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CDMO Services
Process & Analytical Development
A scientist's gloved hands working in a cell therapy lab

Process & Analytical Development for Cell Therapies

Development that carries into GMP manufacturing, with process and analytical teams that work together.

About

You get process and analytical development teams that work together, and with the manufacturing, quality control, and regulatory teams that come next.

Processes are designed to scale, using Design of Experiments and quality by design, and methods are developed to be qualified and validated, so both move into GMP without starting over.

Services

  • Scalable process development

  • Analytical development

  • Technology transfer and MSAT

  • Cryopreservation

  • ReadyMADE™ platform processes

Our Capabilities

Our approach combines risk assessment, Design of Experiments, process analytical technology, statistical analysis, and process modeling for continuous process verification.

Optimization and Scale-Up

Feasibility and process work that sets a program up to scale.

  • System and bioreactor feasibility studies

  • Process development for closed, automated platforms

  • Transduction and transfection efficiency

Unit Operations

Development across the steps of your process.

  • Cell sourcing and donor selection for autologous and allogeneic therapies

  • Isolation and enrichment by magnetic bead selection and FACS

  • Expansion of adherent and suspension cultures

  • Formulation and media optimization

Cryopreservation

Freezing protocols that hold up as you move toward the clinic.

  • Cryoprotectant formulation

  • Controlled-rate freezing protocols that support GMP and commercial readiness

Analytical Development

Methods developed to characterize, monitor, and control your cell therapy, then qualified and validated for release and stability testing.

  • Method development, transfer, and optimization

  • Method qualification and validation per ICH guidelines

  • Identity, potency, purity, and safety

  • Stability-indicating methods

Technology Transfer

Moving processes between development stages, between sites, and between companies.

  • Gap analysis between sending and receiving sites

  • Transfer protocols and success criteria

  • Knowledge transfer and operator training

  • Comparability assessment and strategy

MSAT

Our Manufacturing Science and Technology team supports the process over time.

  • Process characterization and validation support

  • Deviation investigation and troubleshooting

  • Scale-up and scale-out strategy

  • Process risk assessment and mitigation

How teams move toward GMP

Development decisions made early shape what happens at GMP. These are two of the routes teams take.

Teams come to us from academic labs or another CDMO, moving into Made Scientific’s GMP manufacturing. We support analytical method transfers between laboratories, scale-up from development to clinical and commercial manufacturing, and site-to-site transfers with Person-In-Plant support.

See the live page
A Made Scientific scientist in a lab

ReadyMADE™ platform processes are there for programs that can start from a proven process, with pre-existing master batch records and SOPs, trained personnel with completed aseptic validation, and a pre-sourced bill of materials.

See ReadyMADE™ Platforms
A Made Scientific scientist in a process development lab

Why Made Scientific for Process Development

Cell therapy focus

Development across T cells, B cells, NK cells, HSCs, MSCs, iPSCs, TILs, and exosomes.

Quality by design

DoE studies that define critical process parameters and how they affect quality attributes.

Phase-appropriate analytics

Characterization and release methods that mature with the program.

Ready for transfer

Processes and methods designed to move into GMP manufacturing and QC.

Process Development Insights

Technical perspectives from Made Scientific.

Structuring your quality by design framework

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

Read Article

Strategies for a successful tech transfer

A Made Scientific article on moving a cell therapy process between teams and sites.

Read Article

Translating Innovation

Made Scientific's eBook guide to cell therapy manufacturing.

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
Made Scientific - Interactive Background

Accelerate Your Cell Therapy Development

Tell us where your process stands today. We’ll scope the development work to get it ready for GMP manufacturing.

Example page for review. Not published by Made Scientific.