Life Science On-Demand Webinars
In 2014 SGS hosted six webinars ranging in topic from Particles in Biopharmaceuticals, to Environmental Monitoring Programs, to Biosimilar Development. See the complete list and links to the on-demand recordings below.
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.
Best Practices for Effective Environmental Monitoring Programs 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, clean rooms, production equipment, and water and gas utilities are free of viable and non-viable contamination and meet regulatory requirements.
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.
Biosimilars: Analytical and Clinical Development
The approval of the first biosimilar mAbs in Europe last June (Celltrion’s Remsima™ and Hospira’s Inflectra™ versions of infliximab) paves the way for the advent of more widespread access to biological treatments in indications such as rheumatology and oncology. One year on, lessons learned from these approvals will guide the global regulatory framework for such complex biomolecules.
Accelerating Vaccine Development: Regulatory, Biosafety, and Clinical Strategies
Health authorities and vaccine manufacturers worldwide are seeking efficacious, more cost-effective vaccines while expediting vaccines development to serve larger populations and meet potential pandemic threats. Additionally, vaccine developers must navigate a variety of regulatory, biosafety, and clinical development challenges to meet these demands.
Preparing for the New Elemental Impurities Guidelines
The bio/pharmaceutical industry has long anticipated revised guidelines for elemental impurities limits and testing. While many questions about the final guidelines, as defined in the International Conference on Harmonisation (ICH) in Q3D Guideline for Elemental Impurities and the United States Pharmacopeia (USP) in General Chapters <232> and <233> still remain, organizations should begin to initiate plans to transition to these new guidelines now.