ABSTRACT The aim of this paper is to describe a methodology for developi…

Article A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells. By Luhong He, Christopher Frye Abstract …

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