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Featured Whitepapers:

Biomanufacturing Flexibility: Future-proofing facilities for multiple product lines and higher titers.
Learn how to create flexible, agile biomanufacturing facilities to effectively respond to facility consolidations, eroding margins and the growing need to cut costs and increase production efficiency.

» More
Advertiser: Bioproduction Group

The Power of Pulsed Amperometric Detection Coupled with Chromatography
Amperometric detectors have been around but have never become popular, mostly due to the lack of knowledge regarding function, as well as design problems with early detectors that have since been rectified. The good news is that the field is maturing and the newer equipment is rugged and easy to use.

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Advertiser: Celsis Analytical Services

Mass Spectrometry Compatible Separation of Itraconazole Substances by UHPLC
The application replicates the Chinese Pharmacopeia related substances method and shows a faster and MS-compatible UHPLC method for the separation of Itraconazole and its impurities.

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Advertiser: Dionex, a part of Thermo Fisher Scientific

Webcasts:

Cell-Line Development for Biomanufacturing: Considerations for Optimizing Mammalian Cell Lines
OnDemand Webcast

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.

» Register Free
Sponsored by: Mirus Bio LLC

Speeding up Monoclonal Antibody Screening and Characterization
OnDemand Webcast

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
Advertiser: Dionex Products a part of Thermo Scientific

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

» Listen

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.

» Listen

Using Stability Models to Predict Drug Characteristics at the End of Shelf Life
Listen to this interview with Peter Sprinz, PhD, a senior research scientist at Eli Lilly, to learn about using stability models to predict drug characteristics at the end of shelf life.

» Listen

Featured Microsite:

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: Efficient Biologics Manufacturing
Practical Tips: HETP and As testing
Posters: Purification of alpha-1 antitrypsin
Multimedia
Video: How to pack a HiScale™ column
Webcasts: Implementing QbD for biopharmaceuticals

Increase your process development IQ today!
Visit http://www.processdevelopmentforum.com

 
Sponsored by: GE Healthcare

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