Incoming materials are tested against predefined specifications to confirm identity, quality, and suitability before use in manufacturing


Robust analytical testing is fundamental to successful biomanufacturing. Nexus Bioworks provides comprehensive analytical methods to support raw material qualification, in‑process monitoring, and final product release, ensuring critical quality attributes are verified at every stage of your program.
Operating from FDA-registered facilities in the U.S., and under ISO 13485:2016 and ISO 9001:2015 certified quality management systems, our analytical activities are aligned with cGMP requirements and fully integrated into our manufacturing operations.
We develop and execute approved transfer protocols, followed by fully defined testing plans covering raw materials, in‑process controls, and final product release, ensuring transparency and alignment with your quality expectations from day one.
Our on‑site analytical laboratories support a wide range of testing requirements, providing end‑to‑end analytical coverage throughout development and commercial manufacturing:
All analytical methods are transferred into our facility during the Technical Transfer phase of your project, enabling efficient decision‑making, timely product release, and consistent compliance throughout the product lifecycle.
Our analytical infrastructure supports method development, transfer, validation, and routine testing, enabling reliable execution from early‑stage programs through to commercial manufacture.
| Analytical technique | Representative systems |
|---|---|
| Chromatography | HPLC / UHPLC platforms |
| Detection & assays | Microplate readers, UV/Vis systems |
| General analytics | TOC analyzer, osmolality and conductivity meters |
| Imaging & inspection | Microscopes |
| Stability | Controlled stability chambers |
| Analytical technique | Representative systems |
|---|---|
| Chromatography | HPLC / UHPLC platforms |
| Detection & assays | Microplate readers, UV/Vis systems |
| General analytics | TOC analyzer, osmolality and conductivity meters |
| Imaging & inspection | Microscopes |
| Stability | Controlled stability chambers |
See how our flexible biomanufacturing solutions are helping our clients take their molecules from
discovery to commercial scale manufacture.
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