Agenda Call for abstracts Speaker biographies Executive Summary
Overview
Continuous manufacturing (CM) is an exciting frontier in drug manufacturing with the capacity to increase process efficiency while reducing costs, potentially expanding availability and accessibility. The demand for CM is particularly relevant for biologics manufacturing, where production is costly, requiring robust and complex process control strategies to ensure product quality. Biopharmaceutical continuous manufacturing (BCM) has several potential advantages over batch manufacturing including:
- increased productivity
- enhanced process and product control
- increased flexibility
- decreased facility footprint and investment
- improved environmental impact
- reduced manufacturing costs
Implementing BCM requires a mindset shift including:
- converting stepwise unit operations into a continuous flow
- increasing reliance on real-time monitoring and control
- expanding data acquisition and management
- navigating regulatory uncertainty
- evaluating the business risk of doing something new
The United States Pharmacopeia (USP) and BioPhorum are pleased to co-sponsor a workshop that will explore the successes and challenges of developing and implementing BCM.
The workshop will consist of formal presentations followed by panel discussions that will provide opportunities for attendees to ask speakers questions and dig deeper into their presented content. The format for the workshop will be a hybrid model and include a blend of in-person and virtual participation.
Key topics
(See Call for Abstracts for additional details)
- Business case for developing and implementing BCM
- Technical challenges and successes for BCM
- Control strategies for BCM processes including process analytical technologies
- Regulatory considerations for implementing BCM
- Overcoming barriers/risks to bringing BCM to manufacturing
- Facility design or modification to facilitate adoption of BCM
- Impact of BCM on cost of goods
- Managing impact of BCM on time to clinic/market and ideas for acceleration
- Global needs vs. local needs, providing equitable access to Biologics via BCM
- BCM beyond mAbs; other advanced therapies
Types of presentations
- Case studies
- Success stories
- Sharing pitfalls/learnings
- Learnings from small molecule (process control, regulatory engagement, business case)
- New technologies
- Facility design/implementation
- Modeling
- Implementation strategies (mitigating risks)
Two presentation formats will be considered by the steering committee: full-length presentations (25 min) and short talks (5 min). The short talk format is meant to provide additional opportunities to connect with conference participants.
The Steering Committee
- Richard Chen, Executive Director, Purification Development and Viral Safety, Eli Lilly
- Chris Hwang, EVP and CTO, Transcenta
- Maura Kibbey, Principal Scientific Fellow, USP
- John F. Kokai-Kun, Director, External Scientific Collaboration-Global Biologics, USP
- Julie Kozaili, Senior Scientist, Asahi Kasei Bioprocess
- Graeme Moody, Facilitator, BioPhorum
- Kristina Pleitt, Sr Manager, Bioproduction R&D Innovation, Thermo Fisher Scientific
- Mark Schofield, Senior R&D Manager, Pall Biotech
- Andrew Zydney, Professor of Chemical Engineering, Pennsylvania State University
Who should participate?
- Scientists & engineers from industry and academia who are developing/implementing continuous manufacturing technology for biologics, or anyone interested in the subject
- Decision makers for manufacturing platforms
- QA/QC analysts interested in process analytic technology
- Quality and regulatory staff
- Contract research and manufacturing organizations
- Vendors developing novel technologies for BCM
- Data acquisition and analytics specialists
- Students and junior scientists
The Venue
The in-person participation will take place at USP’s Rockville, MD headquarters (conditions permitting). There will also be a virtual option for those who cannot attend in person.
Call for abstracts
Interested in submitting an abstract for the workshop? We want to hear from you! Submission deadline Aug. 1, 2022.
Get information about topics and submission instructions: Call for Abstracts