Search results for " industry"
Article
A Q&A With Jeff Carter on Trends in Single-Use Technologies
What general trends do you see in single-use technologies within the biopharmaceutical industry?
We are now seeing standardization of materials testing data and corresponding analytical techniques…
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Tools for Continuous Bioprocessing Development
The ability to codify manufacturing into robust design rules has had a tremendous impact on the semiconductor industry, and enabled it to move from a simple vertically integrated model where manufactu…
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Mechanistic Modeling: Does it Have a Future in Process Development?
Could you tell more about your experience?
A couple of years ago, CDER invited industry for partnerships for discussions on how to prepare an application using QbD. Then representatives of CBER app…
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
The period of 2005-2008 was more about the industry and academia trying to understand what QbD is and what the underlying concepts meant. The years 2008-2012 were more about implementing QbD with the …
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Challenges in Analytical Method Development and Validation
While the biopharmaceutical industry has had success in reducing risk by incorporating analytical platform technologies for monoclonal antibody products, new molecules and drug conjugates pose additio…
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Bureaucratic Roadblocks Threaten Biopharma Growth
Patent uncertainty abroad
The Biotechnology Industry Organization (BIO) is concerned over a series of patent revocations including a decision by India’s Supreme Court to deny patent protection fo…
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Biopharma Outsourcing Activities Update
Industry outsourcing more than ever
This year, if respondents follow through on their outsourcing plans, an even more influential dimension in the biopharmaceutical manufacturing industry can be ex…
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Bioprocessing Advances in Vaccine Manufacture
The vaccine industry, particularly, in major Western markets, continues to be dominated by a few major, long-established players that primarily manufacture aging, long-marketed, non-recombinant (nonge…
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FDA Seeks Metrics to Define Drug Quality
Achieving drug quality has become more complex--and more vital--with industry globalization, she acknowledged, emphasizing the importance of manufacturers producing quality products batch after batch.…
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Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
Topics covered include:
1:47 - Where the industry is headed with real-time analysis
3:17 - Scaling up
4:57 - Cell perfusion
7:16 - Criti…