Search results for " approval" in Articles / App Notes
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Optimizing Drug Safety and Efficacy of Complex Next-Generation Biologics
In recent years, the global biopharma industry has seen a rapidly advancing trend toward biotherapeutics or ‘biologic’ drugs—drugs that are produced from living organisms or contain components of li…
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Tips for Viral Vector Production
The viral vector market is highly active, and the interest in production technologies is driven by recent approvals in cell and gene therapy. In this blog article, insights are shared around the cha…
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Getting it Right from the Start in the Drug Development Process
Proper process understanding allows researchers to critically identify factors that impact the drug substance and product as well as minimize or maintain them at approved levels. As a result, the de…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
By Feliza Mirasol
With the recent FDA approvals and commercialization of cell and gene therapies in the US market and a pipeline of cell and gene therapies progressing toward regulatory review, …
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Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
natali_mis/Stock.Adobe.com
Regulators have been en…
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The Good and Bad of Biosimilars
Today, however, the competition is really beginning to heat up, with a rising tide of new biosimilar approvals coming from both established companies and new players, including companies in emerging m…
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Nurturing Knowledge from Disparate Data Streams
Overcoming these challenges will dramatically improve researchers’ abilities to make faster decisions and will ultimately accelerate drug development and approval, she adds.
Analytical manufact…
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Advances in Engineering of Protein-Based APIs
Advances in Engineering of Protein-Based APIs
New platform technologies, advanced modeling tools, and addressing patient needs are important developments.
By Cynthia A. Challener
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Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics
Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
By Anurag S. Rathore, Rohit Bansal
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Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
Interest in Cutting-Edge Therapies Continues to Grow
With FDA’s first approvals of cell and gene therapies now more than a year old, activity in these areas shows no signs of slowing down. Proce…