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SGS, in collaboration with Biopharm International and PharmTech, are now offering the following webinars for on demand viewing.

Identifying, Analyzing, and Controlling Particles throughout the Biopharmaceutical Product Lifecycle

Biopharmaceuticals need a stable environment to ensure a long product shelf life. One of the main challenges in the development of stable biopharmaceutical products is the control of aggregation and particulate formation. This 60-minute webcast will discuss the mechanisms and processes through which aggregation can occur and ways in which product development teams can investigate particulate formation and its control through early stage formulation development. Experts will discuss how particles can potentially develop through the life cycle of a drug, describe regulatory expectations, and provide a review of analytical techniques available to assess protein aggregation and particulates for innovator drugs and biosimilars. A case study will demonstrate real-world examples of how particulates levels can be higher than expected when preformulation screening is not properly conducted.

Key Learning Objectives:

  • Review regulatory expectations and industry concerns about protein aggregation
  • Assess the advantages and disadvantages of analytical techniques for measuring particles
  • Understand how particles develop during a drug’s lifecycle

View this on-demand webinar.

 

Best Practices for Effective Environmental Monitoring Program in Bio/Pharmaceutical Production

In a bio/pharmaceutical production facility, contamination is a potential threat to process and product integrity, as well as patient safety. For acceptance testing, validation, or routine monitoring, 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 60-minute webcast, the audience will learn about pertinent regulatory and quality standards, as well as best practices for establishing and maintaining an effective environmental monitoring program for a bio/pharmaceutical production facility.

An expert will review measures for testing pharmaceutical water systems according to U.S. Pharmacopeial Convention (USP) water monograph and other standards. In addition, critical test procedures to evaluate the purity of production gases (compressed air, oxygen, nitrogen and carbon dioxide), as well as particle, microbial, dew point, and residue testing will be reviewed.

Key Learning Objectives:

  • Understand regulatory requirements and guidance for controlling contamination in bio/pharmaceutical production facilities
  • Review testing procedures for evaluating bio/pharmaceutical production water and gas systems
  • Evaluate your facility’s environmental monitoring program and develop strategies for improvement

View this on-demand webinar.

 

Effective Viral Contamination Testing Programs for Biologics Product Manufacturing

Viruses pose a threat at all stages of the biopharmaceutical manufacturing process from raw materials, to cell lines and cell culture, through bulk harvests and biomanufacturing. Biopharmaceutical manufacturers need comprehensive virus testing programs to ensure product safety throughout the various manufacturing stages.

In this webcast, experts will describe strategies and best practices for developing and implementing effective virus testing programs, including a review of regulatory guidance. In addition, participants will learn about test methods for virus detection and quantitation during various biopharmaceutical manufacturing phases. A range of testing technologies, including in vitro adventitious virus assays, PCR, ELISA, plaque assays, and electron microscopy, as well as sampling methods, will be discussed.
The panelists will provide an analysis of the advantages and limitations of each method, as well as methods that are most suitable for specific situations.

Key Learning Objectives:

  • Develop a comprehensive plan for effective testing for viral contaminants
  • Review current testing methods and revise current methods to ensure product safety
  • Understand pros and cons for various methods for detecting viruses

View this on-demand webinar.