Pre-Conference Workshops | Tuesday, January 31

WORKSHOP A

Empty-Full Separation: Downstream’s Stumbling Block
9am – 11am

Similar physiochemical properties between empty and full capsids complicate their separation and hinders adeno-associated virus (AAV) product consistency. There is a pressing need for setting regulated threshholds for empty/full separation and creating a platform separation technology that is robust and suitable for a variety of AAVs. By the end of this workshop, you will be able to discuss:

  • The impact of the empty capsids in AAV products in terms of purity
  • Are empty capsids process-related impurities? Or do they have a biological function during treatment?
  • The proposed draft guidance to the FDA on testing for empty capsids during product manufacture

Workshop Leader

xiaolong

Xiaolong Lu
Director, Downstream Process Development, Gene Therapy Program
University of Pennsylvania

Kenneth Yancey]

Kenneth Yancy
Senior Director, Downstream Vector Operations
University of Pennsylvania

Haiyan Liu

Haiyan Liu
Executive Director of Analytical Science &
Technology
University of Pennsylvania

WORKSHOP B

Transfection Scaling Challenges for Viral Vector Manufacturing
12pm – 2pm

At lab scale, transfecting cells with multiple plasmids is manageable with respect to material volumes & transfer times. However, scaling for viral vector transient production based on adenovirus (AV), adeno-associated virus (AAV) and lentivirus (LV) can be complex. This workshop will address the following:

  • Optimising the volumes of cell-culture media and transfection reagents
  • Perfecting your scale-down model to clarify the conditions that will impact your process at large-scale
  • Determining the impact of upstream processes on product quality

Workshop Leaders

Itzcoatl Pla

Itzcoatl Pla
Head of Gene Delivery, Process and Analytical Development,
Bristol Myers Squibb

julia rohlhill

Julia Rohlhill
Scientist, Viral Vector Process Development
Bristol Myers Squibb

patrick

Patrick Westmoreland
Principal Scientist, Viral Vector & Gene Editing Process Development
Bristol Myers Squibb

WORKSHOP C

Keeping Quality: Defining CQAs for New Viral Vectors
3pm – 5pm

Pushing life-saving cell & gene therapeutics into market requires accurate testing of Critical Quality Attributes (CQAs), including accurate viral vector analysis. However, with a handful of these novel therapies approved, defining CQAs for distinct vectors can pose to be a rate-determining bottleneck. In an interactive and discursive approach, this workshop will help you answer the following questions:

  • How can you generate CQAs that are bespoke to your vector of interest while taking into consideration the differing size & complexity of viruses?
  • How can you find quality attributes that can specifically relate to vector potency?
  • What are some novel quality attributes plugging the gap in commonly used CQAs?

Workshop Leaders:

Qingwei Deng

Qingwei Deng
Associate Director, Analytical Development Lead
UCB

stephen

Stephen Zano
Associate Director, Early Research & Process Development
Sarepta Therapeutics

FULL EVENT GUIDE
SPEAKERS
DAY ONE