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:
Attend

Visible Particles | June 4 15:00 EDT | Rockville, MD

Join us in person on June 4 at the DC Discussion Group for a discussion on visible particles. Network with DC-area CASSS members. Registration for this free opportunity closes June 2.

Location:
IBBR (University of Maryland - Institute for Bioscience and Biotechnology Research)
9600 Gudelsky Dr
Rockville, MD 20850

Register for DC Discussion Group

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.

Abstract | June 4
Visible particles in current biopharmaceutical products remain a cross cutting challenge, often perceived as a failure of inspection rather than a lifecycle quality issue. In practice, manufacturers are advancing science- and risk-based strategies, but progress is slowed by internal constraints, the need for a mindset shift from zero tolerance to risk proportionate control, and the difficulty of embedding particulate control into quality systems. Differentiating intrinsic proteinaceous particles from extrinsic contamination and inherent formulation phenomena (e.g., opalescence, silicone oil droplets) is particularly complex, with inconsistent recognition of clinical relevance and resource intensive, cross functional investigation. This session convenes industry and agency perspectives to share practical, credible approaches to managing visible particles across formulation, container–closure, aseptic processing, and inspection. Discussion will focus on building end to end control strategies that align with pharmacopeial expectations (e.g., “essentially free”), tuning automated and human visual inspection for specificity without untenable false rejects, and leveraging orthogonal analytics and prior knowledge - especially for platforms such as monoclonal antibodies in vials and prefilled syringes. Attendees will gain actionable tactics for defining defensible acceptance criteria, accelerating root cause triage, and implementing sustainable mitigations (e.g., silicone management, component cleanliness, cleanroom behaviors) that reduce complaints and field action risk while protecting supply continuity. 
Panelist | June 4
DC Discussion Group Featured Panelist Srivalli N. Telikepalli, NIST

Srivalli N. Telikepalli
National Institute of Standards and Technology (NIST)

Srivalli Telikepalli, Ph.D., Research Chemist, Biomolecular Measurement, National Institute of Standards and Technology. Telikepalli received her B.A. in chemistry at Cornell University in 2008 and her Ph.D. in Pharmaceutical Chemistry from the University of Kansas in 2014. Her thesis work was focused on understanding the formation of protein aggregates/ particles as a function of different stresses and understanding the relationship between protein particle properties and their in-vitro immune responses. Upon completion of graduate school, she started working as a Research Chemist at the National Institute of Standards and Technology in the Biomolecular Measurements Division. Currently, her work focuses on developing protein-like particle standards, primarily subvisible and visible particle standards, as well as lending support to developing monoclonal antibody reference material.

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If you have any questions about this media kit, please reach out to Renee Olson.

Register Now

Save your spot for the DC Discussion Group on June 4, 2026. Registration for this free opportunity closes June 2, 2026.

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