Course Description:This webinar introduces a new USP General Chapter that provides guidance and considerations specific to biotechnology product stability with a focus to streamline development programs and achieve sustainable commercial product expiries. Stability of biologics often proves rate-limiting towards product development and market registration. Biotechnology or biological medicinal products are inherently complex, often requiring specialized technologies and procedures to ensure their quality, safety and efficacy. One of the essential requirements for any medicinal product is that product stability is maintained throughout the product shelf life. In addition, the stability of the product must be assured from the moment it leaves the company until it is administered to the patient.
Includes English subtitles
Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Upon completion of this course, you will be able to:
- Understand the regulatory requirements and expectations related to biotechnology product stability programs
- Recognize how to design stability strategies from pre-clinical to commercial lifecycle management
- Explain example designs for biotechnology product stability testing
Who should participate:
- Lab managers, principal scientists, R&D, analytical, QA/QC scientists at biopharmaceutical companies
- Scientists at CDMO’s and contract analytical labs
- Regulatory experts working in the field of biologics