Integrated Molecular Bioanalysis and Immunogenicity

Precision Quantitation Meets Immune Insight

At Franklin Biolabs, we provide fully integrated bioanalytical solutions that combine molecular bioanalysis with immunogenicity and ligand-binding expertise. This complementary approach enables a comprehensive understanding of drug exposure, biodistribution, target engagement, and immune response, supporting confident decision-making from preclinical through clinical development.

Molecular Bioanalysis

Our molecular bioanalysis capabilities deliver highly sensitive and selective quantitation for complex therapeutic modalities:

qPCR and ddPCR assays for nucleic acid–based therapeutics
Biodistribution and tissue analysis
Cell and gene therapy support (vector copy number determination and long-term persistence assessment)
Vector shedding assessments to support gene therapy development and regulatory requirements
mRNA, siRNA, ASO, and gene editing quantitation
High-sensitivity detection in challenging matrices
Robust method development, qualification, and validation

Our molecular platforms provide the sensitivity, precision, and dynamic range required to characterize low-abundance analytes and generate meaningful translational insights across the development lifecycle.

Immunogenicity and Ligand Binding Expertise

We offer comprehensive immunogenicity assessment strategies aligned with regulatory expectations:

Anti-drug antibody (ADA) screening, confirmation, and titer determination
Neutralizing antibody (NAb) assays (cell-based and competitive formats)
PK/ADA integrated assessments
Cytokine and biomarker analysis (ELISA, MSD, multiplex platforms)
Risk-based assay design for novel modalities

Our team brings deep expertise across biologics, bispecific antibodies, cell and gene therapies, and other advanced therapeutic platforms, ensuring scientifically rigorous and regulatory-compliant solutions.

One Study. One Strategy. Fully Integrated.

We uniquely integrate molecular PCR data with immunogenicity outcomes to provide a holistic view of therapeutic performance:

Exposure vs immune response correlations
Persistence and immunogenicity impact assessments
Coordinated study design and sample management
Cross-platform data interpretation and reporting

This unified approach simplifies study execution while delivering clear, actionable insights.

Scientific Partnership

Beyond assay execution, Franklin Biolabs serves as a strategic scientific partner throughout development. Our experts collaborate closely with study teams to optimize bioanalytical strategies, overcome technical challenges, and support successful regulatory outcomes.

Strategic planning for molecular and immunogenicity endpoints
Fit-for-purpose assay selection and study design
Troubleshooting complex bioanalytical challenges
Regulatory support for IND, BLA, and global submissions

Quality, Compliance, and Scalability

Franklin Biolabs maintains robust quality systems and compliant workflows to ensure data integrity, regulatory readiness, and seamless progression from early development through commercialization. Our experience supporting programs across global markets helps sponsors navigate evolving regulatory expectations with confidence.

We offer:

GLP/GCP-compliant operations
21 CFR Part 11 adherence
Experience supporting global regulatory submissions and inspections

Meet Our Team

Lillian Falese

Director, Molecular Bioanalysis

Lillian Falese has over a decade of experience driving bioanalytical and biomarker strategies across preclinical and clinical development, with a strong focus on advanced therapies. As Director of Molecular Bioanalysis at Franklin Biolabs, she leads cross-functional efforts to deliver robust, regulatory-compliant assays spanning cell and gene therapy programs, including molecular, immunogenicity, and complex biomarker platforms. She brings deep expertise in building and managing global CRO and specialty lab networks, enabling scalable, stage-appropriate solutions and guiding clients through complex bioanalytical and regulatory landscapes. Lillian has contributed to landmark gene therapy efforts, including development of immunogenicity strategies for the approved Hemophilia A therapy Roctavian, with work supporting multiple patents and widely cited publications. She is recognized for integrating innovative technologies and mentoring teams to advance high-quality, impactful bioanalytical science.