Search results for " QbD"
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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Article
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…
Article
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…
Article
The Path to High-Quality Immunoassay Reagents
How Biacore surface plasmon resonance is shaping today’s assay development and selection of diagnostic reagents.
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Article
Can Vaccine Development Be Safely Accelerated?
Can Vaccine Development Be Safely Accelerated?
Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.
By Cynthia A. Ch…
Article
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
Legal experts in biopharmaceutical patent law shed some light on trends and recent news.
By Agnes Shanley
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Resource
Recovery of Biological Products XIX Conference
This international conference—taking place from July 12–17, 2020 in Rome, Italy—provides exposure to the latest developments in bioprocessing with a focus on downstream processing and aspects that aff…
Article
Biosimilar Quality Requirements
This article reviews FDA’s recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosi…
Article
Using Software in Process Validation
Using Software in Process Validation
Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.
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Article
A New Paradigm in Process Development
Accelerate biologic manufacturing of mAbs, vaccines, and novel biotherapies. Download this e-book for case studies and insights from Janssen, Roivant Sciences, and mAbxience.
Click here to downl…