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Miltenyi Bioindustry: Delivering end-to-end CDMO services in Cell and Gene Therapy

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Miltenyi Bioindustry is a global CDMO service provider specializing in cell and gene therapy. With more than 25 years of experience, we offer comprehensive process development and manufacturing services for both autologous and allogeneic cell therapy programs. We provide high-quality lentiviral vector production and regulatory support that smooths our customers’ paths from clinical to commercial.

Five reasons to believe in Miltenyi Bioindustry:

• 100+ GMP batches of lentiviral vectors produced

• 400+ customers using our leading analytical and processing technology platforms

• 180+ supported clinical trials

• 50+ countries’ worth of regulatory experience

• 25+ years of experience

1. 1. Cell and gene therapy services

Whether you are working with autologous or allogeneic CGT products, we transfer your cell-based therapeutic processes to the industry-standard CliniMACS Prodigy® Platform for advanced manufacturing. We are committed to providing you with analytical and manufacturing processes that are ready for clinical and commercial production, tailored to your specific approach. This makes us a fully integrated, end-to-end CDMO

Cell and gene therapy instruments at their core

Miltenyi Bioindustry tackles the complexity of cell manufacturing using Miltenyi Biotec's clinically proven CGT instrument platforms; we provide the expertise and tools needed for flexible process development and standardized manufacturing.

Our range of advanced instruments includes:

1. 2. Lentiviral vector services

Lentiviral vectors (LVVs) play a pivotal role in cell and gene therapy by facilitating the delivery of therapeutic genes to target cells. Our LVV platform ensures reliable production of high-quality vectors from preclinical to commercial scales. Our decades of experience let us move directly from 4 L demonstration batches to 50 and 200 L production scales to achieve GMP runs in a fast-track process, saving costs and valuable time.

1. 3. Quality and regulatory support

Our regulatory support services are tailored to guide you through the regulatory requirements for cell and gene therapies. We work with you to ensure that the Miltenyi instruments and products used for your product manufacturing meet regulatory standards to accelerate your regulatory submissions for IND to Market Approval.

With our proven expertise, end-to-end services, innovative yet proven technologies, and collaborative approach, Miltenyi Bioindustry will accelerate your journey towards commercialization. Trust us to unlock the full potential of your innovative therapies and reach out today to learn more.

Connect with us

Let’s explore your project needs and timelines

www.miltenyibioindustry.com

Miltenyi Biotec, Inc. | Phone +1 866 811 4466 | Fax +1 530 745 2806 | bioindustry@miltenyi.com | Visit www.miltenyibioindustry.com to find your nearest Miltenyi Bioindustry contact. Unless otherwise specifically indicated, Miltenyi Biotec products and services are for research use only and not for therapeutic or diagnostic use. CliniMACS Prodigy®, MACSQuant® Tyto® and MACSQuant® Analyzer are registered trademarks or trademarks of Miltenyi Biotec and/or its affiliates in various countries worldwide. Copyright © 2023 Miltenyi Biotec and/or its affiliates. All rights reserved

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