Process-Specific HCP ELISA Highlights Trend Toward Tailored Biopharma Analytics

A new partnership between France-based Naobios (Clean Biologics Group) and Olon France (part of Olon Group), announced on Oct. 2, 2025, aims to create a process-specific host cell protein (HCP) enzyme-linked immunosorbent assay (ELISA) kit designed to support the production of a viral vaccine entering Phase I clinical trials in late 2026. The collaboration addresses a gap in available analytical tools, as no commercial HCP ELISA kits exist for the cell strain used in this vaccine’s program (1). Such solutions are critical to maintaining development timelines, securing reliable supply chains, and ensuring regulatory compliance (2).

“Olon France is proud to join forces with Naobios to deliver a fully customized HCP ELISA solution, ensuring reliable analytics and supply for our client’s innovative vaccine program,” said Jérôme Bedier, CEO of Olon France, in a company press release (1). “This partnership demonstrates our agility and commitment to advancing complex clinical projects on a global scale.”

Why are process-specific HCP assays important in biopharmaceutical development?

HCP assays are essential in biologics and vaccine manufacturing to monitor and control process-related impurities that can affect product quality, safety, and efficacy. In this case, a process-specific ELISA was necessary to provide reliable detection of host cell proteins not covered by standard commercial kits. This approach ensures that vaccine developers can qualify industrial processes early, while also establishing a framework for consistent testing throughout the lifecycle of the program, according to Naobios in the release (1).

The collaboration between Naobios and Olon France reflects a broader trend within the biopharmaceutical industry driven by the increasing need for tailored analytical methods as vaccine and biologics programs diversify beyond standard production systems. For biomanufacturers, such solutions mitigate risks of supply disruption and regulatory delays, which can otherwise slow the progress of clinical trials and impact downstream manufacturing strategies (3).

What steps are the companies taking to develop this assay so it aligns with clinical timelines?

The collaboration project is structured in two phases. First, a fast-track HCP ELISA is being developed to allow early detection of host cell proteins during process development. This step enables qualification of the industrial process without delaying clinical trial initiation. The second phase will produce a fully validated process-specific ELISA that will be optimized for good manufacturing practice release testing of clinical batches.

The companies noted in the release that this phased approach aligns with a growing industry emphasis on flexibility in development. Their approach balances the need for rapid clinical progress with the requirements of long-term regulatory compliance and manufacturing consistency. Alongside assay development, Naobios and Olon France are jointly managing HCP material production to ensure robust and reproducible results from the outset (1).

“Partnering with Olon France enables us to strengthen our offering and deliver reliable analytical solutions to our clients,” said Eric Le Forestier, managing director, Naobios, in the release. This collaboration exemplifies how French expertise can contribute to international clinical programs.”

What does this project mean for the biopharma ecosystem?

Beyond the immediate project, the partnership highlights the strength of the French biopharmaceutical sector. Both Naobios and Olon France are members of France BioLead, an initiative that fosters collaboration within the country’s manufacturing and development ecosystem (4). The companies’ joint effort demonstrates how local expertise can integrate into global development pipelines, offering specialized capabilities to international programs (1).

For the wider biopharma industry, the collaboration underscores the importance of investing in process-specific analytics as biologics become increasingly diverse. By securing long-term availability of assay kits and reagents, vaccine developers can minimize risks associated with process variability, regulatory audits, and global supply constraints. This reliability not only protects clinical timelines but also strengthens the overall resilience of biopharmaceutical manufacturing strategies (5).

References

1. Naobios. Naobios and Olon France Partner to Deliver Process-Specific HCP ELISA for an International Academic Institute. Press Release. Oct. 2, 2025.
2. Pilely, K.; Johansen, M. R.; Lund, R. R.; et al. Monitoring Process-Related Impurities in Biologics—Host Cell Protein Analysis. Anal. Bioanal. Chem. 2022, 414 (2), 747–758. DOI: 10.1007/s00216-021-03648-2
3. Dream, R. The Use of Analytics in Biopharmaceuticals: An Introduction. BioPharm International 2025, 38 (4), 19–23.
4. France BioLead. What is France BioLead?france-biolead.fr (accessed Oct. 2, 2025).
5. NIAID. Product Development Plan for a Generic Prophylactic Vaccine for Infectious Diseases. niaid.nih.gov, Aug. 28, 2023.