Bioanalytical expertise for every stage of development

From preclinical studies through late-phase clinical trials, our bioanalytical solutions deliver the high-quality data needed to evaluate drug exposure, support regulatory submissions, and drive confident development decisions.

bioanalytical-1

Comprehensive capabilities

We offer a full suite of bioanalytical solutions to support small molecules, biologics, vaccines, and advanced modalities, including cell and gene therapies.

Capabilities include:

  • Quantitative and qualitative biomarker analysis

  • Pharmacokinetic (PK) and toxicokinetic (TK) studies

  • Immunogenicity and neutralizing antibody (NAb) assessments

  • Cell‑based and ligand‑binding assays

  • Genomic and molecular assays for persistence, shedding, and vector detection

  • Viral and microbiological testing supporting infectious disease and vaccine programs

Regulated support

Our laboratories operate under GLP and GCP principles, using validated methods designed for reliability, sensitivity, and consistency. We support:

  • Assay development and optimization

  • Method transfer and bridging

  • Pre-clinical through post-marketing clinical trial testing

  • Stability, matrix, and reproducibility evaluations

  • FDA/EMA readiness and documentation alignment

bioa-qa
cell-based-assays-1

Specialty expertise

Our scientists have deep experience in complex matrices, low‑abundance targets, and challenging assay systems. Whether assessing immunogenicity risk, quantifying vector‑based therapies, or monitoring vaccine responses, we provide solutions tailored to your program’s scientific and regulatory needs.

Advanced platforms

Our labs are equipped with a broad range of analytical technologies, including:

  • Ligand‑binding platforms (ELISA, multiplex)

  • Flow cytometry and immune profiling

  • qPCR/dPCR molecular platforms

  • Cell‑based and functional assays

  • Sequencing and high‑sensitivity detection methods

pcr-samples
bioa-team

Designed for clinical trial success

Every study benefits from proactive scientific consultation, responsive communication, and collaborative planning. We deliver data packages and reports purpose‑built to support regulatory submissions, protocol compliance, and confident decision‑making at each study milestone.