Search results for "analytics"
Article
Moving Biosimilars Forward in a Hesitant Market
The biosimilars landscape is growing as market factors, such as pricing pressure, advanced bioprocessing and analytical technologies, and upcoming patent expirations for innovator biologics dr…
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Good Manufacturing Practices: Challenges with Compliance
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The complexity of biologics and the use of new technologies present challenges for complying with CGMPs.
By Lauren Lavelle
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Improving Upstream Predictability
He sees advances in process control and data analytics as one of the most exciting drivers of change in upstream bioprocessing. “Where we used to be able to measure basic parameters such as dissolved …
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Mapping a Route for Cell and Gene Therapy Process Development
While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.
By Cynthia A. Challener
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…
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Automating the Biomanufacturing Process
Besides data storage, analytics, and generation of process data, especially in single use (SU) processing, sensor incorporation in the biobag design is important. This allows for direct measurements w…
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Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…
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From Darwin to Recombinant Fc Multimers
…ablished analytical technology such as Surface Plasmon Resonance also could be beneficial in plasma analytics, with improved reliability and with a high degree of simplification. Data for all subclas…
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Critical Quality Attributes Challenge Biologics Development
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics.
By Susan Haigney
Critical quality attributes (CQAs) are used in biop…
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
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