Control and Determination of Visible and Sub-visible Particulate Matter in Biologics

June 26, 2017 - June 27, 2017

Regulations direct drug product manufacturers to exclude foreign matter and minimize foreign particle content. Particles can originate from the environment, packaging materials, formulation ingredients, interactions between product and packaging, or be inherent to the product. For inherent species, or the expected formulation-related particle species, which techniques may be most appropriate? This workshop will be a forum for discussing the control and determination of undesired visible and sub-visible particulate matter and also characterization of inherent particle species in biopharmaceuticals.

Agenda Register

Why Attend?

  • Gain insight into the USP standard process and how to work with USP to impact future standards.
  • Obtain feedback about the current chapters and where gaps exist for future standard work.
  • Identify areas where USP can broaden our scope in the biologics space.

Who Should Participate?

  • Analytical chemists and biologists
  • QA/QC analysts
  • R&D scientists, managers
  • Manufacturing scientists, managers
  • Regulatory affairs specialists
  • Contract research organizations
  • Contract manufacturing organizations

Workshop Steering Committee

  • Scott Aldrich, Ultramikro, LLC
  • Mohammad Heidaran, U.S. Food & Drug Administration
  • Ewa Marszal, U.S. Food & Drug Administration
  • Anthony Mire-Sluis, AstraZeneca
  • John Shabushnig, Insight Pharma Consulting LLC
  • Darin Weber, Medeor Therapeutics
  • Wesley Workman, Pfizer
  • Earl Zablackis, Sanofi Pasteur
  • Kevin Carrick, USP
  • Desmond Hunt, USP
  • Maura Kibbey, USP

Registration Information

12601 Twinbrook Parkway
Rockville, MD 20852
United States
Phone: +1-301-816-8136
See map: Google Maps

Call for Abstracts

Interested in submitting an abstract for the workshop? We want to hear from you! Click here for topics and submission instructions.

Please note that registering for a USP event requires an Access Point account. Please follow the instructions after clicking the “Register” button. Registration is payable by credit card only. Registration fee includes the full two-day program, meeting materials, coffee breaks, and a lunch and a networking reception.

Registration fees for this workshop have been set as follows:

Participant Type

Regular Fee Per Person
(1-2 individuals from the same organization)

Multi-Registrant Price
(3 or more individuals from the same organization; all must register at the same time to receive the discount)

Academia /Association Participant



Government Participant


Not Available

Industry Participant



Student (Full-time; valid I.D. required)


Not Available

WebEx/Virtual Participant


Not Available

Advance Registration Deadline

Advance registration will be available through June 21, 2017 After that date, registration will be available on site at the USP Meetings Center.

Registering Others

When registering colleagues (not yourself), please create your own Access Point account and then check the “I am registering others – not myself” box at the top of the registration form. If you are registering multiple people, please select “add additional registrants” on the final page of the registration form (before submitting payment).

Cancellation and Substitution Policy

Cancellation must be received on or before June 5, 2017 via email to Refunds will not be issued for cancellations received after this date. There is a $50.00 processing fee on all cancellations; however, it is permissible to send a substitute registrant from your same organization. Substitutions must be submitted in writing via email to

Invitation Letters for Visas

USP cannot provide an invitation letter to potential workshop attendees; however, once you are registered, USP will provide a registration confirmation that may be utilized to obtain a visa.

Registration Questions

Please contact or +1 301-816-8130.

Local Area Information

Visit our Travel & Transportation page for information on lodging, airports, and local transportation in and around USP’s Rockville, Maryland, campus.