Biosimilars: Structural Characterization and Comparability Approaches
April 26, 2012 - 11:00 AM EDT
This webinar will provide information on how to approach biosimilar characterization and comparability to originator molecules based on the US Biologics Price Competition and Innovation Act and on the current European regulatory pathway for biosimilars.
Register Free at www.biopharminternational.com/structural
Gillian Woollette, Chief Scientist, Engel and Novitt
Fiona Greer, PhD, Global Director, BioPharma Services Development, SGS M-Scan
Challenges and Opportunities in Biopharmaceutical Higher Order Structure and Conformation Stability Analysis: A Focus on HDX Applications
March 27, 2012 - 10:30 AM EDT
Regulators are encouraging the biopharmaceutical industry to improve biophysical characterization of protein therapeutics when performing drug safety evaluations. This is especially important for higher order structure integrity, conformation stability, and epitope mapping, all crucial steps for therapeutic antibody characterization. However, previously there was no widely available, high-resolution analytical method to characterize protein therapeutics in solutions. Hydrogen/deuterium-exchange mass spectrometry (HDX-MS) has become increasingly popular with academia investigating protein dynamics, as well as protein-ligand and protein-protein interactions. Recent development of automation and data-extraction software enables the application of HDX-MS to protein characterization in the biopharmaceutical industry. Several companies have used or are considering using HDX-MS data for their regulatory agency filings. This webinar will detail the fundamentals of HDX-MS and its application to biopharmaceutical development.
Register Free at www.biopharminternational.com/hdx
Sponsored by: Thermo Fisher Scientific
Reducing the host cell DNA quantitation bottleneck:
Approaches for improved sample preparation and throughput
Recorded on: December 6, 2011
Because of the low sample throughput typical of most quantitative DNA assays, host cell DNA quantitation can become an analytical bottleneck during process characterization. In this presentation, speakers will discuss a quantitative polymerase chain reaction (qPCR) based system for highly sensitive, accurate quantitation of residual host-cell DNA from Chinese Hamster Ovary (CHO) cells, which are widely used in the production of biopharmaceutical products.
Register Free at www.biopharminternational.com/hostcelldna
Sponsored by: Life Technologies Corporation
Techniques & Tools for Improving Productivity by Automating Control of Bioseparations
Recorded on: December 8, 2011
In this educational webinar, speakers will consider the challenges faced by biopharmaceutical laboratories today. We’ll discuss techniques to improve analytical methods for bioseparations by automating control of pH. Tools that can increase productivity and improve the robustness and reproducibility will be discussed, including how they can be used when paired with UPLC.
Register Free at www.biopharminternational.com/tools
Sponsored by: Waters Corporation
Optimize Downstream Purification Processes: New Approaches and Benefits to Bioprocess Chromatography
Recorded on: December 14, 2011
Learn how high capacity, high resolution and salt tolerant ion-exchange (IEX) resins can help revolutionize your approach to bioprocess chromatography. An expert will demonstrate the benefits of IEX resins to downstream purification processes, including increased process flexibility and productivity while providing high impurity clearance.
Register Free at www.biopharminternational.com/optimize
Sponsored by: Life Technologies Corporation
Cell-Line Development for Biomanufacturing: Considerations for Optimizing Mammalian Cell Lines
Recorded on: October 27, 2011
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 at www.biopharminternational.com/cell-line
Sponsored by: Mirus Bio LLC
Speeding up Monoclonal Antibody Screening and Characterization
Recorded on: August 31, 2011
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 at www.biopharminternational.com/characterization
Sponsored by: Dionex Products a part of Thermo Scientific
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