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ABOUT · HERITAGE
Our founders pioneered automated particle-resolved Raman analysis in the late 1990s and early 2000s, developing patented workflows that combined particle detection, sizing and automated spectroscopic identification.
Do not only count particles. Identify what they are.
From APSys to rap.ID and today’s SizeID.bio, the analytical goal has remained consistent: connect particle populations to material identity and useful interpretation.
APSys · patented foundations
APSys was founded to bring automated particle detection and material identification into industrial environments. Early patented workflows combined particle detection, sizing and spectroscopic identification — the technical foundation of the workflow later known in the market as MDRS.
First automated particle-Raman prototype
The first stainless-steel, touchscreen-controlled prototype was released in 2001. It marked the beginning of a development path that now spans more than 25 years and seven instrument generations.
Pharmaceutical applications
Automated particle Raman moved into pharmaceutical applications, including OINDP foreign-particle testing, DPI qualification and non-destructive identification of particles in pharmaceutical products.
Selected publications: Niemann & Valet (2005), Valet & Niemann (2006), and Valet & Lankers (2008).
From automation to validated pharmaceutical workflows
Automated imaging, morphology, particle relocation, Raman spectroscopy and database matching matured into controlled pharmaceutical workflows.
Milestones: high-throughput inhalation-particle Raman microscopy (2010), MDI foreign-particulate method validation according to ICH parameters (2011), and chemical characterization of common DPI contaminants (2014).
FDA-inspected rap.ID laboratories
Our rap.ID heritage includes FDA-inspected laboratories in Berlin and Princeton, New Jersey, with no Form 483 observations issued in those inspections.
Ingredient-specific and biologics applications
Krapf, Laskina & Valet demonstrated chemically specific API particle-size distributions in nasal sprays from submicron particles to agglomerates.
Lankers, Valet & Laskina applied Raman spectroscopy to subvisible-particle identification in protein-based formulations. Together, these applications extended the workflow beyond isolated particle identification.
Parenteral particle analysis
Lee, Lankers & Valet published particle identification in parenteral drug raw materials, extending the particle-Raman workflow into another major pharmaceutical application area.
rap.ID acquired by Unchained Labs
In 2018, rap.ID was acquired by Unchained Labs, bringing its particle-identification technology and contract-service business into a larger life-science tools platform.
Systematic MDRS method development
Farias et al. published a systematic approach to developing MDRS methodology for nasal suspension drug products, reflecting the broader regulatory maturation of the technique.
SizeID.bio
That experience now informs a new generation of automated particle Raman analysis: larger particle populations, higher-throughput Raman acquisition, smaller-particle workflows, DeepMorph image-directed targeting and full Test-vs.-Reference/Q3 programs.
GramRay i MK3 carries the current automated particle-Raman workflow.
1999–2001
Patented foundations for automated particle detection, sizing and spectroscopic identification.
2001
First touchscreen-controlled automated particle-analysis prototype.
2005
Automated foreign-particle testing in OINDP.
2006
Particle Explorer qualification for DPI particle counting and identification.
2008
Non-destructive identification of particles in pharmaceutical products.
2010
High-throughput Raman microscopy for concurrent sizing and chemical characterization of inhalation particles.
2011
Raman foreign-particulate method validation according to ICH parameters.
2014
Chemical characterization of common foreign-particle contaminants in DPI products.
2017
Chemically specific API particle-size distribution in nasal sprays.
2017
Subvisible particle identification in protein formulations.
2018
Particle identification in parenteral drug raw materials.
2018
rap.ID acquired by Unchained Labs.
2021
Systematic MDRS methodology for nasal suspension products.
Built through pharmaceutical use at scale
Through rap.ID, the technology was applied across more than 100 pharmaceutical customers, thousands of analytical projects and tens of thousands of particle-analysis runs.
Historical rap.ID experience refers to the predecessor companies and laboratories. SizeID.bio is the current particle-analysis offering of mibiC GmbH & Co. KG.
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