Bioanalysis measures how much of an active substance or its metabolites is present in blood, plasma, serum, urine or tissue. These concentrations are used to derive pharmacokinetics and toxicokinetics, meaning how a medicinal product is absorbed, distributed and eliminated. Bioequivalence studies for generics rely on such measurements, as does dose finding in early clinical development.
Small molecules are usually measured by liquid chromatography with mass spectrometry, while proteins and antibodies are often measured with ligand binding assays. In addition, many bioanalytical laboratories determine biomarkers and anti-drug antibodies. Different rules apply to these two areas than to drug concentrations, however, and you should keep them apart when awarding the work.
Who needs it
Sponsors of non-clinical and clinical studies, and applicants for generics with bioequivalence studies.
Legal basis
ICH M10 for drug concentrations, plus GLP for toxicity studies and GCP for clinical trials.
Typical scope
Method development, full validation, analysis of study samples and incurred sample reanalysis of selected samples.
What matters
Validation for the right matrix, seamless sample logistics and experience with your type of molecule.
When you need it
Bioanalysis is needed as soon as concentration data feed into a regulatory decision on safety, efficacy or labelling. This starts with toxicokinetic measurements in GLP toxicity studies and continues through all phases of clinical trials, up to comparative bioavailability and bioequivalence studies. For purely exploratory work that is not submitted, you may define the extent of qualification yourself.
Because the method has to be in place before the first study samples arrive, the laboratory is best selected during study planning. Changing laboratories in the middle of a programme is possible, but requires additional validation work so that the data from both laboratories remain comparable.
Legal basis and rules
For drug concentrations, the relevant guideline is ICH M10, which has applied in the EU since 21 January 2023 and replaced the EMA’s earlier guideline on bioanalytical method validation.
ICH M10
Validation of bioanalytical methods and analysis of study samples for chemical and biological drugs and their metabolites, using chromatography and ligand binding assays.
GLP, Sections 19a et seq. of the German Chemicals Act (ChemG)
Non-clinical safety studies must be conducted according to the principles of Good Laboratory Practice. Proof is a certificate issued by the competent authority.
GCP
The principles of Good Clinical Practice apply to samples from clinical trials.
EMA reflection paper from 2012
Expectations of GCP inspectors for laboratories that analyse samples from clinical trials, for example on contracts, sample chain of custody, method validation, repeat analyses, informed consent and confidentiality of trial subjects.
What ICH M10 requires
For the main matrix whose data are submitted, M10 expects a full validation. For chromatographic methods, this includes among other things selectivity, matrix effect, calibration curve and range, accuracy and precision, carry-over, dilution and the stability of the analyte in the matrix. If a validated method is changed or transferred to another laboratory, a partial validation may be sufficient, depending on the extent of the change. If several methods or several laboratories contribute to the reported data, M10 requires a cross validation that shows how the data relate to each other.
A central element is incurred sample reanalysis. At a minimum, it is expected for non-clinical studies once per species, for all pivotal bioequivalence studies, for the first clinical trial in humans, for pivotal early patient trials once per patient population and for the first or pivotal trial in subjects with impaired hepatic or renal function. At least ten percent of the first thousand samples and five percent of the samples beyond that are reanalysed. For chromatographic methods, at least two thirds of the repeats must be within 20 percent, and for ligand binding assays within 30 percent.
Biomarkers and methods for assessing immunogenicity are expressly not within the scope of M10. How far a biomarker method must be validated depends on its purpose in the study and should be agreed early with the laboratory and, where appropriate, with the authority.
How the collaboration works
01
Feasibility
You provide the molecule, expected concentrations, matrix and study design. The laboratory assesses which technique and which lower limit of quantification are achievable and whether reference material is available.
02
Method development and validation
The method is developed, described in a protocol and validated according to M10. The result is a validation report that goes into your submission.
03
Sample logistics
Together you define how samples are labelled, shipped chilled or frozen and logged in the laboratory, so that the sample chain of custody is fully documented.
04
Analysis of study samples
The samples are measured in analytical runs with calibration standards and quality controls. Selected samples are reanalysed on a different day.
05
Bioanalytical report
The report summarises results, deviations, repeat analyses and the results of incurred sample reanalysis, and goes to your pharmacokinetics team and into the study report.
What to look for when choosing a laboratory
Questions to ask the provider
Does the laboratory have experience with your type of molecule, such as small molecules, peptides, oligonucleotides or antibodies?
Does it hold a valid GLP certificate, if your toxicity study requires one?
Does it work according to GCP principles for clinical samples, and has it already been inspected for this?
Which lower limit of quantification can it achieve for your active substance in the required matrix?
