Best Practices for Effective Environmental Monitoring Program in Bio/Pharmaceutical Production
Tuesday, April 22, 2014; 11 am-noon Eastern US time and Tuesday, April 29, 10:00-11:00 Central European time
Contamination poses a threat to process and product integrity, as well as patient safety. A comprehensive environmental monitoring program can ensure that manufacturing areas, cleanrooms, production equipment, and water and gas utilities are free of viable and non-viable contamination and meet regulatory requirements. In this webcast, learn about pertinent regulatory and quality standards, as well as best practices for establishing and maintaining an effective environmental monitoring program. Review measures for testing pharmaceutical water systems according to U.S. Pharmacopeial Convention (USP) water monograph as well as procedures to evaluate the purity of production gases.
Register free at www.pharmtech.com/emp
Sponsored by SGS Life Science Services
Fast, Robust LC and LCMS Workflows for the Comprehensive Characterization of Bio-Therapeutic Proteins
Wednesday, June 3, 2014: 8:00 am PDT/ 11:00 am EDT/ 4:00 pm BST/ 5:00 pm CEST
Would you like to reduce method development time for mAb characterization from weeks to minutes? Have finalized methods that are more robust than previous methods? The webinar will describe new technology and workflows for mAb characterization with advice on simplified method development..
Register free at www.biopharminternational.com/fast
Sponsored by Thermo Fisher Scientific
Increase Control over Quality Management Through Strong Supplier Relationships
Available until: April 2, 2015
Understand the regulatory obligations of bio/pharmaceutical companies in a global, outsourced supply chain and challenges with building effective supplier relationships. Learn how a supplier quality management system should provide the ability to aggregate quality metrics in a consistent, measurable, normalized, and repeatable way.
Register free at www.pharmtech.com/relationships
Sponsored by Sparta Systems
Navigating the Analytical Development Challenges for Bioprocess Residuals and Impurities
Available until: April 1, 2015
Tracking the clearance of host cell components and process additives residuals is an essential part of process development and characterization of biopharmaceuticals.
In this webinar, learn about challenges presented by residuals, regulatory expectations, analytical approaches for cell- and process-associated residuals, a platform method technology for residuals, and matrix effects.
Register free at www.pharmtech.com/navigating
Sponsored by Eurofins Lancaster Laboratories
Identifying, Analyzing, and Controlling Particles throughout the Biopharmaceutical Product Lifecycle
Available until: March 25, 2015
Preformulation screening can identify potential problems and form the basis for long-term stability of biopharmaceutical drug products. One of the main challenges in the development of stable biopharmaceutical products is the control of aggregation and particulate formation. Review how particles can potentially develop through the life cycle of a drug, understand regulatory expectations, and assess analytical techniques available to assess protein aggregation and particulates for innovator drugs and biosimilars.
Register free at www.biopharminternational.com/particles
Sponsored by SGS Life Science Services
Streamlining Recombinant Protein Manufacturing
Available until: December 12, 2014
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
Advancing High Resolution Biopharmaceutical Analytics: Why intact mass, peptide mapping, and glycan analysis should be routine and automated across your organization
Available until: December 3, 2014
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
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
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