Sponsors developing protein therapeutic products employ a variety of analytical methods to assess the quality attributes of their active ingredients and drug products for a number of purposes including characterization, lot release, and confirmation of stability.   Protein standards play a significant role in proper conduct of these analytical methods as well as drawing scientifically correct conclusions from the data obtained.  Different organizations create and utilize such standards in different ways, which are sometimes unique to individual organizations.   In view of increased interest in developing therapeutic biopharmaceuticals in recent years by organizations with experience and those new to the field, there would be value in capturing best practices for the creation, qualification, and maintenance of such standards.

This proposed conference will focus on these three broad topics, including identification of best practices in creating public protein therapeutic standards, and scientific discussion of the next step in an initiative to develop measurement standards for protein particulates.  Specific topics will include:

• Types of standards used for control of analytical methods
• Methods of preparation and qualification of analytical/biological potency standards
• Processes used to periodically requalify standards and/or assess the stability of standards
• Mechanisms  used to qualify a  subsequent standard when the supply of the first standard is exhausted
• When is there a need to replace a reference standard
• Balancing the use of primary standards versus assay controls, when and why
• Exploration of protein standard(s) needed to characterize subvisible particles for various analytical methods in terms of needs and attributes.
• Procedures for assessment of stability of potential protein standards
• Methods of standardization for potential subvisible protein particulate standard(s)
• How public standards play a role in the development and control of medicinal products

The goals of the meeting are to summarize currently available best practices and related information on the preparation and characterization of analytical standards for therapeutic protein products, to initiate dialogue on what types of measurement standards are needed for subvisible protein particulates, and also how analytical standards might be prepared, characterized, and standardized. An additional goal is to foster communication among academic, industry, and regulatory scientists on these topics. This meeting is co-sponsored by the US Food and Drug Administration (FDA), the National Institute of Standards and Technology (NIST), National institute for Allergy and Infectious Diseases (NIAID) and by the International Association for Biologicals (IABS), and is believed to be the first of its kind solely devoted to these topics of emerging importance.