How are samples received, stored and monitored, and are there contingency plans for freezers?
Besides drug concentrations, can it also determine biomarkers or anti-drug antibodies, and how does it validate these methods?
How are data integrity and the audit trail secured in the evaluation systems?
How quickly does it deliver results when a dose escalation is waiting for the data?
Frequently asked questions
Does ICH M10 also apply to biomarkers?
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No. M10 expressly excludes biomarkers and immunogenicity methods. Validation depends on the purpose of the measurement, for example whether a biomarker serves only as guidance or supports a decision in the study.
When is incurred sample reanalysis required?
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M10 lists minimum cases, including all pivotal bioequivalence studies, the first clinical trial and non-clinical studies once per species. The extent is at least ten percent of the first thousand samples and five percent of the rest.
What happens if we change laboratories?
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Under M10, transferring a validated method to another laboratory is a typical case for a partial validation. If data from both laboratories are to be evaluated together, M10 requires a cross validation that shows how the results relate to each other.
Does the laboratory need a GLP certificate for clinical samples?
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No. The GLP obligation under Section 19a ChemG applies to non-clinical safety studies. Clinical samples are subject to the GCP principles, which the EMA has set out in more detail for laboratories in a reflection paper. The paper points out that some laboratories apply GLP principles, but that GLP is intended for non-clinical studies and does not cover the safety and rights of trial subjects.
Sources
Every statement in this text was checked against these primary sources (as of 10.11.2026). Laws, guidelines and authority websites, no advertising.
Bioassay GmbH, based in Heidelberg, is a bioanalytical contract research organisation providing potency and safety testing of biologics, as well as HPLC analyses, under GMP and GLP conditions.
Heidelberg
Evidenced
„Bioanalytical contract research services to support your pipeline from discovery to approved product release testing.“
„Unser Leistungsspektrum umfasst die gesamte bioanalytische und molekularbiologische und Auftragsanalytik im GMP-regulierten Umfeld, unabhängig davon, in welcher Phase des Lebenszyklus sich Ihre Produkte oder Projekte befinden.“
ICON Clinical Research Germany GmbH, based in Langen, is a contract research organisation for clinical trials, with a focus on trial planning, monitoring and data management. According to its website, the portfolio also includes bioanalysis and central laboratories.
Langen
Evidenced
„The highest quality services for pharmacokinetic, immunogenicity, and biomarker analysis, utilising a wide range of platforms for small molecules, large molecules, and cell-based entities.“
Labor Dr. Spranger in Ingolstadt is an accredited laboratory that, alongside routine diagnostic testing for physicians, also undertakes analytical commissions for the pharmaceutical industry, including GMP quality control and central laboratory services for clinical trials.
Ingolstadt
Evidenced
„Seit den 1980er Jahren bearbeiten wir analytisch-diagnostische Aufträge der pharmazeutischen Industrie“
MLM Medical Labs GmbH, based in Mönchengladbach, operates a central laboratory for clinical trials, providing sample analysis, biomarker assays and sample storage for pharmaceutical and biotech clients.
Mönchengladbach
Evidenced
„Biomarkers reveal measurable indicators that can show a drug’s efficacy.“
NMI Technologie Transfer GmbH in Reutlingen develops and operates contract research services for pharmaceutical and biotech companies, covering protein profiling, cell assays and electrophysiology, as well as microdevices.
Reutlingen Baden-Württemberg
Evidenced
„Our protein profiling offerings can support Phase I, Phase II and Phase III clinical trials with monitoring pharmacokinetic (PK) and pharmacodynamic (PD) markers.“
Nuvisan GmbH, based in Neu-Ulm, is a contract research organisation (CRO) with laboratories in Germany and France. It conducts clinical trials and recruits trial participants at its own clinical research sites.
Neu-Ulm Bayern
Evidenced
„Nuvisan offers comprehensive bioanalytical and CMC services throughout the entire product life cycle, from early research and development to manufacturing and commercialisation.“
PPD Germany GmbH & Co. KG, based in München, is a contract research organisation (CRO) focused on clinical trials across all phases, supported by biostatistics, data management and functional service partnership models for pharmaceutical and biotechnology companies.
Syneos Health Germany GmbH, based in Munich, is a subsidiary of the global life sciences services organisation and provides clinical trial services (CRO, FSP models) and bioanalytics for pharmaceutical companies.
München
Evidenced
„Syneos Health® Bioanalytical Services offers state-of-the-art bioanalytical technologies and deep scientific expertise supporting complex method development, validation and sample analysis.“
„Hersteller von Biopharmazeutika unterstützen wir in allen analytischen Fragen von der Entwicklung über die Validierung bis hin zur Routineuntersuchung von Testmustern“