Innovative analytical and digital solutions to advance biomanufacturing and product quality
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Registration Agenda Speaker Biographies
Join industry, regulatory, and scientific experts at the next annual meeting of the USP Biologics Stakeholder Forum. Exploring industry's most pressing challenges at the interface of biotherapeutic quality and innovation, each meeting of this Forum series will focus on a single area of biotherapeutic quality that could be advanced through collaborations with USP – an independent scientific organization that develops quality standards used globally by industry.
This second Forum presents an opportunity to engage with industry leaders, regulators, and USP to help shape the development of quality standards to support in-process analysis of biologics that enables near or real-time decision making during biomanufacturing, where manufacturing processes can be complex, requiring appropriate control strategies to ensure the quality of the product. Although innovation in this area is often associated with manufacturing of recombinant proteins where decades of manufacturing knowledge has identified critical process parameters that impact product quality attributes, it can be even more important in personalized medicine where reduction of risk to small batch sizes is critical, and any issue in the manufacturing process must be identified as soon as possible.
The Forum will allow attendees to:
- Hear about innovative analytical technologies that allow real-time monitoring of biologics during manufacturing
- Discuss challenges around implementing new test methodologies and approaches in a GMP environment
- Identify standards that might support these innovative approaches supporting quality and efficient testing
Virtual Format:
Each day will begin with presentations by subject matter experts developing or implementing these new technologies for biomanufacturing. They will share the benefits to better decision-making earlier in production while also sharing challenges to implementation of novel technologies and associated software. Following those presentations, attendees will be divided up into small groups to discuss what they heard and share their own experiences and challenges. At the end, groups will report back their findings to the larger group and share recommendations that USP should consider to help advance the adoption of these new technologies.
Contact Information
Jacqueline Starkes
Stakeholder Operations
Phone: 301-230-6358
Mobile: 202-288-0251
12601 Twinbrook Parkway
Rockville, MD 20852