Advancing High Resolution Biopharmaceutical Analytics: Why intact mass, peptide mapping, and glycan analysis should be routine and automated across your organization
December 3, 2013 at 11:00 AM EST
This webinar will focus on advantages of using the Waters Biopharmaceutical Platform Solution with UNIFI Software to assess, monitor, and compare the critical quality attributes of innovator and biosimilar biopharmaceuticals. The speakers will look beyond the high-resolution UPLC/QTof MS data gained during an analysis, to how informatics can facilitate a better understanding of the similarities and differences between an innovator and a biosimilar product.
Register Free at www.biopharminternational.com/highres
Streamlining Recombinant Protein Manufacturing
December 12, 2013 at 02:00 PM EST
Review the common challenges with recombinant protein production from E. coli, which include protein aggregation, lengthy purification and inefficient refolding processes. A system that requires fewer purification steps and no refolding, with the goals of reducing the number of potential difficulties, lowering costs, and speeding time to market will be discussed.
Register free at: www.biopharminternational.com/streamlining
Sponsor: Ajinomoto Althea
Meeting Regulatory and Technical Requirements for Organic Impurity Analysis
Available until: October 1, 2014
Gain technical and regulatory insight for organic impurity control and analysis for pharmaceuticals. Learn from leading industry experts on selecting the appropriate analytical methods for detection, analysis, and quantification of organic impurities.
Register Free at http://www.pharmtech.com/organic
Sponsor: SGS Life Science Services
Regulatory, Biosafety, and Clinical Considerations for Vaccine Development
Available until: June 11, 2014
The development and approval processes for a vaccine requires understanding of regulatory, biosafety, and clinical issues. This webcast provides a global perspective of these key issues, plus a detailed a case study examining viral challenge testing for vaccine development in a phase I clinical pharmacology unit.
Register Free at www.biopharminternational.com/vaccine
Sponsor: SGS Life Science Solutions
Integrated Solutions for Maintaining Product Quality without Sacrificing Titer
Available until: July 17, 2014
To maintain product quality, or sacrifice titers? That is the question. Is a trade-off always necessary? This webcast will consider this age-old question and what solutions exist to help you avoid having to choose between the two.
Register Free at www.biopharminternational.com/titer
Sponsor: Life Technologies
Avoid the 483 - Unconventional Approaches to Elevate Your Quality Program
Available until: May 23 2014
Join us to learn more about unconventional approaches to enhance quality programs with the use of modern handheld technology.
Register Free at www.biopharminternational.com/ramananalysis
Sponsored by: Rigaku
New Developments in Chromatography for Improved Analytics of Biopharmaceuticals
Available until: May 14, 2014
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.
Register Free at www.biopharminternational.com/Analytics
Sponsored by: Thermo Fisher Scientific
The Basics of Biosafety Testing for Biologics
Available until: May 21, 2014
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
Register Free at www.biopharminternational.com/biosafety
Sponsored by: SGS Life Science Solutions
Challenges in Implementing ICH Q6B for Biologics Characterization
Available until: May 2, 2014
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.
Register Free at www.biopharminternational.com/ichq6b
Sponsored by: SGS Life Science Solutions
USP Outlook: Key Program Activity for 2013
Available until: April 16, 2014
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).
Register Free at www.biopharminternational.com/uspoutlook
Sponsored by: USP
High speed, high resolution characterization of biomolecules
Available until: March 5, 2014
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.
Register Free at www.biopharminternational.com/biomolecules
Sponsored by: Thermo Scientific
Improving Cell Culture Productivity: Best Practices for Automation and Control
Available until: January 29, 2014
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
Register Free at www.biopharminternational.com/culture
Sponsored by: Parker Hannifin
Leveraging the Unique Attributes of Chromatography Resins to Drive Productivity and Decrease Cost of Goods
Available until: December 12, 2013
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.
Register Free at www.biopharminternational.com/resins
Sponsored by: Life Technologies
Setting New Standards: Platform Solutions for High Quality Analytics of Process Contaminants and Impurities
Available until: November 27, 2013
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.
Register Free at www.biopharminternational.com/platform
Sponsored by: Life Technologies
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