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Bioanalytical Development
Bioanalytical Expertise
Understanding how a drug behaves inside a living system, how fast it's absorbed, how it's distributed, how the body responds to it immunologically, requires a different discipline than standard CMC analytical work. Bioanalytical science deals with complex, variable biological matrices, trace level detection, and data that directly informs dose selection, safety margins, and regulatory decisions about whether a molecule is ready to move into or through the clinic.
PharmiOnyx brings direct bioanalytical experience, including designing and overseeing LC‑MS/MS methods used to characterize PK/TK profiles across biological matrices, and serving as Principal Investigator and Study Director on GLP PK/TK studies with direct responsibility as the primary contact during regulatory audits. PharmiOnyx provides strategic design, protocol and report review, and study oversight, sample testing is carried out by your internal lab or a qualified bioanalytical testing partner.
Bioanalytical Method Development Strategy
We design method development approaches for small molecules, peptides, and biologics in plasma, serum, urine, and other biological matrices, primarily using LC‑MS/MS and ligand binding assay platforms, tailored to the sensitivity and selectivity the program requires, for execution by your testing lab.
Method Validation Protocol Design and Review
We design validation protocols aligned to FDA and EMA bioanalytical method validation guidance, covering accuracy, precision, selectivity, sensitivity, recovery, matrix effect, and stability in the biological matrix, and review resulting data and reports for regulatory defensibility.
PK/TK and PK/PD Strategy
We help design pharmacokinetic and toxicokinetic sampling strategies and bioanalytical plans that generate data fit for dose selection, safety margin determination, and exposure response modeling, informed by direct experience as a Study Director on GLP programs.
Biomarker Strategy and Assay Planning
We support biomarker identification, assay selection, and fit for purpose validation strategy, helping translate biomarker data into decisions that hold up under regulatory and scientific scrutiny.
Immunogenicity Strategy Support
We support strategy development for immunogenicity assays, including ADA and neutralizing antibody assay approach, in alignment with current regulatory expectations for biologics and biosimilars.
GLP Study Oversight and Audit Readiness
We provide Study Director and Principal Investigator level oversight for GLP bioanalytical studies, and serve as the technical point of contact during sponsor and regulatory audits, drawing on direct audit experience from CRO based GLP programs.
Central Lab and Global Clinical Trial Coordination Support
We support bioanalytical operations for global clinical trials, including central lab coordination strategy, sample logistics planning, and cross site data consistency review.
Who we work with: sponsors moving a program from nonclinical into first in human studies who need a defensible PK strategy, biotech teams building an immunogenicity assessment plan for a biologic, and organizations facing a GLP audit who need an experienced Study Director level perspective on their data package.
