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.
VIDEOS
HOT PRODUCTS
-
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.
BROCHURES
- A Complete Set Of Rapid Methods For Adventitious Agent Detection
- Custom Research-Grade mRNA Manufacturing Services
- Robocolumn® And MiniChrom Chromatography Columns
- Viral Clearance Studies To Meet Your Timelines
- Viral Vector CTDMO Services
- Mammalian Biologics CDMO Services To Bring Your Program To The Next Stage
- Accelerating Adenovirus-Based Cell And Gene Therapy Manufacturing
- Complete Sterility Testing Solutions For Complete Confidence
- Sterility Testing Media And Rinse Fluids
- A Platform For Lentivirus-Based Cell And Gene Therapy Manufacturing
WEBINARS AND PODCASTS
PRODUCT GUIDES, DATA SHEETS & APPLICATION NOTES
- Accelerating The Development And Optimization Of Cell Culture Media
- Integrated Services For Cell Line Preparation And Storage
- Optimizing Virus Bank Manufacturing
- Custom Research-Grade mRNA Manufacturing Services
- Robocolumn® And MiniChrom Chromatography Columns
- Accelerating Bulk Harvest Release Testing With A PCR-Based Solution
- Monitoring Bioprocesses In A Light Environment Using Raman Spectroscopy
- Cell-Free Modeling Approach For Efficient Cell Culture Monitoring
- Raman As A Quality Control Tool For Cell Culture Media Preparation
- Real-Time And In-Line Raman Spectroscopy For Glycan Quality Analysis
NEWS
- MilliporeSigma Announces Siren Biotechnology As Winner Of Its North American Advance Biotech Grant
- MilliporeSigma Expands Its Optimized VirusExpress® Platform For Lentiviral Vectors, Further Enhancing Quality And De-Risking Cell And Gene Therapy Manufacturing
- MilliporeSigma Announces Support Of SaudiVax In Becoming First Developer And Manufacturer Of Halal Vaccines And Biotherapeutics In Saudi Arabia
- MilliporeSigma To Manufacture Next-Generation Biotherapeutics For Alteogen
- MilliporeSigma Announces Organizational Transformation To Strengthen CDMO Offering And Accelerate Future Growth
- MilliporeSigma's Bio4C Orchestrator™ Software Optimizes Processes, Improves Compliance And Time To Market
- MilliporeSigma Advances Bioprocessing Capabilities With Raman Technology Sensor Acquisition
- MilliporeSigma Accelerates Readiness Of Bioprocessing Facility Of The Future
CONTACT INFORMATION
MilliporeSigma
400 Summit Drive
Burlington, MA 01803
UNITED STATES
Phone: 978-762-5100
NAVIGATING THE EMERGING BIOTECH ECOSYSTEM
FEATURED ARTICLES
-
Here, we outline the use of a microbioreactor for the rapid screening and optimization of media formulations for perfusion processes, and its role in predicting the performance of larger-scale bioreactors.
-
Explore common process-related impurities found in recombinant Adeno-Associated Virus (rAAV) vectors and the analytical testing methods used for these residuals.
-
Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.
-
Explore a comprehensive suite of services for the manufacture, characterization, and storage of cell banks as well as the advantages of working with an experienced partner.
-
Explore the regulatory requirements for mRNA drug substances and products, the importance of phase-appropriate quality, and insights on creating CMC documentation to ensure compliance.
-
Discover a CHO AOF panel that provides rapid detection of relevant adventitious viral contaminants in bulk harvest material, and explore data showing equivalent sensitivity to the in vitro assay.
-
Explore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.
-
For ADC developers, obtaining the desired payload can be a challenge, as their synthesis is more complex than most other small molecules. Learn about a more efficient approach to payload synthesis.
-
Business continuity management is a key success contributor to the pharma industry. Explore best practices for a robust supply chain and how they can translate into success stories.
-
Gain insight into two cases where clients were enabled to overcome obstacles during virus bank manufacturing.
-
Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.
-
The complexity of manufacturing AAV products, coupled with the challenges linked to controlling their costs, underscore the importance of improving the efficiency and scalability of these processes.
-
Adventitious agent testing is frequently a bottleneck in downstream processing. Discover a PCR-based solution for manufacturing processes using CHO cells and animal origin-free components.
-
Discover an advanced solution to facilitate the implementation of Raman technology at both laboratory and manufacturing scales in a normal light environment.
-
Learn about a novel cell-free modeling method for the efficient monitoring of cell cultures that has significant advantages over traditional approaches.
-
Explore study results demonstrating how Raman technology easily differentiates between media with similar compositions and detects potential preparation errors that other analysis methods might miss.
-
This study details the use of in-line Raman spectroscopy to monitor mAb glycan profiles within a production bioreactor, highlighting its potential for automation and customization.
-
This study evaluates an innovative workflow designed to streamline the integration of an in-line Raman analyzer for bioreactor applications.
-
Standard methods for building Raman spectroscopy models are often time-consuming and resource-intensive. Explore one-batch calibration and how its performance compares to other modeling techniques.
-
Speed and flexibility are crucial in the development of a new drug, from the laboratory to clinical trials and ultimately to the market. Explore considerations for a successful technology transfer.