Search results for " control" in Articles / App Notes
Article
Challenges of Protein Aggregation During Purification
If not controlled, however, Vedantham notes that these operations may also lead to an increase in aggregates, typically due to protein unfolding while the protein is adsorbed on the stationary phase. …
Article
Design of Experiments for Analytical Method Development and Validation
• Identify the error control plan and run the study.
• Analyze the study and determine settings and processing conditions that improve method precision and minimize bias errors. Document the desig…
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
A product developed using QbD principles will rely on manufacturing controls based on what is known to be crucial to the process. The PCS package results in a well-defined process with criticality und…
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
A fit-for-purpose facility design leveraging state-of-the-art technologies such as centralized building sensors, monitoring, and control for greater connectivity and single-pass-through air, meanwhile…
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Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
STRs offer several advantages: they are scalable and the principles by which to do so are well known, they offer precise and reproducible control of the culture conditions, and they are highly automat…
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Genetic Vaccine Platforms Demonstrate Their Potential
Moreover, the virus propagation or the production of the antigens are biochemical processes that need to be run under controlled conditions and that may take a long time (weeks to months),” Becker obs…
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High-Quality Chromatography System Meets Predesigned DeltaV for Integrated Manufacturing
Implementing a distributed control system for facility-wide control of biomanufacturing can help overcome these issues by supporting the industry with improved data management and quality control.
Article
Reimagining Affordable Biosimilars
Furthermore, adequate process controls to monitor and control product quality are necessary for receiving regulatory approval. Ultimately, this situation creates a burden on the manufacturer to invest…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
“A combination of primary (process design), secondary (facility design and operation), and procedural controls and studies should be used,” states Husain.
Stoll identifies three key approaches to …
Article
Good Manufacturing Practices: Challenges with Compliance
Cohen (Lubrizol): There are various regulations and guidelines around the world regarding the manufacture of biologics, which include information about control of feedlots and cell lines. These addres…