Webcasts - BioPharm International

Webcasts

LIVE WEBCASTS

New Developments in Chromatography for Improved Analytics of Biopharmaceuticals
Tuesday May 14, 2013; 8:00 am PDT, 11:00 am EDT, 16:00 GMT

Therapeutic proteins and monoclonal antibodies have transformed the biopharmaceutical industry and form the largest part of the rapidly growing biotherapeutics and biosimilars drug market. Essential to their development is the ability to quickly and accurately assess product quality and safety—including factors such as sequence integrity, titer, aggregation, charge, and glycan heterogeneity and purity—at each step. Biosimilars, which require extensive comparison to their reference products, have placed further demands on state-of-the-art analytical techniques to assess comparability and similarity.

New workflow-based analytical tools for protein analysis enable these assessments early in the development process. They provide insights that allow better, faster decisions on how to proceed with your development. This webinar will discuss new advances in state-of-the-art chromatography and mass spectrometry solutions used to support characterization, comparability, similarity, and stability studies required during biotherapeutic and biosimilar drug development and QA/QC. Learn about the new Bio-UHPLC platform and consumables for charge variant and glycan analysis.

Sponsor: Thermo Fisher Scientific

The Basics of Biosafety Testing for Biologics
Tuesday, May 21, 2013 at 11AM EDT for the US and Tuesday, May 28, 2013 at 3PM CET for Europe

Detection and control of adventitious agents during the production of biologic products is a crucial part of the biomanufacturing process. Learn about regulatory concerns, biosafety challenges, historical contamination events, and the pros and cons of various testing methods to detect adventitious agents

Sponsor: SGS Life Science Solutions

Avoid the 483 - Unconventional Approaches to Elevate Your Quality Program
Thursday, May 23 2013; 8:00 am PDT, 11:00 am EDT

Join us to learn more about unconventional approaches to enhance quality programs with the use of modern handheld technology.

Sponsor: Rigaku

ON-DEMAND WEBCASTS

Challenges in Implementing ICH Q6B for Biologics Characterization
Recorded on: Thursday, May 2, 2013 at 11AM EDT for the US and Thursday, May 9, 2013 at 3PM CET for Europe

ICH Q6B outlines the requirements for biologics characterization. This webcast will help drug developers keep pace with new and evolving analytical techniques meet the challenges of determining higher-order structure and analyzing glycosylation of biologics products.

Sponsored by: SGS Life Science Solutions

USP Outlook: Key Program Activity for 2013
Recorded on: April 16, 2013

Learn from USP experts, including, Todd Cecil, PhD, USP’s Vice-President of Compendial Science, on USP’s key program activity for 2013. Gain expert insight on the Monograph Modernization progress, New General Chapter content for Excipients, Analysis of Elemental Impurities, Microbiology, and the Medicines Compendium (MC).

Sponsored by: USP

High speed, high resolution characterization of biomolecules
Recorded on: March 5, 2013

Biomolecules such as monoclonal antibodies, proteins, and oligonucleotides are increasingly being developed by pharmaceutical and biotechnology companies for a wide range of therapeutic applications. Variations in the composition of these highly complex biomolecules can dramatically affect their activity and stability as a biotherapeutic. Monitoring the stability of therapeutic biomolecules is consequently regarded as essential for demonstrating the safety and efficacy of these biologic drugs, and is expected by the FDA and other regulatory agencies.These regulatory guidelines are likely to become stricter in the coming years and with cost containment measures expected to make a greater impact on biotechnology, the requirement for faster, more efficient characterization of biotherapeutics will become even more crucial.

Many stationary phases have been developed to deliver high resolution separations of biomolecules. Just as for small molecules, significantly faster characterization of biomolecules can be achieved using columns of shorter format and smaller particle size while maintaining the same high resolution of longer column formats. In this webinar, the use of smaller particles for high resolution and high speed variant analysis is presented.

Sponsored by: Thermo Scientific

Improving Cell Culture Productivity: Best Practices for Automation and Control
Recorded on: January 29, 2013

This webcast will provide insight into how automated systems and quality control measures can help to improve cell culture productivity and optimize upstream processes.

Explain good/better/best solutions
Reduction in manual operations and error
Method to analyze manual process and determine automation risk factors

Sponsored by: Parker Hannifin

Leveraging the Unique Attributes of Chromatography Resins to Drive Productivity and Decrease Cost of Goods
Recorded on: December 12, 2012

Learn how high performance chromatography resins can help revolutionize your downstream process. An experienced industry representative will demonstrate how chromatography can drive improved productivity and product yields and enhance impurity clearance, all which drive lower cost of goods.

Sponsored by: Life Technologies

Setting New Standards: Platform Solutions for High Quality Analytics of Process Contaminants and Impurities
Recorded on: November 27, 2012

This webinar will describe an integrated platform of rapid, highly sensitive in-process testing methods that deliver industry-leading solutions for contaminant and impurity detection and quantitation.

Sponsored by: Life Technologies

Top Trends in Laboratory Instrument Compliance
Recorded on: November 7, 2012

Learn about the latest trends in and best practices for meeting global laboratory instrument compliance.

Sponsored by: Agilent

Critical Quality Attributes for Monoclonal Antibodies
Recorded on: September 25, 2012

This webinar will discuss the challenges associated with applying a QbD approach to biopharmaceuticals, namely monoclonal antibodies, including how to best determine CQAs and meet pending regulatory expectations when developing and manufacturing these complex drug substances.

Sponsored by: SGS Life Science Services

Biosimilars: Structural Characterization and Comparability Approaches
Recorded on: April 26, 2012

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.

Sponsored by: SGS Life Science Services

Challenges and Opportunities in Biopharmaceutical Higher Order Structure and Conformation Stability Analysis: A Focus on HDX Applications
Recorded on: March 27, 2012

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.

Sponsored by: Thermo Fisher Scientific

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