Assay ordering, result capture and release.
The analytical work becomes part of the sample's own history: what was ordered, on what instrument, against which specification, and who released the result.
The analysis is the part nobody can trace.
None of this is anyone's fault. It is what happens when the instrument's software and the sample's record are two different systems with a person in between.
- The order is placed by email, or on a worklist nobody else can see
- Results come back as a file, and the link to the sample is a filename
- Specification limits are checked by eye, and the check leaves no record
- Review and release happen where the sample record cannot reach
- A repeat run looks exactly like the original
Ordering, capture, checking and release, on the sample itself.
The analytical work becomes part of the sample's own history rather than a parallel record kept beside it.
Assay ordering and worklists
Tests are ordered against samples that already exist. The worklist is a view of those orders, not a second list somebody keeps in step by hand.
Results land on the sample
A result arrives carrying the instrument, the method, the run and the operator. The link is the record itself.
Specification limits
Limits are configuration, set per study and per method. A result outside them raises an exception with an owner rather than waiting for somebody to notice.
Review and release
Second-person review where the method calls for it, release as a governed act, and a certificate composed from the record rather than retyped into one.
Repeats stay visible
A re-test or re-injection is recorded as one, with its reason, and never quietly replaces what came before. This is the question an investigator actually asks.
Instrument connection
Vendor layouts are mapped as configuration, so a new instrument model is a setting rather than a development release.
Analytical work spans about thirteen method families.
They do not all matter equally to every portfolio, and that is what decides the order they are connected in.
Chromatography and mass spectrometry
LC-MS/MS, HPLC, GC, LC-ICP-MS, size-exclusion chromatography. PK and TK work, quantification, impurity and elemental analysis.
Immunological methods
Flow cytometry, ELISA, electrochemiluminescence, multiplex, immunofluorescence and immunohistochemistry.
Molecular and genetic
qPCR and digital PCR, next-generation sequencing, nucleic acid extraction.
Cell-based and virology
Cell culture and viability, plaque assay and TCID50, neutralizing antibody and T-cell assays.
Protein and biologics characterization
Western blot, intact-protein mass spectrometry, NMR, circular dichroism.
Potency and functional assays
Cell-based potency, surface plasmon resonance, bio-layer interferometry, receptor engagement.
Microbiological and sterility
Sterility testing, endotoxin, microbial identification. Required across every product type.
Physical and chemical characterization
Particle size, thermal analysis, pH and osmolality, elemental analysis.
Biomarker and safety monitoring
Clinical chemistry and hematology, immunogenicity, pharmacodynamic biomarkers.
Pharmacokinetics and toxicokinetics
Bioanalysis for PK and TK, bioequivalence, matrix effects, sample preparation.
Which methods matter depends on what you make.
Connect the ones your portfolio actually runs on, in that order.
| Method | Biologics | Small molecules | Vaccines |
|---|---|---|---|
| LC-MS/MS | Common | Primary | Occasional |
| Flow cytometry | Common | Rare | Common |
| ELISA | Common | Occasional | Primary |
| HPLC | Common | Primary | Occasional |
| Bioassay / potency | Common | Occasional | Common |
| Sterility testing | Required | Required | Required |
| Immunogenicity | Common | Rare | Primary |
| Cell culture | Common | Common | Common |
| NGS | Growing | Occasional | Growing |
| NMR | Growing | Common | Rare |
Where we start.
Three families carry the most weight across biologics and vaccines.
Flow cytometry
Common for biologics and for vaccines, and high volume wherever it is used at all.
LC-MS/MS bioanalysis
Primary for small molecules and common for biologics. The core PK and TK tool, and the densest source of result data.
Immunoassays
ELISA is primary for vaccines and common for biologics, with electrochemiluminescence as the higher-sensitivity variant.
Tell us which instruments matter most.
The order these are connected in should follow your portfolio, not our roadmap. We will walk what exists today and be specific about the rest.