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    • Upstream Processing 
      Enable stepwise, risk-controlled scale up of microbial bioprocesses, from benchtop through to commercial scale fermentation with flexible capacity that grows alongside your program.
    • Downstream Purification 
      Deliver target yield, purity, and performance through custom downstream solutions, engineered to align with your specifications and optimize every stage of your process for consistent, reliable results.
    • Analytical Testing 
      Ensure confidence at every stage with structured, risk-managed transfer, qualification, and validation of analytical assays for raw material inspection, in-process analysis, and final product release.
    • Formulation & Final Product Processing 
      Streamline production with integrated formulation, bulk lyophilization, and fill-finish services, enabling efficient progression from pilot batches to high-volume output with consistent quality and reliability.
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Analytical Testing

Deliver confidence in product quality with robust analytical testing integrated
across development, manufacturing, and release

Integrated analytical insight to support
quality, consistency, and compliance

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.

Analytical expertise across the product lifecycle

Our on‑site analytical laboratories support a wide range of testing requirements, providing end‑to‑end analytical coverage throughout development and commercial manufacturing:

Raw material verification

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

In‑process testing

Analytical monitoring throughout production supports process control, early issue identification, and informed decision‑making during manufacturing

Final product release

Robust release testing confirms product quality, purity, and compliance with agreed specifications prior to batch release

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 techniqueRepresentative systems
ChromatographyHPLC / UHPLC platforms
Detection & assaysMicroplate readers, UV/Vis systems
General analyticsTOC analyzer, osmolality and conductivity meters
Imaging & inspectionMicroscopes
StabilityControlled stability chambers
Analytical techniqueRepresentative systems
ChromatographyHPLC / UHPLC platforms
Detection & assaysMicroplate readers, UV/Vis systems
General analyticsTOC analyzer, osmolality and conductivity meters
Imaging & inspectionMicroscopes
StabilityControlled stability chambers

Comprehensive in‑house testing

Integrated analytical laboratories support raw material testing, in‑process monitoring, and final product release, providing end‑to‑end oversight of critical quality attributes.

Faster turnaround times

With analytical testing embedded within our manufacturing operations, results are delivered efficiently, reducing reliance on external testing and minimizing release delays.

Seamless method transfer

Structured transfer protocols and experienced analytical teams enable rapid onboarding of client methods, reducing implementation risk and supporting smooth technology transfer.

Product quality and consistency

Robust analytical verification helps ensure batch‑to‑batch consistency, product integrity, and compliance with predefined specifications.

Data‑led process optimization

Analytical insights can be leveraged to refine processes, improve yields, and enhance overall manufacturing performance.

Partner with Nexus Bioworks for scalable microbial biomanufacturing

Partner of choice for analytical testing

See how our flexible biomanufacturing solutions are helping our clients take their molecules from
discovery to commercial scale manufacture.

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Partner with Nexus Bioworks for scalable microbial biomanufacturing