Pre-Conference Workshops | Tuesday, June 20


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:

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Michelle Hernandez
Director Occupational Toxicology
Merck & Co.

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Rich Arnett
Manager Industrial Hygiene & Toxicology


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

• Evaluating the cost/benefit of investment

Workshop Leaders:

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Onkar Manjrekar
Principal Research Scientist I

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Srinath Thirumalairajan
Director Process Development


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

• Visualizing how small-scale automation can enable rapid scale up to
accelerate the route to market

Workshop Leader

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Roee Ramot
Senior Scientist II