Modern DoE, Quality by Design and the Chemistry, Manufacturing and Control (CMC) Pathway – How they all come together

The path to commercialization of a pharmaceutical or biopharmaceutical product is complex and often lengthy. There are a number of milestones that must be fulfilled to ensure compliance, but this also facilitates a well-developed molecule and process.

This hands-on workshop will use the framework of the CMC pathway to guide the introduction of important statistical concepts such as: Modern DoE; predictive modeling using a new approach for small data known as self-validating ensemble modeling (SVEM); and risk assessments. The goal is to maximize process development earlier rather than later and leverage early learnings more effectively throughout the entire CMC pathway. Often the data sets are small especially with regards to scale-up data and having statistical tools that are designed for small data sets is key as well as understanding the limitations of current data analysis tools will be explored; students will be introduced to SVEM and shown how to apply it to small data. We will take an example, such as a plasmid DNA fermentation and highlight activities in the CMC Development Pathway and how they can be re-energized by using modern machine learning and DoE methods optimized for small data sets and implemented through the JMP™ statistical software; many of the DoE and statistical methods covered are unique to JMPTM.

Participants will gain insight on the newest Modern Design methods and greater familiarity with the CMC pathway whether you are in early development of about to commercialize. Participants will also become familiar with the concepts of Modern Design of Experiments, Machine Leaning methods and how they facilitate greater understanding -for instance in process development.

Saturday, November 6, 2021

8:30am – 4:30pm

Location

Hyatt Regency Coconut Point

Workshop Fees

Early/Regular Registration

SIMB Member: $600
Nonmember: $750
Student: $225

Onsite Registration

SIMB Member: $700
Nonmember: $850
Student: $225

Organizers

Tiffany Rau
Rau Biotech

Phil Ramsey
U New Hampshire

Limit: 30 attendees