Events are FREE to qualified industry participants and decision-makers.
October 27, 2022, 11am-1pm ET, Virtual
The goal is to make more products faster and more efficiently, without sacrificing quality. Before implementing change, you need to answer several core questions, including: How can I intensify an established process with minimal risk? Why should I change a working, validated process? What are the appropriate technology options and what metrics should be considered to justify their investment?
Our speakers provide insight on their experiences, decision-making processes and outcomes.
Meeting Agenda (subject to change)
Moderator: John Bonham-Carter, Vice President Business Development and Product Management, Erbi Biosystems
11:00 am – 11:30 am Meet and Greet Networking + Welcome
11:30 am – 11:50 am Case Study 1: Changing Technologies Within an Established Manufacturing Process (Arthi Narayanan, Innovation Team Leader, Pharma Technical Operations, Genentech)
* How to upgrade technologies within existing process
* What’s the justification – Why bother
* How good does the improvement have to be to justify investment
* Factoring in regulatory considerations
* Satisfying internal and FDA regulatory concerns
11:50 am – 12:10 pm Case Study 2: Justifying the Process Change
* Why change a working process
* What’s the incentive/motivation
* How to justify the investment
* Critical data needed to support your decision
* Managing expectations
12:10 pm – 12:30 pm Case Study 3: Leveraging Established Processes - Intensifying with Minimal Risk
* How to decide on intensification for one product vs. continuous for another
* What factors must be considered to make the best decision
* Leveraging data/knowledge from sites using different techniques. Assessing performance.
* What metrics should you use to determine/decide * Lessons learned
12:30 pm – Close Deep Dive Networking
What to expect as an Evaluating Biopharma attendee:
* Unique access to our speakers' thought process, experience, insight
* Roadmap to making better bioprocessing technology and operational decisions
* Interactive forum to meet, interact and learn from industry peers