Nuvalore to Showcase Innovative DoE-Based Analytical Method Development at Festival of Biologics 2025

Leimen, Germany – nuvalore GmbH, a trusted provider of GMP- and ICH-compliant contract laboratory services for the pharmaceutical and life sciences sector, will  exhibit at Festival of Biologics 2025, Booth S6, showcasing its expertise in advanced analytical method development and validation. nuvalore Founder and Managing Director, Dr. Anamarija Ćurić  will also present a poster  on innovative approaches to biopharmaceutical quality control.

Scientific Poster Presentation

The poster will showcase nuvalore’s research on “Design of Experiments (DoE) for Method Optimization: A Case Study on imaged Capillary Isoelectric Focusing (icIEF) for Charge Variant Analysis in Biopharmaceuticals”, highlighting how nuvalore applies Quality by Design (QbD) principles combined with Design of Experiments (DoE) methodology to optimize analytical methods for biologic medicines.

Using infliximab as a model antibody, nuvalore researchers systematically evaluated multiple critical parameters, including ampholyte concentration, spacer concentration, denaturant type, and ampholyte brand. The study demonstrates how structured experimental design can significantly improve method robustness, reproducibility, and efficiency, supporting more reliable charge variant analysis.

“Charge heterogeneity is one of the most critical quality attributes of monoclonal antibodies, directly impacting product safety and efficacy,” said Dr. Anamarija Ćurić, Founder and Managing Director of nuvalore. “Our work demonstrates that a science-driven DoE approach within a QbD framework enables more efficient method development while ensuring regulatory compliance and data reliability.”

Industry Impact and Innovation

This research builds upon nuvalore’s continued commitment to advancing pharmaceutical analytics through scientific innovation. Following the company’s successful presentation at POWTECH, where nuvalore presented advanced pharmaceutical analytics solutions, the Festival of Biologics presentation further demonstrates the company’s dedication to supporting the pharmaceutical industry with cutting-edge analytical approaches.

The icIEF method optimization research represents nuvalore’s platform approach to analytical method development, designed to be transferable across multiple biologics projects. This methodology not only optimizes individual methods but also creates a foundation for future-proof analytical solutions that can accelerate drug development timelines while maintaining the highest quality standards.

nuvalore’s DoE-based approach addresses critical challenges in biopharmaceutical development by transforming traditionally time-intensive method development into a data-driven, efficient process. nuvalore’s DoE based  methodology provides clear linkage between critical parameters and quality outcomes, supporting risk-based regulatory decision making while reducing development timelines and resource requirements.

“Our goal is not only to optimize individual methods, but to establish a platform that raises the overall standard of analytical development,” said Dr. Ćurić. “By integrating Quality by Design with Design of Experiments, we’re helping the industry move toward more robust, future-proof solutions that ultimately bring biologic medicines to patients faster and with greater confidence.”

Special Offer for New Customers

Festival of Biologics attendees are invited to visit nuvalore at booth S6 to learn about the company’s analytical services and discover how new customers can receive 20% off services.

About Nuvalore

nuvalore GmbH is a contract quality control laboratory based in Leimen, Germany, specializing in the analytical characterization of pharmaceuticals and biopharmaceuticals. Founded in 2024, the company has quickly established a reputation for excellence in analytical method development, validation, quality assurance, and consultancy services for the pharmaceutical and life sciences industries.

nuvalore’s portfolio includes Analytical Quality by Design (AQbD), method development and transfer using Design of Experiments (DoE), and a broad range of product characterization services such as pharmacopeial quality control, protein and surfactant analysis, ELISA, nanoparticle measurement, and testing of primary packaging and delivery systems.

With a vision derived from its name — combining the Italian words nuovo (new) and valore (value) — nuvalore creates “new value” by linking science and quality. Its mission is to act as a trusted partner, applying innovative approaches and cutting-edge technologies to accelerate the safe, compliant market entry of client projects.

Privately held and headquartered in Germany, nuvalore operates to the highest regulatory standards, with a QMS aligned to GMP- and ICH- guidelines and is a member of BioRN and Pharma Deutschland.

To learn more, visit: www.nuvalore.com

About Festival of Biologics 2025

Festival of Biologics is one of the world’s premier biologics conferences, bringing together professionals across the biologics development and manufacturing ecosystem to share knowledge, network, and advance the field of biologic medicines.

With hundreds of world-class speakers delivering three days of presentations, panels, roundtables and workshops, this event is the place to keep up with the latest advances across the entire biologics landscape.

The conference covers the complete biologics journey from discovery and development through clinical trials, manufacturing, market access, and fill & finish operations. Across antibodies, immunotherapy and biosimilars, participants share research, create new partnerships, and drive innovation in the biologics industry.

Festival of Biologics is a three-day event opening 30 September until 2^nd October 2025 in Basel, Switzerland.

The event is organised by Terrapinn and will be held at Messe Basel, Hall 1, with further information at: https://www.terrapinn.com