Search results for " industry 4.0"
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Managing Risk in Biomanufacturing
We simply cannot avoid all risks and the stakes are high in the biopharmaceutical industry. With patients’ lives dependent on a continuous supply of high-quality drugs and vaccines, it is essential …
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Fusion Proteins Pose Manufacturability Challenges
The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues.
By Cynthia A. Challener
Fusion proteins are engineered proteins that contain domains from di…
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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…
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Speed and Flexibility Are Dual Goals for Biopharma Operations
Bioprocessing facilities, equipment, and materials, as well as strategies to improve biopharmaceutical development and manufacturing, were featured at INTERPHEX 2017, held in March in New York City.…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
By Catherine Shaffer
Four biosimilars have been approved for the market by FDA as of February 2017, and more are in the pipeline. Now that biosimilars are here to stay, manufacturers are devel…
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Single-use Bioreactors Have Reached the Big Time
The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.
By Cynthia A. Challener
Single-use bioreactors available from various vendors…
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Reconciling Sensor Communication Gaps
By Angelo DePalma, Ph.D.
Process analytical technology (PAT), quality by design, and individual company- or process-centric quality initiatives are driving the development of bioprocess sensors …
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Single-Use Extractables and Leachables: Cytiva's Alignment with the BPOG Protocol
Despite years of discussion and experience, E&L testing approaches for single-use equipment have not yet fully matured into a consensus industry practice. Copious amounts of data have been generated…
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Establishing Acceptance Criteria for Analytical Methods
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.
By Thomas A. Little, PhD
To control the consistency and quality o…
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Real Time Continuous Microbiological Monitoring
Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.
By Claudio Denoya …