Fran DeGrazio

Vice President, Scientific Affairs & Technical Services

July 18, 2017

USP Particle Workshop – Addressing Issues and Improving Clarity

United States Pharmacopeia (USP) held a two-day workshop, Control and Determination of Visible and Sub-Visible Particulate Matter in Biologics, June 26 & 27 at their Rockville (MD) site. This was the first USP particle workshop in several years; the robust attendance demonstrated that control of particles continues to be a major focus of the pharmaceutical industry.

Fran DeGrazio 

 

A range of topics were covered:

Day-1

  •  Inherent particle challenges with biologic drugs and cell therapy products
  • Safety impact of particles
  • Regulatory perspectives
  • Testing perspectives for biologic drugs

Day-2

  •  Mitigation of particles during manufacturing
  • Control measures for packaging components
  • Particle formation during fill/finish
  • Risk-based approaches to visible particle inspection

Key take-aways were noted:

  • USP is planning to create a Chapter specific to a standard for particles in packaging components and administration systems.
  • NIST has completed the next generation of standards for protein particle testing (based upon abraded ETFE) – scheduled to be available in Fall-2017.
  • Upstream controls are extremely important – explaining why there is such a focus on mitigating particles on packaging components and other upstream processes that lead to the completed filled biologic drug (which is visually inspected at 100%).
  • Silicone oil use continues to be an area requiring better understanding, investigation, and control.
  • In respect to the biologic drug itself, 2-10 micron particles are important to understand, however the technology is still not strong in being able to accurately quantify particles at this size.

The issue of particles is challenging; clearly needed is a cross-industry approach, comprising industry, academia, regulators, and suppliers, to consider life-cycle management and improve clarity. West remains at the forefront of particle technology – active in organizations addressing them, and developing new methods to measure them – always with the focus of patient safety. To read more on particle technology visit West's Knowledge Center on our website.