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About Analysis Zero

Analysis Zero is a real-time quality control platform for biomanufacturing, spun out from deep CMC and PAT expertise. Backed by the FDA (CBER) and the Gates Foundation, we build the hardware-enabled SaaS stack that moves quality control inside the manufacturing suite โ€” eliminating the "Manual Tax" that makes biologics slow, expensive, and inaccessible. Our platform combines a deployable PAT skid (backed by a Type II Drug Master File), a Chemometrician AI for real-time spectral model development, and a CMC intelligence layer that turns process data into regulatory-ready decisions.

Leadership

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Aaron B. Cowley

PhD, MBA  ยท  Chief Scientific Officer

Aaron leads scientific strategy and commercial development. He brings deep expertise in spectroscopy, PAT implementation, and FDA regulatory strategy, with a track record of deploying real-time release testing programs across biologic modalities.

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Edita Botonjic-Sehic

PhD  ยท  Head of PAT & Digital Strategy

Edita drives PAT strategy and the digital intelligence roadmap. Her background in spectroscopic analytics and process optimization spans development-stage biologics through commercial manufacturing, with particular depth in LNP and mRNA modalities.

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Mark Jandreski

MS ChE  ยท  Head of Process & System Architecture

Mark leads platform architecture, software development, and systems integration. He brings process engineering depth combined with modern software infrastructure, connecting the PAT hardware layer to the digital intelligence platform.

Backed by a full technical team spanning process engineering, data science, CFD modeling, and industrial automation โ€” with the cross-functional depth to move from molecule to manufacturing suite.

Backed by Regulators and Philanthropists

Our $82M CBER Program and Gates Foundation backing reflect confidence in the platform's ability to make biomanufacturing faster, more accessible, and more reliable across modalities.

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