Choosing bioanalytical services: what method validation commits a bioanalytical laboratory services provider to, how a pharmacokinetic assay is specified against the study it supports, and the questions that separate bioanalytics services able to defend a dataset

Specifying the work

1. Decide the regulatory context before the assay. A discovery screen, a study supporting a regulatory submission and a clinical trial sample analysis are three different exercises with the same chromatogram. The context decides whether a fit for purpose qualification suffices or a full validation is required, and it decides the price.
2. Fix matrix and species at the outset. An assay validated in one species' plasma is not validated in another, and anticoagulant, haemolysis and lipaemia all change recovery. Supply real matrix from the intended species early so selectivity is established on it rather than on a surrogate.
3. Agree the calibration range against the expected exposure. A range that does not bracket the concentrations that occur means dilutions, repeats and delay. Model the expected profile before the range is set, and agree how out-of-range samples will be handled.
4. Require stability data that matches the real sample journey. Bench top, freeze-thaw, long term storage and whole blood stability have to cover the handling the samples will actually see, including the courier leg. Stability gaps found after collection cannot be fixed retrospectively.
5. Confirm incurred sample reanalysis is planned. Reanalysing a subset of real study samples is what demonstrates the method works on the samples rather than on spiked standards. It is an expectation in regulated work and a good idea in every other kind.

Large molecule against small molecule

Small molecule work is dominated by chromatography with mass spectrometric detection and the validation expectations are well settled. Large molecule work is usually ligand binding, where critical reagents are the risk: a depleted lot of capture antibody can end an assay's life mid-study.

For ligand binding assays, ask about critical reagent management specifically. A provider that banks and bridges reagent lots has thought about the problem; one that orders as needed has not.

Sample logistics

Chain of custody, shipping temperature records and receipt condition documentation are part of the dataset. A shipment that arrived warm and was analysed anyway is a finding waiting to be made, and the decision has to be recorded at the time.

Agree the sample inventory format and reconcile it at receipt. Discrepancies between the site's list and the laboratory's receipt are common and much easier to resolve in the first week than at report.

Reading the report

The report should state the validated range, the runs accepted and rejected with reasons, the calibration and quality control performance, and any repeat analyses with the rule that authorised them. A report with only concentrations is not reviewable.

Ask for the data in an analysable format alongside the document. Modelling teams reading numbers off a portable document is a recurring and entirely avoidable source of transcription error.

Common questions

What is included in bioanalytical services?

Method development, validation or qualification, sample receipt and storage, analysis, data review and reporting. The price per sample generally excludes the validation, which is a separate and larger item.

When do I need full validation rather than a qualification?

When the data supports a regulatory submission or a clinical decision. Discovery work is usually served by a fit for purpose qualification, and upgrading later means revalidating rather than extending.

What is a pharmacokinetic assay expected to deliver?

Concentrations with defined accuracy and precision across a range that brackets the observed exposure, in the study matrix, with documented stability covering how the samples were handled from collection to analysis.

How do I compare quotes from two bioanalytics services providers?

Normalise the scope: validation extent, number of analytes, sample volume, turnaround, repeat policy, incurred sample reanalysis and reporting format. Per-sample prices for different scopes are not comparable and almost never are.

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