Pre-Conference Workshops | Tuesday, June 20
WORKSHOP A
Examining the Viability of Process-Specific Analysis Replacing Control Banding to Avoid Over Engineering & Maximize Cost-Effectiveness
8:30am – 10:30am
Control banding has long been a critical element of process development for highly potent drugs. However, as potency increases and containment requirements increase, could a process-specific approach drive costs down and improve process safety?
This hands-on session will help you:
• Uncovering how the current banding structure can lead to overengineering
• Assessing process-specific methods to determine the API’s hazard level
• Evaluating how to remain harmonized with CDMOs
Workshop Leaders:
Michelle Hernandez
Director Occupational Toxicology
Merck & Co.
Rich Arnett
Manager Industrial Hygiene & Toxicology
Pharmascience
WORKSHOP B
Evaluating the Feasibility of Continuous Manufacturing as a Resolution for Highly Potent Containment Challenges to Improve Safety
11:00am – 1:00pm
With continuous manufacturing becoming the “holy grail” for drug manufacturing, its potential as a solution for highly potent containment challenges is being explored. However, technical and financial challenges remain about a fully integrated manufacturing process for highly potent drugs.
This hands-on session will help you:
• Examining key considerations to determine whether a process can be
adapted to be continuous
• Determining how continuous manufacturing could offset containment
challenges
• Evaluating the cost/benefit of investment
Workshop Leaders:
Onkar Manjrekar
Principal Research Scientist I
AbbVie
Srinath Thirumalairajan
Director Process Development
Seagen
WORKSHOP C
Advancing Bench-Scale Automation of Highly Potent Manufacturing for Scientist Safety, Process Efficiency & Facile Scale-Up
2:00pm – 4:00pm
Process automation for bench-scale highly potent manufacturing is a promising solution for scientist safety. However, it is challenging to understand what are the steps that can be automated.
This hands-on session will help you:
• Discussing different bench-scale automation techniques
• Outlining the process steps that are technically and financially viable to
automate
• Visualizing how small-scale automation can enable rapid scale up to
accelerate the route to market
Workshop Leader
Roee Ramot
Senior Scientist II
Novartis