Scale-Up
Successfully Scale from Clinical to Commercial Manufacturing
When your CDMO is struggling to scale from clinical to commercial volumes, GMPKit deploys our proven approach, process development experts, and operational frameworks to achieve successful scale-up in 120 days.
The Scale-Up Problem
Scaling from clinical to commercial manufacturing requires more than just larger equipment—it demands process optimization, operational readiness, and the systems to execute with reliability.
Scale-Up Delays
Your CDMO is struggling to scale from clinical to commercial volumes—missing timelines, failing batches, and frustrating innovator clients.
Process Capability Issues
What worked at clinical scale doesn't translate to commercial volumes—process parameters need optimization, equipment constraints emerge, and yields drop.
Operational Readiness Gaps
Your team lacks the systems, skills, or capacity to execute commercial-scale manufacturing with the reliability and predictability clients expect.
How GMPKit Solves This
We solve scale-up problems by applying our proven approach and GMPKit toolset to your specific situation—combining process expertise, operational frameworks, and strategic execution.
Deploy Scale-Up Strategy
We translate your scale-up targets into deployable execution plans—establishing clear timelines, resource requirements, and success criteria for clinical-to-commercial transition.
Learn About Strategy DeploymentDiagnose Scale-Up Constraints
We use our diagnostic frameworks to identify where scale-up is breaking—process capability, equipment constraints, workflow bottlenecks, or operational readiness gaps.
Explore Diagnostic FrameworksOptimize Process Parameters
We deploy process development experts to validate scale-up parameters, optimize batch sequencing, and ensure process capability at commercial volumes.
Learn About Our SME NetworkImplement Operational Systems
We design governance systems and deploy BatchTrak™ to ensure your operations team can execute commercial manufacturing with discipline and accountability.
Learn About Governance SystemsExpert Intervention When Needed
Our experience, tools, and SME network help us solve scale-up problems quickly—deploying process development and operations experts to accelerate commercial readiness.
Validation Strategy Experts
We deploy validation specialists to design scale-up validation strategies, ensure process qualification, and support commercial readiness.
Manufacturing Experts
We bring in experienced manufacturing leaders to build front-line capability and implement the operational systems needed for commercial-scale execution.
Quality System Architects
When quality systems need strengthening for commercial scale, we deploy QA experts to design robust batch review and disposition workflows.
Results You Can Expect
By day 120, you'll have successfully scaled to commercial volumes with validated processes, operational systems, and the confidence of your innovator clients.
- Successful scale-up in 120 days
- Validated process parameters at commercial volumes
- Improved batch success rates during scale-up
- Operational systems ready for commercial manufacturing
- Client confidence in CDMO partnership
Getting Your Strategy Back on Track:
Our experience, tools, and SME network help us solve scale-up problems quickly—getting your CDMO strategy back on track and delivering the commercial manufacturing capability your innovator clients need to bring therapies to patients.
Ready to Scale to Commercial Manufacturing?
When your CDMO is struggling to scale from clinical to commercial volumes and innovator clients are losing confidence, let's discuss how GMPKit can deploy our proven approach to achieve successful scale-up in 120 days.