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BIOPHARM INTERNATIONAL 2011 WEBCAST SERIES
BioPharm International is pleased to present its 2011 Web Seminar Series, addressing key issues in process development and bioprocessing. These one-hour sessions include presentations by industry experts and interactive dialogue with the audience. Watch live and participate in the Q&A, or catch them later on demand. |
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Highly useful bioprocess information online
Introducing a new BioPharm International web site featuring practical tips and technical insights for the entire process development spectrum. Check out these latest fresh topics:
Articles/App Notes: Selecting normal flow filters
Practical Tips: Choosing columns
Posters: Process control in a disposable bioreactor
Multimedia Video: Liquid chromatography system
Webcasts: Purification and single-use technologies
Increase your process development IQ today!
Visit http://www.processdevelopmentforum.com
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Webcasts: |
QbD and Me: How to implement ICH Q10 in Biomanufacturing
Bio-G Webinar: 1:00PM Pacific, July 14, 2011
How do Quality by Design principles actually get implemented on the manufacturing floor? In this webinar, we show how to take QbD off the 'drawing board' and actually implement these ideas that make a measurable difference to biomanufacturing quality. We focus on specific tools, including:
- Statistical process and quality control measurements (SPC and SQC)
- 'Golden batches' for continuous time measurements like pH in a bioreactor
- Correlating process parameters with quality outcomes and how this can drill down on 'critical' vs non-critical measurements
- Multi-unit operation correlation to show how a process variation impacts processes and quality downstream
We also look at how to integrate and visualize this data from multiple sources in a single system - including DeltaV, PI, etc. - without a 6-figure capital outlay. This webinar is designed for quality engineering, manufacturing science, operational excellence and other groups interested in maximizing manufacturing quality in their organizations.
Please register to attend this event at: http://info.bio-g.com/webinar/qbdandme.html
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Speeding up Monoclonal Antibody Screening and Characterization
August 31, 2011 at 11:00 AM EDT
Monoclonal antibodies (MAbs) are highly specific for their targets, induce few side effects, and have a relatively long half life. They have found commercial success in treating a variety of indications, including cancer and autoimmunity.
With the increase in commercial importance, regulatory agencies now demand more clearly defined methods for characterizing MAbs to ensure safety and efficacy. Pharmaceutical companies invest hundreds of millions of dollars annually in analytics and QC programs. Size and charge heterogeneity rank among the most crucial attributes to monitor throughout the product development process as part of the quality-by-design (QbD) paradigm. The sheer numbers of samples that need to be processed as a result of this growing pipeline and QbD implementation in a short period of time has put upward pressure on the industry to invest and innovate in an analytical support infrastructure that features high sample throughput and a high degree of automation.
This webinar discusses current regulatory and operational challenges. Also presented are developments in LC-based analytical tools that help increase performance, throughput, and productivity of MAb characterization to reduce cost and development time.
» Register Free |
Sponsored by: Dionex part of Thermo Fisher Scientific
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Featured Whitepapers: |
Keys to reducing time-to-market
With development times measured in years, increasing costs represent a major challenge confronting pharmaceutical and biotechnology companies. As a result, reducing time-to-market is an essential component in any business strategy.
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Advertiser: Vetter Pharma International GmbH
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Increased Load of DNA-Based Oligonucleotide on TSKgel SuperQ-5PW (20) Resin
Oligonucleotides are now entering clinical trials in greater numbers. Their purification requires the use of a high resolution resin to isolate the target from the N-1 and N+1 impurities. This white paper demonstrates the use of TSKgel SuperQ-5PW (20) resin under higher loading conditions to purify with the high yield target oligonucleotide.
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Advertiser: Vetter Pharma International GmbH
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Podcasts: |
A Conversation with BIO's Jim Greenwood
Jim Greenwood comments on the state of innovation in the bio/pharmaceutical industry and discusses policies that could help move promising technologies out of discovery and into development. Podcast interview by Editor Director Michelle Hoffman
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Answers to Your Questions about QbD
Hundreds of listeners tuned into our recent web seminar on Quality by Design, and we didn't have time to answer all their questions. Fortunately, our speakers gathered to answer the common questions in this podcast. Listen to hear their views.
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The Current State of Supply Chain Security: An FDA Perspective
In this interview, Richard L. Friedman, Director of the Division of Manufacturing & Product Quality in the Center for Drug Evaluation and Research, FDA's Office of Compliance discusses the progress made so far in executing supply chain security programs.
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