Search results for "regulatory"
Article
Process Development: 2020 Reflections and 2021 Possibilities
The challenges posed by the COVID-19 pandemic in 2020 brought about many unprecedented lessons and promising developments in the biopharmaceutical industry. Last year in particular reenforced the ne…
Article
Manage HCPs and Enhance Your Route to Market
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Host cell protein (HCP) management is critical to biologics development—and getting it wrong could delay your development cycle. Learn how the right HCP strategy can e…
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Advancing Future Therapeutics
Join our live process intensification webinars.
Article
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…
Article
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.
Article
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…
Article
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…
Article
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…
Article
Towards a Better Process Outcome
Considerations for improving outcome in biopharmaceutical process development.
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