Search results for "host" in Articles / App Notes
Article
Preclinical Evaluation of Product Related Impurities and Variants
Further, enzyme linked immunosorbent assay (ELISA) and PicoGreen assays were performed to measure levels of host cell proteins (HCPs) and host cell DNA (HCD), respectively.
Biological characte…
Article
Development of Purification for Challenging Fc-Fusion Proteins
As tested on three Fc-fusion proteins, this process demonstrates high process yield, improved clearance of HMWs and LMWs, and efficient reduction of host cell proteins (HCP) and DNA as well as robust …
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
CHO cells are the predominant production hosts for recombinant protein production due to their adaptability to various culture conditions and plasticity with reference to genetic alterations (2–5). In…
Article
From Darwin to Recombinant Fc Multimers
Always organized on an island, this year’s event was returned to Malta, which previously hosted the meeting in 2001. Appropriately, in his opening statement, conference chairperson Joe Bertolini, R&D …
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Ensuring the Biological Integrity of Raw Materials
They rely on the host for reproduction, and sometimes incorporate their genetic material into the host cell’s genome. Viral contamination is generally the greatest contamination risk because of the ab…
Article
Process Chromatography Selection for Downstream Processing Applications
This technology can provide good host cell protein removal within a relatively broad operating window of pH and conductivity, since the binding of impurities is primarily due to van der Waals interact…
Article
A Bright Future for the Plasma Fractionation Industry
Since then, several different islands have hosted successful PPB meetings.
The 9th PPB meeting in May 2015 was no exception –140 participants from 25 different countries and representing 50 diff…
Article
Modular Manufacturing Platforms for Biologics
The pod hosts the air handlers, fire suppression system, and controls—which are all in the mechanical space—and the mechanical space is accessible from the gray space of the host facility. “The cleanr…
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Application of Quality by Design to Viral Safety
The amount of viral clearance required will depend on a host of factors, including the nature of the raw materials and the intended patient population. In the broadest sense, this comes down to a mini…
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Regulatory Challenges in the QbD Paradigm
The products can be produced from the same host or from different hosts but must be from well characterized cell lines (e.g., ICH Q5A) and not highly toxic or potent. The second case is the site trans…