Search results for " quality"
Article
Can You Trust a Machine for Downstream Bioprocess Buffer Preparation?
Some of the questions to be answered are:
- Can automated buffer management solutions save resources and maintain the quality?
- Is automated buffer preparation a solution to the dilemma …
Article
Free On-Demand Webinar: Smart Process Development of Chromatography Steps
Smarter development of chromatography processes reduces timelines and improves outcomes.
Smart process development is a collection of approaches to improve and speed up process development—prov…
Article
Tools and Processes for Mature and Emerging Therapies
New technologies for aseptic processing—a frequent source of quality problems—were in evidence at INTERPHEX. To control contamination threats during transfer and fill/finish steps for bulk, vial, and …
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Webinar On-Demand: Novel Analytics to Improve Bioprocessing and Validation Guideline
At the recent Biotherapeutics Analytical Summit, Fredrik Sundberg presented the importance of implementation of a robust analytical control strategy to ensure drug product efficacy and patient safet…
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Scale-Up Model of a mAb Process from Microbioreactor to XDR-1000
All investigated bioreactor systems displayed similar trends over time and acceptable variability between cultures for viable cell density and viability profile, product titer, lactate, and product qu…
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Single-Use for Downstream Chromatography: Benefit or Hindrance?
“Drug producers have to sample for quality and process control purposes many, many times continuously. Typically, to effectively sample, you sample more than what is needed, and, in some cases, it isn…
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Successfully Moving Regulated Data to the Cloud
Instead of the user and/or quality assurance reviewers needing to ‘hunt’ for deviations by looking at all of the data captured in a paper record, electronic systems can be configured to provide automa…
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Protein Analysis with Size Exclusion Chromatography
Size exclusion chromatography (SEC) is widely used in several different analytical applications from basic research to quality control of biotherapeutics. This white paper presents fundamentals abou…
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Advances in Engineering of Protein-Based APIs
New strategies are also being applied to the development of engineered proteins that integrate developability prediction, manufacturability assessment, and quality-by-design early in the process. “Thi…
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Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics
Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
By Anurag S. Rathore, Rohit Bansal
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