BioPharm International is pleased to present its 2010 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.

Extractables & Leachables Testing for Single-Use Bioprocessing Equipment Assessing Risk, Leveraging Knowledge, and Protecting Patients
Tuesday, March 23, 2010 at 11:00 AM ET

As the biopharmaceutical industry’s adoption of single-use bioprocessing equipment continues to increase, end-users continue to have questions about how to obtain extractables and leachables data that ensures patient safety, meets regulatory expectations, and is appropriately scaled to the true levels of risk. This session will explain the sources of extractables and leachables from plastics and elastomers, present the updated Bio-Process Systems Alliance (BPSA) guide to conducting extractables and leachables testing, and outline risk-based approaches to assessing the impact of extractables and leachables on product quality and structuring an E&L program to address those risks..

Register Free at www.biopharminternational.com/EandL

Quality by Design in Biotech: Keys to Implementation
Tuesday, June 8, 2010 at 11:00 AM ET

As the biopharmaceutical industry’s adoption of single-use bioprocessing equipment continues to increase, end-users continue to have questions about how to obtain extractables and leachables data that ensures patient safety, meets regulatory expectations, and is appropriately scaled to the true levels of risk. This session will explain the sources of extractables and leachables from plastics and elastomers, present the updated Bio-Process Systems Alliance (BPSA) guide to conducting extractables and leachables testing, and outline risk-based approaches to assessing the impact of extractables and leachables on product quality and structuring an E&L program to address those risks..

Register Free at www.biopharminternational.com/series2

Addressing the Challenges of Downstream Processing, Today and Tomorrow
Tuesday, September 21, 2010 at 11:00 AM ET

As upstream titers continue to improve, companies need solutions to ensure that cell culture gains are not lost in a downstream bottleneck. This web seminar will share data on new strategies and disruptive technologies that can streamline current processes and facilitate productivity, as well as improvements in traditional unit operations.

Register Free at www.biopharminternational.com/series3

Characterizing Protein Products: Critical Questions and New Technologies
Thursday, November 11, 2010 at 11:00 AM ET

Protein characterization has always been critical for setting product specifications, determining process controls and release tests, and for establishing comparability after scale-up or site changes. Today, the analysis of protein structure has become even more important, given its key role in the debate over what constitutes “similarity” for biosimilar molecules. This seminar will analyze accepted and emerging methods for protein characterization, including the strengths and weaknesses of the methods and their use in regulatory filings.

Register Free at www.biopharminternational.com/series4

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