Mi Jin

Company: Spark Therapeutics

Job title: Senior Director, Head of Downstream & Drug Product Development

Bio:

Sr. Director of Downstream and Drug Product Development at Spark Therapeutics, with over 20 years’ experience in protein characterization, biologics and gene therapy manufacturing process development, scale up, tech transfer, process characterization/PPQ and regulatory filing.  

Seminars:

IMPROVING YIELDS & QUALITY IN VIRAL VECTOR MANUFACTURING 1:00 pm

Choosing an upstream production format (transient transfection, infection, packaging and producer cell line etc); impact on speed to clinic and quality of viral vector Optimizing purification methods to maximize both recovery and quality; levers to pull and how to reach them Innovation in analytical technologies; building process and product understanding while minimizing the “QC Tax”…Read more

day: Worksho Day - Track a PM

Panel Discussion: Establishing a Commercial-Ready CMC Checklist for Expedited Pathways 2:15 pm

Defining key sticking points to ensuring CMC and clinical development are aligned when a programme is under an expedited pathway Considerations for CMC-focused meetings with the regulators when moving through the clinic Laying out a commercial manufacturing plan upon receiving an expedited pathway designationRead more

day: Day 2 MANUFACTURING PM

Evolution of Downstream Manufacturing Process Design for Productivity, Product Quality and Process Consistency 11:30 am

Moving towards scalable and commercial manufacturing – ready purification processes Process design for increased productivity, high product quality, and reduced manufacturing cost Speed to clinic considerations Process characterization and control strategy definition to enable robust critical quality attributes (CQAs) control for commercializationRead more

day: Manufacturing - AM