Search results for "regulatory" in Articles / App Notes
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ISPE Releases Cleaning Validation Guide
ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.
The International Society for Pharmaceutical Engin…
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DiPIA online
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Biacore surface plasmon resonance application specialists are eager to share their experience in assay design, validation, and data evaluation.
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EMA Confirms Standards for COVID-19 Treatment Evaluations
The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicine…
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Highlights from the 5th International HTPD Conference, Part 3: Smart Process Development and a Look into the Future
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The high-throughput process development (HTPD) conference series is the key international forum for the presentation and discussion of topics relevant t…
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Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
What do you think, how will in silico solutions influence regulatory requirements such as risk management or process characterization under the QbD-paradigm?
We are already observing a change that…
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Highlights from the 5th International HTPD Conference: Part 2
Applications of modern high-throughput process development
The high-throughput process development (HTPD) conference series is the key international forum for the presentation and discussion o…
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Towards a Better Process Outcome
Considerations for improving outcome in biopharmaceutical process development.
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Understanding and Controlling Raw Material Variation in Cell Culture Media
Manage variability through advanced analytical methods and risk-based assessment.
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Step Up to GMP Manufacturing or Outsource to a CDMO: Considerations and Tips
Whether you are developing a new monoclonal antibody (mAb), cell therapy, gene therapy, or large-molecule biologic drug, the decision to tackle GMP manufacturing in-house or work with a contract devel…
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Robust Business Continuity Program Helps to Maintain Operations in the Face of Crisis
As we began 2020, no one could have foreseen that just a few weeks into the year, we would be facing a pandemic threatening unprecedented damage to human health and the world economy. Businesses are…