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Regulatory Considerations For Alternative Microbial Methods

Biopharma 4.0: Convergence Of Information, Operations, And Processing Tech

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ABOUT MILLIPORESIGMA

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.

Browse our capabilities now

VIDEOS

Real-Time Monitoring And Automated Sampling For Enhanced Efficiency

MilliporeSigma Bio-Expo Live February 2025: Downstream Bioprocessing

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Master mRNA Manufacturing, Purification, And Plasmid DNA Processes

Master Your mRNA Manufacturing

Optimize Downstream For Your mRNA Template

Streamline Your mRNA Purification Steps

Empowering Your Plasmid DNA Workflow

Your Roadmap For Efficient Processes

How To Improve API Solubility By Salt And Cocrystal Formation

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