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.

HJB's Chief Technology Officer Dr. Chris Hwang was invited to attend and make a speech.

Date: 7 December (Wednesday)

Time: 1:45 - 2:05

【Keynote】

Development and Industrialization of Highly Intensified Connected/Continuous Biomanufacturing Platform (HiCB) to Address Patient and Business Needs