Search results for " drug" in Articles / App Notes
Article
Process Development: 2020 Reflections and 2021 Possibilities
Shrinking timelines and an increasing number of drug candidates and corresponding experiments makes these approaches more necessary than ever. One efficient method is high-throughput process developme…
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EMA Confirms Standards for COVID-19 Treatment Evaluations
In the letter, the agency details steps to ensure a separation between persons giving scientific advice to a drug developer and persons evaluating a market authorization application. The letter states…
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Meeting the Process Development Challenges of a Diverse Biologic Pipeline
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Understanding the challenges novel and diverse biological molecules can create and how to manage these challenges is key to ensuring they reach patients safely and eff…
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Controlling Cell Culture Process Variability Through Supplier-Enabled Data Management and Analytics
In drug development and manufacturing, variability in raw materials presents high risks to the success of processes and products. When raw material variability issues arise, manufacturers and supplier…
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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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Case Study: High Throughput mAb Purification Using Fibro
In this case study, a drug discovery lab at AstraZeneca finds that purifying antibodies with Fibro PrismA means they can screen more candidates per week with a simpler equipment setup.
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Five Reasons for Outsourcing Chromatography Resin Lifetime Studies
Resin lifetime studies are a regulatory requirement for new drug application (NDA) filing. But are running these lengthy and repetitive studies the best use of your process development time? Discove…
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The Evolution of Supply Chain Security: Increasing Focus on Raw Material Variability
An increase in the development of biological and patient-specific drugs has also reinforced the demand for heightened raw material control.
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
By establishing effective management of data and knowledge, it will be possible to employ advances, such as artificial intelligence and synthetic biology, to their full potential in upstream bioproc…
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Mapping a Route for Cell and Gene Therapy Process Development
While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.
By Cynthia A. Challener
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