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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. |
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Tuesday, March 23, 2010 at 11:00 AM ET
Extractables & Leachables Testing for Single-Use Bioprocessing Equipment
As the biopharmaceutical industry’s adoption of single-use bioprocessing equipment continues to increase, endusers
continue to have questions about how to conduct extractables and leachables testing in a way 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.
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Tuesday, June 8, 2010 at 11:00 AM ET
Quality by Design in Biotech: Keys to Implementation
Applying the concepts of Quality by Design to the manufacture of biotech products involves some nuances and
complexities. This web seminar will provide guidance for implementing QbD with biopharmaceuticals, including
recommendations from the QbD Working Group of the PhRMA Biologics and Biotechnology Leadership Committee
and industry case studies of applying QbD to various steps of process development for different unit operations.
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Tuesday, September 21, 2010 at 11:00 AM ET
Addressing the Challenges of Downstream Processing, Today and Tomorrow
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.
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Thursday, November 11, 2010 at 11:00 AM ET
Characterizing Protein Products: Critical Questions and New Technologies
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.
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| Featured Podcasts: |
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UPLC, QT of, HDMS, and more: A practical guide to the hottest techniques driving the future of biopharmaceutical science
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Episode Number 3: Advances in glycan analysis
In this podcast series, we'll provide you with a firm knowledge of the latest technological innovations in LC and LC/MS that have been designed to address and advance the very specific needs of the many applications areas in the biopharmaceutical laboratory.
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