• Karoline B. Bechtold-Peters Ph.D.
  • Linda Narhi Ph.D.
  • Diane M. Paskiet M.S.
  • Roman Mathaes Ph.D.

Proposal Description:

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Particles in parenteral products, especially in protein containing, is still a hot topic, even though it’s been discussed in many ways for many years. How do particles form? Are there reliable models for the generation of relevant species of protein particles? Which characterization tools make sense and where are the limitations? What standards are there or should there be? Subvisible versus submicron versus visible particles: which definitions should be used? This interactive workshop will have a lively discussion on these questions.

Learning Objectives

  • To understand different sources of particles/aggregates across the size continuum from oligomers through visible particles
  • There are analytical limitations on ability to characterize particles across sizes, and the need for relevant standards
  • Awareness of proper handling methods during clinical and commercial use of our drug products

Who Should Attend
Scientists involved in drug product/formulation development, analytical characterization, and drug product and drug substance manufacturing, both for innovator and biosimilar drugs; technical regulatory experts; suppliers of particle analytical equipment; regulators; academicians; pharmacists; and nurse practitioners.

Sub Sessions