Search results for "EX"

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
Acetylation of histone proteins is an important mechanism for regulating gene expression. ACN Acetonitrile; the most frequently used solvent in HPLC, commonly used as an eluent.  acidic var…

Article Addressing the challenges in downstream processing today and tomorrow
In addition to high cell density mammalian expression, expanded utilization of other expression systems such as microbial and yeast will support these newer biotherapeutics (BioTx). The diversity of B…

Article Single-Domain Antibodies for Brain Targeting
IgG, the main serum antibody, the intact form of which is almost exclusively used in therapeutic antibodies, is a Y-shaped, multidomain protein with antigen-binding sites located on the two Fab (antig…

Article Continuous Manufacturing: A Changing Processing Paradigm
Presenters of a BioPharm International webinar, “The Future of Continuous Downstream Bioprocessing,” cite continuous biomanufacturing initiatives at an Amgen Singapore plant as an example of how manuf…

Article Tools for Enabling Process Analytical Technology Applications in Biotechnology
These products have to meet high expectations with respect to product quality, as documented in the pharmacopoeias and other regulatory documents. This is important to ensure the safety and efficacy o…

Article Modular Manufacturing Platforms for Biologics
…nd where all of the cleanroom components live (inside the actual unit that is shipped or inside the existing facility infrastructure). There are modular room enclosure systems (such as from Daldrop, …

Article Challenging the cleanroom paradigm for biopharmaceutical manufacturing of bulk drug substances
DEFINITIONS Closed system: A process system with equipment designed and operated such that the product is not exposed to the room environment. Materials may be introduced to a closed system, but t…

Article Quality by design for biotechnology products—part 1
Applying those concepts to the manufacture of biotech products, however, involves some nuances and complexities. Therefore, this paper offers guidance and interpretation for implementing QbD for bioph…

Article Building a Business Case for Biopharmaceutical QbD Implementation (Peer Reviewed)
Instead, they have examined benefits across a portfolio for a company or aggregated across the pharmaceutical industry as a whole (1). In contrast, this effort focuses on a per product basis of busine…

Article A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Given this inherent genetic flux, recombinant genes (or transgenes, also referred to as the expression construct) expressed in CHO cells—used for therapeutic bioproduct development—can be subject to g…

Next Page