The growing demand for new therapies, persistent pressure to reduce costs, and the clinical success of novel modalities are driving the biopharmaceutical industry to adopt new strategies to increase the speed, efficiency, and agility of manufacturing. A variety of approaches are available to address these imperatives.

Monoclonal antibodies (mAbs) and recombinant proteins have templated production workflows. Here, the focus is on exploring and integrating strategies defined by Biopharma 4.0 – the digital transformation to intensified, closed, connected, or continuous processing. For these companies, the key question is: “Where do I begin?”

In contrast, relatively new modalities such as mRNA and cell and gene therapy present different challenges. Cell and gene therapies are highly complex, lack a manufacturing template, and innovators must operate in a regulatory environment that continues to evolve. When developing and manufacturing mRNA-based therapeutics, among the most pressing objectives are to improve process efficiency and mRNA product stability.

For innovators of these novel modalities, access to new technologies and a breadth of expert services are critical success factors as they ask: “How can I improve my process?”

MilliporeSigma, the life science business of Merck KGaA, Darmstadt, Germany, empowers you to optimize and streamline your development and manufacturing processes. Whether you are producing mAbs and recombinant proteins, or highly complex, novel modalities, we will help you meet your goals for speed, efficiency, and agility.

We offer a convergent end-to-end portfolio of advanced, closed processing-ready technologies with extensive documentation for upstream and downstream operations, process analytical technologies (PAT), data analytics, automation and control software, contract testing and analytical development services, non-GMP environment labs, and CTDMO services for mAbs, high potency active pharmaceutical ingredients (HPAPIs), antibody drug conjugates (ADCs), mRNA, and lipid nanoparticle (LNP) formulation.

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  • Perfusion at process development scale

    The Mobius® Breez Microbioreactor is a 2 mL automated single-use perfusion cell culture platform designed to support gentle, adaptable, and reproducible cell processes.

  • Designed to purify biologics at clinical and process scale, the Mobius® FlexReady Solution with Smart Flexware® Assemblies is flexible, allowing you to have a single system for tangential flow filtration (TFF) at various scales.

  • Bio4C Orchestrator™ connects to individual unit operations from a centralized “orchestration layer” for complete visibility, monitoring, and management of regulatory-compliant biomanufacturing systems and processes. The software's consolidated control optimizes processes improving quality and compliance while reducing human errors and operating costs.

  • To ensure optimum equipment uptime and regulatory compliance while mitigating risks, MilliporeSigma has developed System Service Reliance Plans; a complete range of services for your systems and equipment. These comprehensive service and support packages allow you to select a coverage level that best fit your needs

  • MilliporeSigma’s Mobius® single-use mixing solutions deliver advanced technology for mixing pharmaceutical ingredients from intermediate to final drug products and for the preparation of process solutions, such as buffers and media. Unlike traditional stainless-steel mixers, single-use mixers reduce downtime due to CIP, SIP, cleaning validation, and process engineering. Mobius® single-use mixing solutions also offer operational flexibility as they can be up and running in less than five minutes. They are capable of mixing speeds up to 1000 RPMs meeting the broadest range of mixing production requirements. Mobius® flexibility offers you a choice of just the right filter, connector, tubing options for your specific application and environment, including sterile interfaces, from fermentation to final fill. Sizes range from 10 L to 3000 L.

  • You’re developing lifesaving gene-modified cell therapies and need to manufacture lentiviral vector as quickly as possible. But scale-up and regulatory hurdles make the path to the clinic slow and labor intensive.

    We're here to help.

  • From your bioreactor to final sterile filtration, the new NovaSeptum® GO sampling system lets you sample processes the way you want. Flexible formats and volumes adapt to your process for robust, reliable monitoring and quality assurance.

  • Cell culture media are important for process efficiency and mAb quality. Production media support initial cell growth and production, while the feeds replenish depleted nutrients required for cellular function and maintain and extend the production phase in fed-batch mode.

  • Cellvento® CHO media are designed to support growth and maintenance of specific CHO cell lines in suspension cell culture for expression of monoclonal antibodies and recombinant proteins. The new Cellvento® 4CHO-X Expansion Medium supports cell expansion including N-1 perfusion for Chinese Hamster Ovary (CHO) cell lines.

  • In recent years, the development of media used to expand and mature adult stem cells has greatly increased the success rate of adult stem cell therapy and the breadth of potential stem cell-based therapies. To obtain enough cells, ex vivo expansion has been utilized to ensure successful engraftment and economize the manufacture of both allogeneic and autologous therapies.



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