Search results for " compliance" in Articles / App Notes
Article
Viral Clearance Challenges in Bioprocessing
“Good facility design and strict compliance with good manufacturing practice is the best approach to avoiding this problem,” he says. Equipment and process failures, such as inadequate raw material sc…
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Challenges in Analytical Method Development and Validation
Technologies, such as FDA’s quality-by-design (QbD) initiative, may have a positive impact on analytical method development and validation according to Paul Smith, EMEAI laboratory compliance producti…
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Raw Material Variability
Raw material variability may lead to quality compliance issues, process inconsistency, or bioprocess productivity problems. Many of these issues would be upstream in the cell-culture or fermentation s…
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The Lifecycle Change of Process Validation and Analytical Testing
BioPharm International spoke with Hal Baseman, COO and principal at ValSource LLC and co-leader of the Parenteral Drug Association Process Validation Interest Group; Paul Smith, EMEAI laboratory compl…
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Introducing the VH3 ligand ELISA kit
Accurate testing for ligand leakage from affinity resins is a key part of this process, ensuring compliance with regulatory standards.
Our new VH3 ligand ELISA kit - the latest addition to Cytiva…
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Getting your investigational drug regulatory ready
Navigating regulatory requirements can be an overwhelming and time-consuming part of the translational journey. From the submission of an investigational new drug (IND) application, regulators…
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Digitalization: The Route to Biopharma 4.0
Adhering to regulatory compliances is critical during biopharma manufacturing. One of the critical FDA guidance documents that applies to digitalization efforts is that of Part 11 of Title 21 of the C…
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Pulling Out All the Stops in mAb Manufacturing
The need for good manufacturing practice compliance for mAbs going forward is increasingly crucial.
Learn more here
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Using Digital Twins to Model Process Chromatography
…e standard approach for improved process performance, intensified development, and quality-by-design compliance.
Additionally, mechanistic modeling has an ever-growing research and development pi…
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Cell-free Expression Systems Pose Cell Culture Alternative
…e extracts and products at scale as well as having several products in clinical trials for which GMP compliance has been demonstrated, the professors state. Meanwhile, LenioBio, a Germany-based biote…