Inventing CSPS | MDRS
About SizeID.bio
Who we are
We are Markus Lankers and Oliver Valet, co-founders of mibiC and inventors of Chemical-Specific Particle Sizing (CSPS) at rap.ID — the method later adopted industry-wide as MDRS. For more than 20 years, we have been working with regulators and the pharmaceutical industry.
Together with a dedicated team of engineers, scientists, and regulatory experts, we continue to develop and refine the mibiC technology platform — advancing the science of in-vitro bioequivalence testing.
At the heart of this work is the GramRay — the most powerful, DeepMorph-supported MDRS instrument.
GramRay combines cutting-edge optics, AI-driven Raman intelligence, and validated regulatory workflows to deliver the statistical strength and analytical clarity that define SizeID.bio services.
With mibiC, we have integrated sub-micron accuracy, built-in calibration controls, and an optimized particle-tracking architecture for higher reproducibility and traceability.
DeepMorph extends far beyond conventional machine vision and 2D morphology: it merges shape analysis with chemical selectivity from Raman spectra, providing unmatched sensitivity and specificity in distinguishing API from carrier and quantifying nano- and microparticles with regulatory confidence.
At SizeID.bio, we transform complex particle data into regulatory evidence — enabling faster approvals, fewer agency questions, and earlier patient access.
Our Legacy
Our story began with the founding of rap.ID, where we developed CSPS — a method that became widely recognized as MDRS. From those early days, our mission has been constant: to provide regulators with particle data they can trust.
Over the years, we have supported successful FDA bioequivalence dossiers for nasal sprays and topical suspensions, and our laboratories in Berlin and Princeton have passed rigorous FDA inspections. Alongside this regulatory track record, we have worked with more than 100 clients, including many of the world’s leading pharmaceutical companies, helping them navigate complex challenges.
Out Work Across Modalities
Our expertise spans the full spectrum of complex drug products. We began with dry powder inhalers (DPIs), where release testing and particle-size characterization are essential to demonstrate performance and ensure batch-to-batch consistency. We then extended our methods to nasal sprays, generating datasets that align with the FDA’s newly defined in-vitro–only bioequivalence pathways.
Today, our work also includes topical suspensions and creams, where dissolution and IVRT studies must be closely linked to particle-size analysis, and parenteral formulations, where identifying and characterizing sub-visible particles and bioburden are critical for quality and patient safety.
Beyond finished-product testing, we support lifecycle studies and particulate matter (PM) assessments across raw materials, components, and assembly parts, ensuring control and traceability from material sourcing to final release.
Our platforms also enable foreign particulate matter investigations, method development (MD) and method validation (MV), as well as routine release testing where required.
By applying a consistent approach — robust particle data, validated SOPs, and regulator-ready reporting — we provide evidence that withstands FDA and EMA scrutiny across all modalities and product stages.
Our BE Approach Today
At SizeID.bio, we push MDRS further — from method to science.
We advance Chemical-Specific Particle Sizing (CSPS)/MDRS into the sub-micron range, combining precision Raman analytics with high-throughput imaging and AI-driven classification to strengthen the scientific foundation of in-vitro bioequivalence.
10,000+ particles per run — threefold stronger statistics than industry norms.
Single-sample integrity — full datasets without stitched runs.
USP <858>-aligned quality control — built-in signal-to-noise verification.
ISO 9001-certified laboratory — validated SOPs, FDA/EMA-ready.
Dossier-ready deliverables — structured to pre-empt reviewer questions and accelerate approvals.
At SizeID.bio, every dataset is designed to hold up under scientific and regulatory scrutiny — providing the quantitative confidence that drives faster approvals and earlier patient access.