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title: A New Approach to Supporting Quality of Biologics
description: In this webcast, learn how USP’s emerging standards for biologics can support efficient development and regulatory review and more.
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# A New Approach to Supporting Quality of Biologics

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## Presenter:

****![07-16-2026-USP-HS-Cropped](https://bpi.bioprocessintl.com/hs-fs/hubfs/07-16-2026-USP-HS-Cropped.jpg?width=160&height=231&name=07-16-2026-USP-HS-Cropped.jpg)****

**Diane McCarthy, PhD**

*Vice President, Global Biologics,*

United States Pharmacopeia (USP) 

[LinkedIn](https://www.linkedin.com/in/dianebmccarthy)

 

Diane McCarthy, PhD is vice president, global biologics at USP, where she leads the development of science-based standards and tools to address critical challenges across the biotechnology industry and ensure the quality of biologic medicines. Dr. McCarthy has guided programs spanning a broad and rapidly evolving portfolio of therapeutic modalities, including monoclonal antibodies, cell and gene therapies, vaccines, and peptides. In her role, she oversees the development and lifecycle management of documentary and physical reference standards, as well as other tools that support biologics quality across the product lifecycle.

## About this event:

#### Date: July 16, 2026

#### Time: 11 am EDT | 8 am PDT | 5 pm CEST

#### Duration: 60 minutes

| Biological therapies are transforming modern medicine, enabling new treatments for cancer, autoimmune, inflammatory, and other diseases. However, many patients around the world do not have access to these medicines. Biological medicines are complex to manufacture and test, requiring multiple analytical tests for assessment of different quality attributes. A lack of common expectations across the globe on appropriate methods and analytical performance can create inefficiency and inconsistency both in product testing and in interpretation of resulting data. At the same time, a significant “biosimilars void” is emerging—118 biologics are expected to lose patent protection in the coming decade, while only 12 have biosimilars in development—highlighting an urgent need for new approaches to expand patient access. To address this challenge, the US Pharmacopeia (USP) is leveraging its emerging standards platform. USP posts early concepts for potential standards on this platform, which creates a new collaborative pathway where stakeholders can help shape potential future standards. This webcast will provide an overview of the platform and its latest expansion to include emerging standards for select biologics, including newly released product-specific analytical methods for molecules such as Bevacizumab, Epoetin, Interferon beta 1-a, and Rituximab. These biologics emerging standards emphasize product quality attributes, system suitability, and assay performance, while allowing flexibility in analytical approaches and leaving product specification-setting to regulators. Diane McCarthy, PhD, vice president of biologics at USP, will outline the structure of biologics emerging standards and how the components support development workflows. She will clarify appropriate use for these emerging standards, emphasizing their role as flexible tools, and explain how stakeholders can submit feedback on the concept and contribute alternative methods. Join this webcast to learn how USP’s emerging standards for biologics can help support more efficient development and regulatory review, enable regulatory convergence across regions, and help reduce duplication for manufacturers, with the goal of ultimately supporting expanded availability of biological medicines for patients. |
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