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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: High-throughput screening
Practical Tips: Use that software!
Posters: Surface Plasmon Resonance for MAb quantification
Multimedia Video: Single-use technologies
Webcasts: Solutions for efficient manufacturing processes
Increase your process development IQ today!
Visit http://www.processdevelopmentforum.com
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Cell-Line Development for Biomanufacturing: Considerations for Optimizing Mammalian Cell Lines
Thursday, October 27, 2011 at 8:00 AM PDT; 11:00 AM EDT
Producing high-quality therapeutic proteins depends on selecting the correct cell lines, transfection modalities and agents, and ensuring comptabilitiy between cells, transfection vectors, culture medium, and general culture conditions. This webseminar will review best practices for developing robust and high-yielding cell lines and will review the impact of those practices on process development and scale up.
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Speeding up Monoclonal Antibody Screening and Characterization
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.
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Advertiser: Dionex Products a part of Thermo Scientific
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Turning Data into Information: Making sense of an avalanche of supply chain and production data.
Biomanufacturing and operations research experts describe how to deal with staggering volumes of production and supply chain data. We describe how to consolidate and visualize this data, and then convert it into actionable information that will drive quality initiatives, find bottlenecks and improve production outcomes.
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Advertiser: Bioproduction Group
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Online LC-MS for Separation of Pharmaceutical Compounds
This method describes an automated and hyphenated LC method for the identification of pharmaceutical compounds. An SPE desalting step is applied prior to sample introduction to the MS detector, removing buffers from the eluent stream. This allows current methods to be used with MS detection without new method development.
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Advertiser: Dionex, a part of Thermo Fisher Scientific
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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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