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CDMO Services
Quality Control Testing & Stability
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Quality Control & Stability Solutions for Cell Therapies

Protect what matters, with specialized testing for living cell products.

About

You get comprehensive quality control testing and stability studies tailored specifically for cell therapy products.

Whether that’s identity and potency measures or sterility and shelf-life, our testing strategies are designed to preserve product quality, meet regulatory standards, and support clinical and commercial advancement.

Services

  • Comprehensive QC testing designed for cell therapy products

  • Analytical and microbial methods for release and characterization

  • Phase-appropriate method validation

  • Cell-specific potency and functional assays

  • Customized ICH-compliant stability programs

Regulatory-Ready Testing

Our quality control testing capabilities help your cell therapy products meet safety, identity, purity, and potency requirements.

Lot and Patient Batch Release

Comprehensive testing to meet regulatory requirements.

  • Identity, potency, purity, and safety testing

  • Flow cytometry, qPCR/ddPCR, ELISA, cell-based assays

  • Full GMP documentation and batch record review

Safety Testing

Checks for timely product release.

  • Sterility and endotoxin testing

  • Mycoplasma detection

  • Adventitious agents testing

  • Residual materials testing

Identity Testing

Confirming what the product is.

  • Immunophenotyping

  • Genetic identity testing

  • Cell surface marker analysis

  • Morphological assessment

Purity Testing

Confirming what's in the product.

  • Cell population purity

  • Viability assessment

  • Process-related impurities

Potency Testing

Confirming that the product works.

  • Functional cell-based assays

  • Cytokine production analysis

  • Gene expression analysis

  • Cell proliferation and activation assays

Stability Programs

Customized programs for shelf-life determination and extension.

  • ICH-compliant stability programs

  • Stability-indicating methods

From concept to compliance

Our testing experts develop, qualify, and validate methods specifically designed for cell therapy products.

Design of cell-specific assays addressing unique product attributes, development of stability-indicating methods, and potency assay development appropriate to mechanism of action, optimized for reproducibility, specificity, and sensitivity.

See Process & Analytical Development
A Made Scientific QC lab with cold storage

Phase-appropriate qualification and validation in alignment with ICH Q2(R1) guidelines, comparability and transfer studies across manufacturing sites, and complete documentation supporting regulatory submissions.

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Why Made Scientific for Quality Control

Cell therapy focus

Specialized methods optimized for cellular products.

Method flexibility

Customized approaches for unique product attributes.

Integrated solutions

A connection between manufacturing and testing.

Risk-based approach

Testing strategies appropriate to development stage.

Quality Control Insights

Technical perspectives from Made Scientific.

Rethinking sterility assurance

A Made Scientific article on sterility assurance for short-life cell therapies.

Read Article

Structuring your quality by design framework

A Made Scientific article on building quality by design into cell therapy development.

Read Article

Eleven manufacturing considerations for your MSC program

A framework for teams planning their MSC manufacturing strategy.

Read Article

Made is easy to work with. We’ve got your back.

We work as an extension of your team. Cell therapy development is rarely linear, so our engagement models are designed to flex with your program as timelines shift and data evolves.

Traditional & Dedicated Service

All Clients

We provide end-to-end solutions with platform processes or purpose-built technology transfer, plus dedicated capacity models to secure your supply chain.

Hybrid Client-In-Plant Operations

Mid-to-Late Stage Clients

We get you started, then step back. GMP-ready labs, cleanrooms, and equipment are available in shared or dedicated settings, supported by specialized experts.

Custom Build-outs & Partnerships

Late-Stage and Commercial Clients

We collaborate on custom lab, cleanroom, warehousing, and cold-chain solutions tailored to your workflow and spatial needs in our expansion areas.

Scientist loading a sample into an analytical instrument
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Ready to Talk About Your Testing Strategy?

Connect with our team to discuss quality control testing and stability studies for your cell therapy.

Example page for review. Not published by Made Scientific.