Search results for "Q"

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
  A B C D E F G H I J K L M N O P Q R S T U V W X Y Z  BIOTERMINOLOGY AND DEFINITIONS Acronyms The following acronyms that appear in brackets throughout the guide represent the sources …

Article Addressing the challenges in downstream processing today and tomorrow
The diversity of BioTx and expression systems will pose unique challenges for downstream development. Novel tools, approaches, and/or platforms will be required to enable rapid development. Furthermor…

Article Single-Domain Antibodies for Brain Targeting
There is, however, a range of applications for which the Fc-mediated effects are neither required nor are desirable. Inappropriate activation of the Fc receptor-expressing cells by antibodies can lead…

Article Continuous Manufacturing: A Changing Processing Paradigm
GlaxoSmithKline, Johnson & Johnson, Genzyme, Bristol-Myers Squibb, AstraZeneca, Samsung BioLogics, and Novartis AG are among the pharmaceutical companies and contract organizations building or expandi…

Article Tools for Enabling Process Analytical Technology Applications in Biotechnology
…onducted in an integrated manner (see Table I), the emphasis in this article is on analytical techniques that enable the monitoring of critical performance attributes of raw and in-process materials …

Article Modular Manufacturing Platforms for Biologics
They can also include configurable skids; process modules/skids based on single-use equipment; or unit operations within modules, such as suites made exclusively for aseptic filling of prefilled syrin…

Article Challenging the cleanroom paradigm for biopharmaceutical manufacturing of bulk drug substances
These controls were developed through interpretation of regulatory requirements for both nonsterile and sterile biologics manufacturing decades ago and have been replicated based on successful regulat…

Article Quality by design for biotechnology products—part 1
…lejohn, Jim Precup, John Towns ABSTRACT The International Conference on Harmonization (ICH) Q8(R2), Q9, and Q10 guidelines provide the foundation for implementing Quality by Design (QbD). App…

Article Building a Business Case for Biopharmaceutical QbD Implementation (Peer Reviewed)
… ABSTRACT The aim of this paper is to describe a methodology for developing a per product qualitative and semi-quantitative business case for application of quality-by-design (QbD) for a bi…

Article A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
During this period of explosion in the application of CHO expression systems, considerable efforts have been made to improve recombinant protein production to meet the demands of high quantity and con…

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