Meeting Regulatory Requirements for Cell and Gene Therapy Manufacturing

[Available On-Demand]
Search General Info
Search Education
Search Partnering Companies
Lonza is a global leader and well known contract development and manufacturing organization in the field of life sciences. Lonza was founded in 1897 and has more than 50 manufacturing sites wordwide in more than 30 countries employing close to 15,000 employees. Lonza’s mission is to industrialize manufacturing from concept to patient and therefore provides cutting edge solutions during development and manufacturing. Lonza’s vision for cell and gene therapy is to deliver the medicines of tomorrow, today. Lonza’s cell and gene technologies business unit is expanding its global foot print and increasing its manufacturing capacity through innovating in key areas such as process and analytical development and manufacturing. This webinar is intended to provide the audience with an understanding on the following topics;
• Existing regulatory landscape, guidance and regulations applicable to cell and gene therapy products
• Hot topics related to manufacturing facilities to be considered during regulatory filings
• Segregation measures and controls pivotal for a multiproduct facility
• Lonza’s regualtory capability and offering such as master files that sponsor’s can utilize to accelerate their regulatory timeline

Speaker - Karen Magers, Head of Regualtory Affairs, Cell and Gene Technologies
Rajesh Thangapazham, Head of Regualtory Strategy, Cell and Gene Technologies, Lonza Pharma and Biotech
Sponsored By