Rescuing a Pilot Study: How a Coordinated Response From CellCarta Kept a Critical Program on Track

Even the most carefully designed early-stage programs can encounter challenges that threaten to disrupt progress. When they do, resolving the issue quickly is essential to keeping research on track.

That was the case during a Lunaphore COMET-based multiplex immunofluorescence pilot study conducted at CellCarta’s California, Lake Forest laboratory. Following initiation of the project, it was discovered that the originally sourced samples did not meet the study’s unique requirements, placing the continuation of the pilot in doubt.

This case study examines how coordinated scientific and operational expertise helped restore continuity and preserve study momentum.

The Study: Developing a COMET-Based Multiplex Panel

CellCarta was engaged by a big pharma company to provide multiplex immunofluorescence testing and data analysis, and to evaluate the capabilities of the Lunaphore COMET platform.

To support this objective, the Lake Forest team initiated development of an 8-plex multiplex immunofluorescence (mIF) assay on the Lunaphore COMET platform, incorporating key immune markers: FoxP3, CD8, CD4, CD20, CD3, CD56, CD68, and Ki67.

In parallel with wet lab assay optimization, digital image analysis workflows were developed using HALO AI HighPlex FL, including AI-driven nuclear segmentation to support accurate cell phenotyping and quantification.

Assay development and algorithm optimization were progressing as planned when an unexpected complication emerged.

The Challenge: An Unexpected Compliance Obstacle

Immediately after study initiation, the client informed CellCarta that their procured samples had been collected under IRB-waived consent rather than full informed consent.

As the study required samples that met defined informed consent criteria, the existing materials were no longer suitable for use. With assay development and algorithm optimization already underway, the stakes were high: cancellation would not only have halted the pilot but delayed the customer’s broader technology and vendor assessment program — pushing back critical decisions about their future multiplex immunofluorescence strategy.

The Response: End-to-End Collaboration

To preserve the pilot, the CellCarta Lake Forest team moved quickly to identify an alternative path forward. Replacement tissue samples meeting the study’s informed consent requirements were sourced through a preferred vendor within one week — but the speed of procurement was only part of the challenge.

Because study activities had already begun, the sample swap triggered a coordinated restart across assay development, pathology, digital pathology, procurement, and project management functions to realign the study materials and maintain continuity.  Despite the steep operational hurdles involved, the customer experienced no delays and no degradation to the study.

Maintaining Progress Through Unexpected Disruption

Scientific innovation depends on momentum. When unforeseen challenges arise, biopharma companies need more than scientific expertise from their CRO partners; they need flexibility and coordinated problem-solving to keep studies moving forward.

The Lake Forest team’s integrated approach to assay development, digital pathology, and sample sourcing ensured that this COMET-based pilot could continue as intended. For sponsors navigating complex spatial biology studies, that responsiveness matters.

Working on an early-stage program?

Connect with CellCarta’s Lake Forest team to discuss how we can support your next milestone.

About CellCarta’s California, Lake Forest Laboratory

For over 20 years, CellCarta’s CLIA and CAP-accredited Lake Forest laboratory has supported pharmaceutical and biotechnology sponsors across preclinical, discovery, and clinical development programs. Key capabilities include:

• Multiplex immunohistochemistry and immunofluorescence expertise
• Integrated digital pathology and spatial analysis workflows
• In-house tissue biobank access
• Rapid turnaround times designed for early-stage decision-making

Since its opening, the Lake Forest team has worked with over 230 sponsors on over 2,400 unique projects. Operating independently and capable of participating in multi-site joint studies, Lake Forest delivers the speed and flexibility required to advance early-stage programs with confidence.