Article Provided by Miltenyi Biotec
Despite a turbulent market environment, the cell and gene therapy (CGT) field continues to advance, with several groundbreaking therapies slated to receive FDA approval this year alone. The momentum is undeniable. However, the path from clinical development to market approval remains challenging. Manual and fragmented workflows, scalability issues, siloed analytics, and limited technical support are just a few of the hurdles CGT developers must overcome.
At Miltenyi Biotec, we know that starting with the end goal in mind and working with an experienced partner can empower you to reach your milestones sooner. To that end, we’ve built a proven platform where manufacturing meets analytics – where the CliniMACS Prodigy® pairs with the MACSQuant® Analyzer. The perfect match, if you will.
By optimizing manufacturing and analytics side-by-side, we propel your cell product to commercial success focusing on four key pillars: automation, integration, scalability, and services. This is their impact.
Automation: establish future-ready manufacturing early on
A streamlined, scalable, and high-quality manufacturing process necessitates automation. Reduced manual intervention accelerates development, increases productivity, and ensures consistency, ultimately driving down costs and minimizing errors.
For over a decade, CliniMACS Prodigy has led the way in automated cell processing for autologous and allogeneic approaches in point-of-care and centralized production settings. As an automated and closed platform, CliniMACS Prodigy integrates all essential processing steps – from cell washing to final formulation – into one efficient application. At least six approved cell therapies in the US and Europe are manufactured on the CliniMACS Prodigy, and many more are in the pipeline.
Successful and efficient cell manufacturing processes require the same level of automation and scalability for their accompanying analytics. So, we’ve developed a unique analytical platform centered around the MACSQuant Analyzer to offer comprehensive automation options, from routine instrument maintenance and automated sample labeling to acquisition with advanced algorithm-driven data analysis.
Our Express Mode software features are the gateway to this level of automation. They encompass standardized instrument setups, predefined experiment settings, and automated acquisition, gating, and reporting. Moreover, our dedicated Custom Express Modes Services can customize every step of the analytical process to meet your specific needs.
Couple the Express Modes on the MACSQuant Analyzer with our extensive portfolio of highly specific REAfinity® Antibodies available in various product formats and our 21 CFR Part 11 compliant software module for automated documentation and reporting to unlock the full potential of our all-in-one analytics solution.
Why automation matters.
Integration: the end of patched-together workflows
Integrating reliable analytics into cell manufacturing is crucial for the timely release of safe and effective products. However, using disconnected technologies with incoherent workflows disrupts smooth and efficient processing.
Our platform and applications are co-developed into one end-to-end workflow across manufacturing and analytics. With harmonized consumables, high-performance instruments, expert support, and tailored training courses, each deployment shortens your development times.
Workflow integration – processing meets analytics
With a user-friendly interface that guides you through processing steps, each instrument software compiles reports on activities and results from both the CliniMACS Prodigy and the MACSQuant Analyzer. In addition, both instruments support 21 CFR part 11 compliance according to regulatory guidelines to accelerate your path to market success.
Scalability: meet commercial demands on your terms
Only scalable manufacturing and analytics processes can deliver the efficiency, cost savings, and accessibility that commercial cell products require for success without compromising on quality. Aiming for scalable processes early in development prevents unwanted delays down the road.
The perfect match of CliniMACS Prodigy and MACSQuant Analyzer is designed for effortless scalability. Instrument alignment eases technology transfer between different production sites or external partners around the globe. Thus, while the CliniMACS Prodigy enables parallel manufacturing at any scale, the MACSQuant Analyzer complements this flexibility by facilitating inter- and intra-instrument alignment (Smart Gain Technology) for reproducible performance across sites, and by allowing various degrees of robotic integration.
Besides, both instrument platforms are the core of the globally established CliniMACS Cell Factory® – a standardized yet fully configurable facility design blueprint that is rapidly deployed and suits both centralized and decentralized manufacturing models.
Set on a harmonized manufacturing platform for global expansion.
Services: support throughout your journey
Instrument downtime poses a serious threat to efficiency and consistency. Thus, working with a partner that complements end-to-end solutions with assured operational performance and regulatory compliance of instruments is indispensable. With decades of clinical expertise, our expert teams help clear roadblocks and anticipate turning points in your journey.
At Miltenyi Biotec, our goal is to speed up your CGT journey. We offer hands-on and online training courses to make you an expert user of our products in no time. Our service contracts cover maintenance, repair, support, and qualification services that safeguard the long-term performance of your instruments. In addition, our regulatory support team helps you navigate requirements from clinical trial submission to market approval. Lastly, any cell processing or analytical step can be customized to your specific needs by our dedicated Custom Application Services team.
Let a perfect match realize your CGT vision.
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