Search results for " biologics" in Articles / App Notes
Article
Ensuring the Biological Integrity of Raw Materials
(2,3)
Global regulations, including those from the United States Department of Agriculture, the European Medicines Agency, and the FDA’s Center for Biologics Evaluation and Research (CBER) set sta…
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A Q&A With Günter Jagschies: Recovery of Biological Products Conference Series
Process Development Forum speaks with Günter Jagschies, Cytiva, who is sitting on the organizing committee for the Recovery of Biological Products XVII Conference, which will take place June 19-24, …
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Meeting the Process Development Challenges of a Diverse Biologic Pipeline
While these novel biologics are filling drug pipelines, they are also challenging existing manufacturing processes in upstream, downstream, and analytical development.
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Current Trends in Host Cell Protein Detection for Biologics Manufacturing
Commonly accepted HCP analytical methods, the challenges of HCP assay, and recommendations on what can easily be accomplished in-house and when it may be better to outsource.
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Developing a New Biologic Drug: Regulatory Challenges and Considerations
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Key milestones and planning ahead for compliance when bringing a new biologic drug to market
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
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Steven Lynn, Executive Vice-President, Pharmaceuticals, Regulatory Compliance Associates, shares insight into regulatory require…
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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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Emerging biopharma: progressing a biologic drug to market
There are many pitfalls in the road to developing and bringing a new therapy to market. Understanding some of these areas and being prepared to make the right decisions at the right ti…
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The Need for Advanced Process Modeling for New Therapeutic Biologics
The Need for Advanced Process Modeling for New Therapeutic BiologicsThe trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling e…
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Being Thorough When Transferring Technology
By Susan Haigney
Editor's note: The following is an extended version of the article published in the print version of BioPharm International's March 2017 issue:
Tech transfer and scale up of b…