DC Discussion Group
With the origins of CASSS in mind, the DC Area Scientific Discussion Group offers an opportunity for CASSS members to meet others who understand what they do in an informal setting and exchange new ideas. They have been bringing people in the field of biotechnology and biopharmaceutical development together since 2014. This group’s mission is "Bringing Together Industrial Challenges in the Development of Biologics with Advances in Science and Technology." Anyone in the greater DC/Maryland area (or for virtual meetings, anyone around the world) affiliated with biotechnology, or interested in learning more about the scientific and technological applications to biotechnology is invited to attend.
Click on the sections below for detailed information:
Potency Assay for Complex Biologics (Including Cell and Gene Therapies) – How to Make it Robust and Precise | October 14 15:00 - 17:00 EDT | Rockville, MD
This DCDG will focus on sharing best practices on how to improve potency assay robustness and precision through a panel discussion and networking opportunities. Register for in-person attendance by October 10.
Location:
Institute for Bioscience and Biotechnology Research
9600 Gudelsky Dr.
Rockville, MD, USA 20850
Attendance and Substitution Policy
CASSS reserves the right to withdraw, replace, add, or substitute presenters, speakers, and other guests without notice. Entry into the conference is at the sole discretion of CASSS and CASSS reserves the right to refuse entry to anyone for any reason.
Potency Assay for Complex Biologics (Including Cell and Gene Therapies) – How to Make it Robust and Precise | October 14 15:00 - 17:00 EDT | Rockville, MD
The criticality of potency assay in complex biologic therapeutic development is widely recognized. However, its implementation in a GMP QC lab remains a challenging task for the industry. A typical potency assay involves many complicated steps and needs multiple days to finish. Many potency assays are cell-based, which adds additional labor-intensive steps and long preparation time. High assay variability is commonly seen and contributes to costly out of specification/trend investigation and even lot rejection. Cell culture practice/passage, pipetting, mixing techniques, crucial reagent and equipment have all been shown to impact assay precision.
This DCDG will focus on sharing best practices on how to improve potency assay robustness and precision. Much of our experience and knowledge gained during therapeutic protein (e.g. mAbs) development could be leveraged in addition to some unique aspects for complex biologic products.
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If you have any questions about this media kit, please reach out to Renee Olson.
