The AAPS Journal publishes reports from two recent AAPS workshops that covered a draft guidance on immunogenicity and a draft guidance on the use of nanomaterials.
In September 2018, AAPS held the first AAPS Guidance Forum. To determine the topics covered by this two-day workshop, AAPS members completed a survey showing which guidances impact their work the most. The results informed the decision to highlight the following two draft guidances: Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products, released in April 2016, and Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry, released in December 2017.
Immunogenicity
The AAPS Journal published Report on the AAPS Immunogenicity Guidance Forum covering the AAPS Guidance Forum on the FDA draft guidance Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products in 2018. The event was well-attended by leading scientists from the Food and Drug Administration (FDA) and the pharmaceutical industry.
This article provides both the regulatory and industry perspectives on best practices related to the guidance, and it summarizes discussions on cut points and clinical trials, multiple labs, and rare diseases. Although the industry and regulatory representatives agreed on most topics, there are a some recommended assay attributes that are still debated, such as the rationale for producing extremely sensitive antidrug antibody (ADA) assays, the process of determining low-screen cut-point values, the relevance of pre-existing antibodies, and the clinical relevance of ADAs detected in these highly sensitive assays.
This AAPS workshop continues the trend of an open and transparent dialogue between regulatory and industry colleagues, allowing further understanding of the important topic of immunogenicity monitoring for biotherapeutics.
Find the full article in The AAPS Journal to learn more about this important conversation and the next points of discussion that need to be resolved.
Since the 2018 AAPS Guidance Forum, FDA released the finalized guidance Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection.
Nanomaterials 
This AAPS Journal article summarizes the lively debate between scientists from industry, academia, and regulatory authorities at the AAPS Guidance Forum on the FDA draft guidance Drug Products, including Biological Products, that Contain Nanomaterials, held in September 2018. Discussions at this workshop addressed two questions that were determined by a survey sent to AAPS members in spring 2018:
- What is the appropriate regulatory pathway for approval of drug products containing nanomaterials?
- How should critical quality attributes for nanomaterials be determined?
During the meeting, clarification was provided on how the new guidance relates to older, specific nanomaterial class or specific product-related guidances. Speakers from the Food and Drug Administration invited participants to share their questions about this draft guidance to avoid any doubt on how to read and interpret guidances for the development of new drug applications and abbreviated new drug applications. Participants agreed that aligning the release of guidance documents with a public discussions such as this AAPS Guidance Forum is mutually beneficial to both regulators and industry stakeholders.
Find the full article in The AAPS Journal to read a summary of the workshop discussion and to learn the group’s observations and recommendations.
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