# Platform for reliable characterization and evaluation of comparability of biosimilar drug products in lyophilized and liquid formulations

> **NIH FDA U01** · NATIONAL INSTITUTE FOR PHARM TECH/EDUC · 2022 · $1,976,692

## Abstract

The standard for biosimilarity is the demonstration of analytical and functional similarity of a
biosimilar product to the reference product, with no clinically meaningful differences between the
two. Our objective is to develop a platform that allows for reliable characterization and evaluation
of comparability of biosimilar drug products. A key challenge when performing these activities is
that the excipients in the formulation interfere with the typical set of analytical and functional tools
that are otherwise routinely used for the characterization and comparability of drug substances.
As a result, biosimilar manufacturers resort to a variety of approaches to isolate the biotherapeutic
protein from the drug product formulation. However, this introduces an uncertainty brought about
by the impact of this isolation on protein stability and function. We will first identify the root of
challenges that impact the characterization of biotherapeutic drug products. Armed with this
understanding, this project aims at creating an analytical platform that allows us to perform reliable
analytical and functional characterization and evaluation of the comparability of biosimilar drug
products. Comprehensive characterization of excipients, alone and in compositions simulating
biosimilar products will be carried out. In addition, analytical and functional characterization of
biosimilars and the reference product will be conducted. Finally, the container-closure systems
will be evaluated.

## Key facts

- **NIH application ID:** 10619335
- **Project number:** 1U01FD007758-01
- **Recipient organization:** NATIONAL INSTITUTE FOR PHARM TECH/EDUC
- **Principal Investigator:** Raj Suryanarayanan
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2022
- **Award amount:** $1,976,692
- **Award type:** 1
- **Project period:** 2022-09-01 → 2025-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10619335

## Citation

> US National Institutes of Health, RePORTER application 10619335, Platform for reliable characterization and evaluation of comparability of biosimilar drug products in lyophilized and liquid formulations (1U01FD007758-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10619335. Licensed CC0.

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