From manual process to customized automated cell manufacturing on the CliniMACS Prodigy®

Move your cell processing towards pre-clinical and clinical studies with a fully automated, GMP-compliant workflow on a closed and integrated system. Our Customized Applications Services team works with you to translate your manual protocols into a tailor-made and streamlined procedure on the CliniMACS Prodigy that meets your specific requirements. Every step is meticulously worked out with decades of experience in cell manufacturing and careful workflow design control documentation.

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What we can do for you

Every step in automated cell manufacturing on the CliniMACS Prodigy can be adapted to your specifications. In-process and quality control procedures via flow cytometry can also be tailored on a MACSQuant® Analyzer using Customized Express Modes for automated data analysis. Explore your options.

Prodigy CAPS

Choose a starting material

Whole blood, buffy coat, dissociated tissue, bone marrow, fresh, frozen, or cultured cells, or (mobilized) leukapheresis

Define the processing

Density gradient centrifugation
Red blood cell reduction
Cell wash/concentration

Design a separation strategy

Sequential depletion/enrichment
Flexible scale
Complex protocols
Target cell of choice

Optimize parameters

Purity, recovery, process time

Need genetic modification?

Select a method
Viral transduction
(e.g., lentiviral vectors)
Electroporation
Flexible parameters

Customize cell culture

Sample load
Cell wash and media change
Add feed, reagents and cytokines
Activation and expansion
Integrate in-process controls and external culture devices

Set formulation parameters

Choice of medium
Number of target cell bags
Defined cell concentration
Final formulation volume
Cell seeding and harvesting (partial, complete, to external cell culture devices)

Need automated IPC/QC?

Optionally, you can customize Express Modes software
Quick, automated flow gating
Data reporting and export

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Choose a starting material

Whole blood, buffy coat, dissociated tissue, bone marrow, fresh, frozen, or cultured cells, or (mobilized) leukapheresis

Define the processing

Density gradient centrifugation
Red blood cell reduction
Cell wash/concentration

Design a separation strategy

Sequential depletion/enrichment
Flexible scale
Complex protocols
Target cell of choice

Optimize parameters

Purity, recovery, process time

Need genetic modification?

Select a method
Viral transduction
(e.g., lentiviral vectors)
Electroporation
Flexible parameters

Customize cell culture

Sample load
Cell wash and media change
Add feed, reagents and cytokines
Activation and expansion
Integrate in-process controls and external culture devices

Set formulation parameters

Choice of medium
Number of target cell bags
Defined cell concentration
Final formulation volume
Cell seeding and harvesting (partial, complete, to external cell culture devices)

Need automated IPC/QC?

Optionally, you can customize Express Modes software
Quick, automated flow gating
Data reporting and export

Prodigy CAPS

The proof is in the service

We serve both internal and external customers. See what they appreciate about collaborating with the Customized Applications Services team.

Whether adjustments to a standard protocol, bookmarking a standard process with new input/output steps, or creating a completely new process, we use scrum to stay flexible and we work very closely with our customers at every stage.

Julia Kirchhof

Prodigy Customized Applications Product Owner, Miltenyi Biotec

Having subject matter experts at hand with exceptional proficiency allows the Customized Applications Services team to produce an outstanding process that enables a cell therapy product to exist which was previously not feasible.

Aimee-Jayne Tyler

Clinical Sales Representative UK, Miltenyi Biotec

A highlight is their guidance to clients. The Customized Applications Services team provides carefully composed and detailed documentation of planning and execution steps using recurring and easy-to-follow templates. This had a very positive effect on communication efficiency with the client.

Silvio Weber

Head of Industrial Process Development, Miltenyi

How it works

From manual process to RUO Customized Application

Our Customized Applications Services team manages every step of translating a manual manufacturing process into a fully automated workflow on the CliniMACS Prodigy. First, we develop an RUO process development Customized Application that maintains flexibility and optimization options to find ideal process settings.

1. Interview

We work with you to define the design and functional specifications based on your manual process.

2. Develop Customized Application

We translate the defined specifications into a Customized Application.

3. Deploy & train

We install the Customized Application onsite and train users.

4. Evaluate process

You evaluate performance of the Customized Application and then optimize it with Miltenyi experts.

From RUO Customized Application to GMP-supportive Customized Application

In a second-tier project, the RUO process development Customized Application can be transferred to a verified GMP-supportive Customized Application, including installation, operational qualification and phase-appropriate documentation. The GMP-supportive Customized Application can be integrated into clinical manufacturing processes after customer validation.

1. Freeze Design

We work with you to define the design input for the GMP-supportive Customized Application.

2. Optimize program

We configure the Customized Application according to the defined design input.

3. Verify

We perform a functional verification.

4. Install & Operational Qualification

We perform with you an Installation and Operational Qualification of the GMP-supportive Customized Application onsite, which you then validate.

CliniMACS Prodigy. Expect quality and nothing less.

International quality standards (ISO) exist to guarantee consistency and reproducibility. We are certified and regularly audited to these standards as a commitment to our customers so that your custom product is delivered the same way every time.

You can be confident in our ability to manufacture software products and components reproducibly and provide the required quality documentation.

Discover what’s possible.

Get in touch with our experts

For complete regulatory notes, please click here.
Unless otherwise specifically indicated, Miltenyi Biotec products and services are for research use only and not for therapeutic or diagnostic use.

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