The biopharma industry is increasingly embracing the concept of ‘Acceleration Levers’ to optimize timelines and expedite time to market, as late-phase chemistry, manufacturing and controls (CMC) programs often face delays that jeopardize speed to market and strain development resources. This webinar explores strategies for reducing late-phase CMC timelines for mammalian and microbial-derived therapeutic proteins.
The featured speaker will explore the definition of an acceleration lever and examine how its application can vary based on differing risk profiles and perspectives. The speaker will also discuss key strategic levers that can drive acceleration, highlighting their potential impact on timelines and success in therapeutic protein development.
Register for this webinar to learn how to apply acceleration levers in late phase CMC to reduce timelines and improve program efficiency.
Speaker
Ian Brown, PhD, Senior Director Process Characterization and Process Validation Sciences, FUJIFILM Biotechnologies
Ian Brown, PhD, holds the position of Senior Director of Process Characterization and Process Validation Sciences and has the responsibility of guiding partners through the late phase CMC journey within FUJIFILM Biotechnologies. Ian has 20 years of experience in bioprocessing and has held various roles within the organization, leading microbial and mammalian process development programs. Ian holds a PhD from the University of Sunderland in Biochemistry and Molecular Biology.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Process Development Scientists
- Quality Assurance Manager
- Regulatory Affairs Specialist
- Manufacturing Manager
- Analytical Development Scientist
- Validation Engineer
- Operations Director
- Consultants
- Anyone with CMC in their title
What You Will Learn
Attendees will gain insights into:
- Understanding Acceleration Levers: what acceleration levers are and how they are utilized to optimize timelines and expedite the market readiness of therapeutic proteins
- Strategies for CMC Timelines: strategies specifically focused on shortening the late-phase CMC timelines for both mammalian and microbial-derived therapeutic proteins
- Risk and Impact Analysis: the varying applications of acceleration levers based on risk profiles and perspectives, as well as their potential impact on the development timelines and success rates
Xtalks Partner
FUJIFILM Biotechnologies
FUJIFILM Biotechnologies, a subsidiary of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization (CDMO) for biologics, vaccines and advanced therapies. With over 30 years of experience, the Company specializes in developing and manufacturing biopharmaceuticals using microbial, mammalian, and host/virus systems. With over 4,800 employees, FUJIFILM Biotechnologies operates a fully integrated, kojoX™ global network with major facilities in the United States, the United Kingdom, and Denmark, with a new site in Holly Springs, North Carolina, USA. The Company’s kojoX™ manufacturing network ensures supply chain agility for its customers through modular facilities and standardized processes for seamless scaling and technology transfers. FUJIFILM Biotechnologies offers comprehensive services, ranging from proprietary cell line development, to process and analytical development, and through to clinical and commercial manufacturing.
You Must Login To Register for this Free Webinar
Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.
Create Account