From Validated Process to Production

Dakota BioWorx provides contract bio-manufacturing for teams who need dependable production, disciplined quality systems, and a partner built for long-term supply.

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Bio-Manufacturing You Can Rely On

Once your process is validated you need product manufactured on specification. Delivered on schedule. Supported by documentation that holds up under scrutiny. That’s the level of execution Dakota BioWorx delivers.

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We Dakota BioWorx Delivers

Contract manufacturing built around specification, consistency, and dependable delivery.

Production on Specification

Batch-To-Batch Consistency

Disciplined Recordkeeping

Reliable Scheduling & Delivery

Reliable Production at Scale

Your process is proven. Now it needs to perform at scale, without surprises. Dakota BioWorx is the bridge forward for biotech teams looking for dependable production.

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Our Proven Process

Reliable production doesn’t happen by chance. It’s the result of structured planning, disciplined execution, and rigorous documentation.

Assess & Align

We start by aligning on technical goals, timelines, and IP protection so your science is protected as we move it forward.

Prepare & Validate

We confirm raw material sourcing, equipment readiness, documentation workflows, and quality checkpoints before production begins.

Execute with Discipline

Production runs are carried out to defined specifications, supported by in-process controls and structured documentation at every step.

Verify & Deliver

Each batch is reviewed against specification, fully documented, and scheduled for dependable delivery—so product arrives as expected.

When it has to be right, every time.

Schedule a free manufacturing consultation to discuss how we can support on-spec production, disciplined quality systems, and reliable delivery.