Search results for "biologic"
Article
Ensuring the Biological Integrity of Raw Materials
Contamination of biologic drugs and vaccines by adventitious agents is extremely rare. However, when contamination incidents do occur, they can be costly in terms of time and resources.
In 2010, E…
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A Q&A With Günter Jagschies: Recovery of Biological Products Conference Series
Could you share your viewpoint on the importance of this meeting?
The Recovery of Biological Products is probably the meeting most relevant to scientists, engineers, and managers in the bioprocess…
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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
STEVE
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Steven Lynn, Executive Vice-President, Pharmaceuticals, Regulatory Compliance Associates, shares insight into regulatory require…
Article
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…
Webcast
Recovery of Biological Products XIX
The agenda will include progress on the state-of-the-art technologies and emerging trends in downstream unit operations for diverse biotherapeutic modalities (e.g. proteins, peptides, cell and gene …
Article
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…
Article
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…