Search results for "qbd" in Articles / App Notes
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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How To Execute Successful Data Migrations
Successful migrations require careful planning to meet business needs and maintain data integrity.
By Art Meisler
Data migration is the unglamorous task of a system implementation. …
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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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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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Understanding and Controlling Raw Material Variation in Cell Culture Media
Manage variability through advanced analytical methods and risk-based assessment.
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Article
Good Manufacturing Practices: Challenges with Compliance
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The complexity of biologics and the use of new technologies present challenges for complying with CGMPs.
By Lauren Lavelle
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