Search results for " meeting"
Article
From Darwin to Recombinant Fc Multimers
The conference attendees of the 10th Plasma Product Biotechnology meeting on Malta provided a wide spectrum of topics from May 15-18.
The Plasma Product Biotechnology (PPB) meeting series is a joi…
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High-Throughput Process Development in an Historical Environment
After previous meetings in Krakow, Poland and Avignon, France, the 3rd international conference devoted to HTPD was most recently held October 6-9 in Siena, Italy, yet another beautiful city on the UN…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
… and variation due to unknown model parameters, to determine a design space with high reliability of meeting the CQAs.
Design space models often become a series of complex, multifactor equa…
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Report from the 12th Plasma Product Biotechnology Forum
The meeting attracted close to one hundred delegates from 19 countries with representatives from 33 businesses and institutions, including all the major global plasma fractionation companies.
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The Development and Application of a Monoclonal Antibody Purification Platform
Although the current process bucks the trend of reducing the number of unit operations, it increases the chance of meeting the purification needs of a greater number of projects in a shorter time fram…
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
In addition, manufacturers pursuing initial development of novel gene and cellular therapies now may gain early advice from less formal meetings with FDA experts. A new INTERACT program (Initial Targe…
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Modeling and Miniaturization: Key Topics at Successful HTPD Conference
…er the course of the four-day conference, and the discussions and exchange of infromation during the meeting was both open and intense.
The HTPD conference series started as a joint initiativ…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Bhattacharyya, “A Novel Approach to the Development of ID Release Tests for Resins and Growth Media,” presentation at the 2nd Annual Meeting on Raw Materials and Contract Services for Mammalian Cell P…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
In addition to meeting the regulatory requirements that ensure the safety and efficacy of biopharmaceuticals for clinical and commercial applications, the strategy presented here also provides an appr…
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Using Quality by Design to Develop Robust Chromatographic Methods
Based on the statistical modelling from DoE-1 and DoE-2, the entire white region in Figure 8 is predicted to be capable of meeting the ATP acceptance criteria. For operator simplicity, however, the op…