Bioanalytical Testing

Services to scope with a provider

• LC-MS/MS assay development for small molecules and metabolites in biological matrices; define selectivity, calibration range and matrix effects.
• PK/TK study-sample analysis with sample tracking, run acceptance, stability coverage and incurred sample reanalysis where applicable.
• Ligand-binding assays for biologics, with reagent characterization and assay-specific validation strategy.
• Biomarker assay development and qualification tailored to intended use; exploratory biomarker work is not automatically an ICH M10 validation exercise.
• Research cell-line and reagent qualification: specify identity, species, passage history, intended assay and contamination risk. STR profiling is appropriate for authentication of many human cell lines, not a universal identity method for every species or primary culture. Mycoplasma testing, identity testing and adventitious-agent assessment answer different questions.

Typical use cases

• Nonclinical toxicokinetic support
• Clinical pharmacokinetic sample analysis
• Method transfer and bridging between laboratories
• Exploratory biomarker measurement

Methods, standards and scope

These are general scope summaries, not standards text or a claim about the current edition. Confirm the required edition, local adoption, method suitability and the provider's specific accredited or authorized scope before ordering.

• ICH M10 addresses bioanalytical method validation and study-sample analysis for relevant drug-development studies, including chromatographic and ligand-binding methods. Confirm applicability to the study and analyte.
• Discuss accuracy, precision, selectivity, sensitivity, calibration, carryover, dilution integrity and stability. Validation design differs by assay and matrix.
• Specify anticoagulant, collection tubes, storage, freeze/thaw exposure, sample volume, shipping temperature and chain of custody before the laboratory accepts samples.

Prepare a useful request

• Analyte(s), species, matrix and expected concentration range
• Study type, regulated context and sample count
• Sampling/storage history, required reporting and timeline
• For research cell lines or reagents: supplier/catalogue identifier, lot, provenance and permitted use, certificate of analysis, authentication record, passage history, storage and shipping requirements. Confirm provider acceptance before sending biological material. Sourcing is an inquiry, not an available-stock or manufacturing claim.

From request to provider proposal

• Describe your samples, objective, method and timeline once.
• Laboratory Vortex reviews the request and may ask for clarification.
• Independent providers assess feasibility and propose scope, sample requirements and pricing.
• You confirm qualification, confidentiality and contract terms with the provider. Laboratory Vortex does not test samples, issue reports or guarantee quotes or turnaround.