Search results for " production"
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Host-Cell Protein Measurement and Control
During the recombinant protein production, host cells also coproduce proteins related to the normal cell functions such as cell growth, proliferation, survival, gene transcription, protein synthesis, …
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Design space models often become a series of complex, multifactor equations, which are not suitable for describing the required ranges for each CPP in a production batch record. Contained within the d…
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Moving PAT from Concept to Reality
Changes in the bioreactor conditions during protein production will impact all downstream processes. In addition, the largest number of sensor technologies available for use in biologics manufacturing…
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Ensuring Viral Safety of Viral Vaccines and Vectors
…d through a tripod strategy (Figure 1):
• Preventing entry of contamination into production processes by ensuring the quality of raw materials
• Detecting contaminants by characteriza…
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Making the Move to Continuous Chromatography
…ed, particularly when two or more unit operations are connected in a fully or semi-continuous/hybrid production process, according to Molander. Buffer consumption is also reduced.
Manufacturer…
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Use of Multivariate Data Analysis in Bioprocessing
In this 33rd article in the “Elements of Biopharmaceutical Production” series, the authors review major developments in use of MVDA in bioprocessing applications that have occurred in the past five ye…
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Securing the Single-Use Supply Chain
With this shift has come a dependence on suppliers that is related to production capabilities, a situation that did not previously exist. This reliance on suppliers translates to increased risk, and c…
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Challenges and Trends in Biopharma Facility Design
…inimizes capital investment and long-term operational costs in the facility, while still meeting the production needs the company has.
In the case of producing a blockbuster drug, a large-scale s…
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Evolution of the Monoclonal Antibody Purification Platform
Some process development related attributes with respect to production of mAbs include:
• Significant increase in titer levels over the past decade (from 0.5 mg/mL to 5-10 mg/mL)
• High pr…
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Challenges to sterility can also arise during other unit operations required for production of viral vectors. “Multiple steps are involved in upstream (e.g., seed train, infection/transfection, harves…