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MSC Development and Manufacturing

Your mesenchymal stem cell (MSC) work is promising. The manufacturing challenge is making it perform the same way, every time, at every scale.

About

Made Scientific is a cell therapy CDMO with active MSC programs spanning early clinical development, GMP manufacturing execution, and commercial readiness.

MSC programs carry a specific manufacturing risk profile: donor variability, sensitivity to handling, and scale-dependent shifts in cell behavior that surface late and cost time. We work with sponsors to confront those risks early, designing processes where manufacturing control and biological complexity are engineered together rather than corrected later.

What differentiates our approach:

  • Purpose-built specifications aligned for MSC biology, donor variability, and scale

  • Stage-appropriate process and analytical strategies that evolve with your program and support comparability across phases

  • Integrated development, manufacturing, and quality teams for few handoffs and fewer surprises

  • Infrastructure qualified to support clinical progression and structured for long-term commercial supply

Services

We provide end-to-end operational support for autologous and allogeneic MSC programs, from initial process execution through GMP release and commercial supply. These services are grounded in active MSC manufacturing programs that span early clinical execution through structured multi-batch GMP supply.

MSC services include

  • Starting material sourcing, donor qualification, and MSC cell banking
  • Process and analytical development aligned to potency strategy and phase-appropriate control
  • GMP drug substance and drug product manufacturing with defined batch execution and release oversight
  • Aseptic fill-finish across vials, cryovials, bags, and bulk formats, including cryogenic handling workflows
  • Lot release, stability programs, and quality testing under GMP quality systems
  • Flexible engagement models, from defined-scope technical support to fully integrated development and manufacturing partnerships

 

Our Capabilities

We support MSC programs with stage-appropriate development, GMP manufacturing, and quality systems designed to manage biological variability and enable confident clinical progression.

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Manufacturing Platforms

We support a range of expansion and processing platforms and help cell therapy developers select approaches aligned to cell biology, target dose, and development stage.

  • Planar and multilayer culture systems

  • Gas-permeable and bag-based expansion platforms

  • Rocking, stirred-tank, and perfusion bioreactors

  • Fixed-bed and perfusion-based systems

  • Closed and semi-closed processing workflows
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Process & Analytical Development

Early development decisions shape MSC scalability and regulatory success. Our teams design stage-appropriate processes and analytical strategies that evolve as programs advance.

  • MSC expansion, harvest, and formulation development

  • Media and feeding strategy optimization

  • Analytical method development and qualification

  • In-process controls and release strategy design
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GMP and Non-GMP Manufacturing

We enable MSC programs across non-GMP, GMP clinical, and commercial manufacturing, enabling smooth transitions between development stages.

  • Non-GMP process confirmation and material generation

  • GMP drug substance manufacturing and drug product manufacturing

  • Single-use and closed-system processing

  • Campaign planning and execution support
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Aseptic Fill & Finish

Our fill & finish capabilities offer multiple formats while maintaining compliance and product integrity.

  • Manual and semi-automated fill options

  • Vials, cryovials, bags, and bulk formats

  • Closed and semi-closed fill workflows

  • Integration with downstream release testing
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Quality Control Testing

Quality is embedded across development and manufacturing to support consistency, data integrity, and inspection readiness.

  • Quality systems aligned with FDA, EMA, and ICH expectations

  • Batch record review and disposition support

  • Stability program execution and lifecycle management

  • Audit readiness and continuous improvement
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Regulatory Consulting

Our regulatory consulting services support MSC sponsors without overstepping sponsor ownership.

  • CMC strategy support for MSC programs

  • Contribution to IND, IMPD, and BLA documentation

  • Comparability and lifecycle strategy input

  • Inspection and health authority interaction preparation

MSC Content Library

Technical perspectives and case-based insights focused on the development, manufacturing, and scale-up of MSC therapies.

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Scale decisions for MSC manufacturing

Build in-house or partner with a CDMO
 

Scaling MSC manufacturing is not just a capacity question. This article breaks down the technical, operational, and organizational factors that influence whether building internal capability or partnering externally makes sense at different stages of development.

Read how early decisions around infrastructure, talent, and process maturity can shape long-term success.

Read Article
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From agglomeration to release

A stage-appropriate MSC process that scaled cleanly

MSC processes rarely fail all at once. They erode through small, compounding issues. This piece explores common MSC manufacturing challenges, from cell agglomeration to release testing, and outlines a development approach that enabled smoother scale-up without rework.

A practical look at designing MSC processes that hold up as programs advance.

Read Case Study
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Eleven manufacturing considerations for your MSC program

MSC development involves a series of interconnected decisions that are easy to underestimate early on. This article distills the most critical manufacturing considerations that influence scalability, consistency, and regulatory readiness across development stages.

A concise framework for teams planning their MSC manufacturing strategy.

Read Article
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Why MSCs are helping patients

Beyond manufacturing, MSCs offer unique biological properties that make them compelling across a range of therapeutic areas. This article explores how MSC mechanisms of action translate into clinical potential, and why they continue to attract interest across inflammatory and degenerative indications.

An accessible overview grounded in real-world development experience.

Read Article

How teams are advancing MSC programs

MSC sponsors apply different strategies depending on where their programs sit in development. The examples below highlight how teams translate process and manufacturing decisions into real program outcomes.

Early-stage MSC programs often need to progress quickly while process definitions are still evolving. In one program, teams worked through challenges such as cell agglomeration, process variability, and release readiness while maintaining momentum toward the clinic.

This case study illustrates how stage-appropriate process development enabled efficient clinical advancement without introducing downstream rework.

Read case study
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As MSC programs mature, the decisions that shaped early development — platform selection, analytical strategy, build vs. partner — determine whether scale feels controlled or chaotic. This article walks through the factors that influence when to build in-house, when to partner, and how to avoid the traps that stall programs between Phase I and commercial readiness.

Read Article
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Our Facilities

Our GMP facilities are designed specifically for cell therapy and actively support concurrent MSC programs across development stages

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

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

Traditional & Dedicated Service

All Clients

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

For MSC programs, this includes platform process transfer or purpose-built workflows from cell banking through drug product release.

Hybrid Client-In-Plant Operations

Mid-to-Late Stage Clients

We’ll get you started, then will get out of your way...cutting-edge labs, cleanrooms, and equipment—available in shared or dedicated settings, supported by specialized experts.

Ideal for MSC sponsors who want hands-on oversight of manufacturing while leveraging established GMP infrastructure.

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.

Designed for MSC programs approaching commercial scale with dedicated throughput requirements.

Why Made Scientific for MSCs

Active MSC programs

Currently advancing MSC programs from development through GMP manufacturing, with real-world experience across the challenges that define this modality.

MSC-specific experience

Platform-agnostic support guided by MSC biology, donor variability, and the manufacturing realities of adherent cell therapies.

Built to scale

Stage-appropriate development and clear pathways from non-GMP process confirmation through GMP clinical and commercial manufacturing.

Integrated teams

Process development, analytics, manufacturing, and quality working as one team — reducing handoffs, accelerating decisions, and protecting product quality.

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Ready to Advance Your MSC Program?

Have a question for our sales team? Contact us to explore how our expertise and capabilities can help you achieve your goals.

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